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Effect of a Healing Program Using Marine Resources on Reducing Pain and Improving Physical Function in Patients with Non-Specific Chronic Low Back Pain: A Randomized Controlled Trial Study

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Background and Objectives: Chronic low back pain is a widespread condition, particularly in older populations, contributing to physical, mental, and social burdens. Traditional treatments, such as medications and surgery, carry long-term risks, including dependency, side-effects, and complications from invasive procedures. Additionally, healthcare accessibility is limited due to high costs, long waiting times, and geographic disparities in healthcare services, particularly in rural areas. For these reasons, non-pharmacological approaches that address both physical and psychological aspects are increasingly recognized as effective. This study aimed to evaluate the effectiveness of a marine resource-based healing program in Taean, South Korea, in improving pain, physical function, and mental health in patients with non-specific chronic low back pain. Materials and Methods: This randomized controlled trial involved 46 participants with non-specific chronic low back pain (mean age, 68.7 ± 5.1 years), randomly allocated to either an experimental group (marine healing program) or a control group (core exercises). The experimental group participated in a 4-night, 5-day intervention comprising heated peat pack therapy, mindfulness meditation, core exercises, and local tourism. The control group performed core exercises without additional interventions. Key outcomes included pain, muscle properties, functional disability, lower extremity function, balance, gait, and depression. Results: The experimental group demonstrated significant reductions in resting pain (p < 0.001), improved pressure pain threshold at L3 (p < 0.001), decreased L3 muscle tone (p = 0.015), and improved functional disability scores (p < 0.001). Functional gains were observed in lower extremity function scores (p < 0.001), balance (sway area: p = 0.046), gait velocity (p < 0.001), and depression levels (p < 0.001). Conclusions: The marine healing program significantly improved pain, functional abilities, and mental well-being in patients with non-specific chronic low back pain, highlighting its potential as an integrative approach to chronic low back pain management. Further studies are recommended to explore long-term and generalized effects.
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Academic Editor: Nicola Luigi
Bragazzi
Received: 31 December 2024
Revised: 16 January 2025
Accepted: 19 January 2025
Published: 21 January 2025
Citation: Baek, J.-E.; Kim, S.-H.; Shin,
H.-J.; Cho, H.-Y. Effect of a Healing
Program Using Marine Resources on
Reducing Pain and Improving
Physical Function in Patients with
Non-Specific Chronic Low Back Pain:
A Randomized Controlled Trial Study.
Medicina 2025,61, 172. https://
doi.org/10.3390/medicina61020172
Copyright: © 2025 by the authors.
Published by MDPI on behalf of the
Lithuanian University of Health
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(https://creativecommons.org/
licenses/by/4.0/).
Article
Effect of a Healing Program Using Marine Resources on
Reducing Pain and Improving Physical Function in Patients with
Non-Specific Chronic Low Back Pain: A Randomized Controlled
Trial Study
Ji-Eun Baek 1, , Sung-Hyeon Kim 1, , Ho-Jin Shin 2and Hwi-Young Cho 1,*
1Department of Physical Therapy, Gachon University, Incheon 21936, Republic of Korea;
baekjieun421@gmail.com (J.-E.B.); gpgkorea30@gmail.com (S.-H.K.)
2Wellness Center, Industry-University Collaboration Group, Ansan University,
Ansan 15328, Republic of Korea; hojin0911@ansan.ac.kr
*Correspondence: hwiyoung@gachon.ac.kr; Tel.: +82-32-820-4560
These authors contributed equally to this work.
Abstract: Background and Objectives: Chronic low back pain is a widespread condition,
particularly in older populations, contributing to physical, mental, and social burdens.
Traditional treatments, such as medications and surgery, carry long-term risks, including
dependency, side-effects, and complications from invasive procedures. Additionally, health-
care accessibility is limited due to high costs, long waiting times, and geographic disparities
in healthcare services, particularly in rural areas. For these reasons, non-pharmacological
approaches that address both physical and psychological aspects are increasingly recog-
nized as effective. This study aimed to evaluate the effectiveness of a marine resource-based
healing program in Taean, South Korea, in improving pain, physical function, and mental
health in patients with non-specific chronic low back pain. Materials and Methods: This
randomized controlled trial involved 46 participants with non-specific chronic low back
pain (mean age, 68.7
±
5.1 years), randomly allocated to either an experimental group
(marine healing program) or a control group (core exercises). The experimental group
participated in a 4-night, 5-day intervention comprising heated peat pack therapy, mind-
fulness meditation, core exercises, and local tourism. The control group performed core
exercises without additional interventions. Key outcomes included pain, muscle properties,
functional disability, lower extremity function, balance, gait, and depression. Results: The
experimental group demonstrated significant reductions in resting pain (p< 0.001), im-
proved pressure pain threshold at L3 (p< 0.001), decreased L3 muscle tone (p= 0.015), and
improved functional disability scores (p< 0.001). Functional gains were observed in lower
extremity function scores (p< 0.001), balance (sway area: p= 0.046), gait velocity (p< 0.001),
and depression levels (p< 0.001). Conclusions: The marine healing program significantly
improved pain, functional abilities, and mental well-being in patients with non-specific
chronic low back pain, highlighting its potential as an integrative approach to chronic
low back pain management. Further studies are recommended to explore long-term and
generalized effects.
Keywords: non-specific chronic low back pain; marine therapy; physical health; psychological
health
Medicina 2025,61, 172 https://doi.org/10.3390/medicina61020172
Medicina 2025,61, 172 2 of 15
1. Introduction
Back pain is a common health problem worldwide, and its prevalence is increasing, es-
pecially due to population aging and lifestyle changes [
1
4
]. Chronic low back pain (CLBP)
continues to be defined as pain localized in the lumbar region, lasting for at least half the
days in the past 6 months without an identifiable specific pathology [
5
]. It is particularly
prevalent among women and individuals aged 40 to 80, but recent studies have highlighted
a growing incidence among younger adults, driven by sedentary lifestyles, prolonged
sitting, and reduced physical activity [
6
]. This trend underscores the need for proactive
management across all age groups. However, older adults face distinct challenges, includ-
ing a higher prevalence of comorbidities, reduced mobility, and greater vulnerability to the
long-term risks associated with conventional treatments, such as medication dependency
and surgical complications [
7
]. Furthermore, healthcare accessibility issues—particularly
for rural or underserved populations—make non-pharmacological, integrative approaches
more critical for this demographic. These approaches, which address both physical and
psychosocial aspects, are vital for reducing the overall disease burden, improving patient
outcomes, and lowering healthcare costs, especially in older adults with limited access to
specialized care.
In particular, the management of non-specific chronic low back pain (NSLBP) has
emerged as an important task in public health [
8
]. Because the pathoanatomical cause of
NSLBP is unclear, a customized, non-pharmacological treatment approach that goes beyond
pain relief to address psychosocial and lifestyle factors is required. Such management plays
a vital role in reducing the overall burden of disease and improving patient outcomes by
lowering healthcare costs and enhancing productivity.
Current approaches to managing low back pain have several limitations and chal-
lenges. Most treatments are hospital-based, limiting patient access, and drug treatments, in
particular, carry the risk of developing resistance [
9
]. Additionally, surgery is considered a
last resort for chronic low back pain, which increases the burden on patients and limits the
sustainability of treatment. To address these issues, there is a growing need for safe and
accessible alternative treatment methods. Heat therapy and exercise have been proposed
as effective, low-risk alternatives. Heat application is widely used to relieve chronic muscu-
loskeletal pain, while exercise plays a critical role in alleviating pain, improving muscle
strength, and enhancing motor function in patients with NSLBP.
The integration of neuroscience-based pain education (PNE) with exercise therapy
has demonstrated promising results in managing non-specific chronic low back pain
(CLBP). PNE educates patients about the biological and physiological mechanisms of
pain, fostering improved self-management and reducing fear-avoidance behaviors. When
combined with neuromuscular or targeted exercise programs, this approach effectively
alleviates pain intensity, reduces functional disability, and addresses psychological barriers
such as kinesiophobia and catastrophizing beliefs. For instance, a study evaluating the
effects of an eight-week PNE and neuromuscular exercise program reported significant
improvements in pain, disability, and fear-avoidance behaviors compared to exercise
alone [
10
]. Similarly, research indicates that combining PNE with motor control training
yields greater reductions in central sensitization and psychological distress than standalone
interventions [
11
]. Furthermore, a multimodal approach incorporating PNE, physical
exercises, mindfulness, and behavior change strategies has been shown to enhance overall
health outcomes and reduce reliance on primary healthcare services [12].
Additionally, previous studies have demonstrated the effectiveness of various physical
and occupational therapy interventions for managing chronic low back pain, including
core stabilization exercises, aquatic therapy, manual therapy, and psychosocial approaches
such as cognitive-behavioral therapy (CBT) and yoga. These interventions have shown
Medicina 2025,61, 172 3 of 15
significant benefits in reducing pain, improving function, and enhancing mental well-
being [
13
17
]. Nonetheless, clinical trials on interventions for chronic NSLBP remain
insufficient [18].
The effective management of chronic back pain must go beyond physical treatment to
comprehensively address the patient’s psychological, mental, and emotional state. Recent
studies have demonstrated that these factors significantly influence the occurrence, per-
sistence, and chronicity of low back pain, suggesting that psychosocial approaches, such
as cognitive behavioral therapy, may be effective [
19
22
]. Thus, in the management of
chronic low back pain, understanding and addressing psychological, mental, and emotional
factors are as important as physical treatment, making the development and application of
integrated treatment approaches essential.
Taean’s marine environment provides ideal conditions for managing chronic back
pain, offering an abundance of marine resources and natural healing properties. This
region is rich in healing resources, particularly peat, which is a decomposed organic
material found in wetland environments. Rich in humic acids and minerals, peat possesses
anti-inflammatory and thermotherapeutic properties, making it effective for managing
musculoskeletal pain [
23
,
24
]. Additionally, Taean’s natural environment supports healing
programs that leverage elements such as sunlight, the sound of waves, and fresh air, all
of which contribute to improved physical and mental health [
25
,
26
]. Research has shown
that visiting natural environments reduces depression and high blood pressure, viewing
natural scenery alleviates pain and anxiety, and sunlight exposure is especially beneficial in
improving mood [
27
,
28
]. Exercise in a marine environment like Taean can enhance mental
health, while elements such as ocean sounds and sand have potential for use in natural
healing programs [
29
31
]. Taean’s unique environment presents a novel direction in the
utilization of natural healing resources for chronic pain management and can become a
cornerstone of preventive medicine.
This study aims to contribute to the development of an integrative and sustainable non-
pharmacological management approach for non-specific chronic low back pain (NSLBP),
with a particular focus on utilizing marine resources. This novel intervention seeks to
complement existing hospital-based treatments by addressing physical, psychological, and
environmental factors.
The primary purpose of this study is to evaluate the effectiveness of a healing program
utilizing marine resources for patients with non-specific chronic low back pain (NSLBP).
This study hypothesizes that this marine healing program will be more effective than
conventional core exercises in reducing pain, improving function, and promoting men-
tal health.
2. Materials and Methods
2.1. Study Design
This study was conducted as a single-blinded, randomized controlled study. To main-
tain blinding, data were coded to ensure that the analyst was unaware of the participants’
group allocations.
2.2. Participants
Participants in this study were recruited through poster advertisements and coopera-
tion with the Taean County Health and Medical Center located in Taean, Chungcheongnam-
do. Among the volunteers who wanted to participate, those who reported a pain score of 3
or higher on the visual analog scale (VAS) at rest in the back and legs, had pain for more
than 6 months, and required medication to relieve pain were recruited. The exclusion crite-
ria were as follows: (1) individuals requiring other medical, pharmacological, or alternative
Medicina 2025,61, 172 4 of 15
treatments for back pain symptoms during the intervention period, (2) individuals with
musculoskeletal conditions (including a history of surgery) or pain caused by identifiable
neurological pathologies that could affect measurements, (3) individuals who had difficulty
communicating in Korean, and (4) individuals at risk of mental health issues as indicated
through self-report.
A total of 46 patients with back pain who met the criteria ultimately participated
in the experiment. Before participating in this study, all subjects signed an informed
consent form after receiving an explanation of the study. This study was conducted after
receiving approval from the Gachon University Institutional Review Board (approval
number: 1044396-202108-HR-181-01 and 9 October 2021) and was registered with the
Clinical Research Information Service of the Korea Disease Control and Prevention Agency
(registration number: KCT0009103).
2.3. Sample Size
The software G*Power 3.1.9.7 (Universität Kiel, Kiel, Germany) was used to calculate
the sample size. According to the study by Faul et al., the effect size was set at 0.25, 80%
power, and
α
= 0.05, requiring 34 participants. Considering a dropout rate of 20%, a total of
51 participants were recruited, and ultimately 46 participants completed this study.
2.4. Study Sites
The intervention in this study was divided into an experimental group and a control group.
The experimental group conducted activities at a training center located in
Cheongpodae-gil, Nam-myeon, Taean-gun, Chungcheongnam-do, South Korea. The
nearby Cheongpodae Beach consists of a dense pine forest and a wide sandy beach. The
white sandy beach, composed of silica sand, spans an area of 30,000 m
2
, with a length
of 1000 m and a width of 30 m. Its gentle slope of 6 degrees makes it suitable for beach
trekking [32].
In contrast, the control group performed core exercises between their home and school
without separate accommodation.
2.5. Procedure
Participants, selected after considering the inclusion and exclusion criteria, signed the
consent form for participation in this study and completed pre-intervention measurements.
They were then randomly assigned to one of two groups (experimental or control group)
and participated in their respective interventions for 4 nights and 5 days. Random allocation
in this study was performed using Microsoft Excel (Microsoft Corp., Redmond, WA, USA),
where participants were randomly assigned to the experimental and control groups using
blocks of size 4. Randomization was performed by a physical therapist who was blinded
to the study hypothesis and group assignments. Post-measurements were conducted
immediately after completing the interventions (Figure 1).
All interventions and measurements were conducted by licensed physical therapists
with more than 3 years of clinical experience. These therapists were not involved in the
recruitment of participants, to ensure objectivity.
Medicina 2025,61, 172 5 of 15
Medicina 2025, 61, x FOR PEER REVIEW 5 of 16
Figure 1. Flowchart.
All interventions and measurements were conducted by licensed physical therapists
with more than 3 years of clinical experience. These therapists were not involved in the
recruitment of participants, to ensure objectivity.
2.6. Intervention
Participants performed the assigned interventions for 4 nights and 5 days (Table 1).
The experimental group underwent a program involving heated peat packs, core exer-
cises, mindfulness meditation, and local tourism, while the control group performed only
core exercises in the city center.
Table 1. Schedule of the experimental group.
Time Day 1 Day 2 Day 3 Day 4 Day 5
07:00–
08:00
Coastal walk Coastal walk Coastal walk Coastal walk
08:00–
09:00 Breakfast Breakfast Breakfast Breakfast
09:00–
10:00 CORE exercise CORE exercise CORE exercise CORE exercise
10:00–
11:00
Mindfulness
meditation
Mindfulness
meditation
Mindfulness
meditation
Mindfulness
meditation
11:00–
12:00 Break time Break time Break time Post-measure-
ment
12:00–
13:00 Lunch Lunch Lunch
13:00–
14:00 Orientation CORE exercise CORE exercise CORE exercise Lunch
14:00–
15:00
Pre-measure-
ment
Nordic walk-
ing
Visiting
Cheongsan
Tideland activ-
ity Check-out
Figure 1. Flowchart.
2.6. Intervention
Participants performed the assigned interventions for 4 nights and 5 days (Table 1).
The experimental group underwent a program involving heated peat packs, core exercises,
mindfulness meditation, and local tourism, while the control group performed only core
exercises in the city center.
A heated peat pack, maintained at 40
C, was applied to the experimental group for
40 min on the area experiencing back pain. An electric heating pack ensured consistent
heat conduction. Mindfulness meditation, focusing on breathing and bodily sensations,
was provided to the experimental group as part of a marine healing program. Previous
studies have shown that this type of intervention reduces stress and improves health [
33
,
34
].
Additionally, the experimental group participated in local tourism activities near Taean,
including walking along the coast, visiting the Cheongsan Arboretum, attending the Taean
Light Festival, and experiencing tidal flats. Local tours were conducted under researcher
supervision to ensure participant safety.
The experimental and control groups both performed core exercise interventions. The
50 min sessions included a warm-up, main exercise, and cool-down. The warm-up and
cool-down exercises focused on stretching and improving mobility, while the main exercise,
lasting 30 min, involved core muscle function training, including abdominal breathing,
bridge exercises, dead bug exercises, plank exercises, bird dog exercises, and side bridge
exercises. Participants began with static exercises (e.g., abdominal breathing, planks) and
progressed to dynamic exercises (e.g., bird dogs, side bridges). Each exercise was performed
for 3 sets of 10 repetitions and was tailored to the individual abilities of participants. The
difficulty was gradually increased as participants adapted to the exercises.
Medicina 2025,61, 172 6 of 15
Table 1. Schedule of the experimental group.
Time Day 1 Day 2 Day 3 Day 4 Day 5
07:00–08:00 Coastal walk Coastal walk Coastal walk Coastal walk
08:00–09:00 Breakfast Breakfast Breakfast Breakfast
09:00–10:00 CORE exercise CORE exercise CORE exercise CORE exercise
10:00–11:00 Mindfulness
meditation
Mindfulness
meditation
Mindfulness
meditation
Mindfulness
meditation
11:00–12:00 Break time Break time Break time Post-measurement
12:00–13:00 Lunch Lunch Lunch
13:00–14:00 Orientation CORE exercise CORE exercise CORE exercise Lunch
14:00–15:00 Pre-measurement Nordic walking
Visiting
Cheongsan
Arboretum Tideland activity Check-out
15:00–16:00
16:00–17:00 CORE exercise Heated peat
pack treatment
Heated peat
pack treatment
Heated peat
pack treatment
17:00–18:00 Heated peat
pack treatment Break time Break time Dinner
18:00–19:00 Dinner Dinner Dinner Visiting Taean
Light Festival
19:00–20:00 Individual marine
healing activities
Individual marine
healing activities
Individual marine
healing activities
20:00–21:00 Washing and personal care
21:00–22:00 Sleeping
The control group received the same core exercises as the experimental group but did
not participate in heated peat packs, mindfulness meditation, or local tourism.
To minimize potential biases related to human or seasonal factors, the same research
team administered the interventions to both the experimental and control groups, ensuring
consistency, with a one-week interval between the groups.
2.7. Outcome Measures
2.7.1. Primary Outcome (Pain, Pressure Pain Threshold, Properties of Muscles, Disability)
The Visual Analog Scale (VAS) was used to determine participants’ pain levels. Partic-
ipants were instructed to draw a straight line perpendicular to a line marked with 0 (no
pain) and 10 (most severe pain imaginable) to indicate their level of back pain at rest and
during activities such as housework or daily tasks. The test–retest reliability of this tool
was found to be 0.97 [35].
The threshold for pressure-induced pain was measured using a digital algometer
(PAIN TEST
TM
FPIX, Greenwich, CT, USA). While lying prone in a comfortable position,
participants indicated when they first experienced discomfort or pain as the evaluator
applied increasing pressure 2 cm lateral to the spinous processes of the L3 and L5 vertebrae.
The intra-rater reliability for this tool was 0.932 [36].
Muscle tone and stiffness were assessed using the Myoton (Myoton AS, Tallinn,
Estonia) while participants lay prone. The tool was applied 2 cm lateral to the spinous
processes of the L3 and L5 vertebrae. The intra-rater reliability of this tool was above
0.750 [37].
The Oswestry Disability Index (ODI) was used to evaluate functional disability due
to back pain. This self-administered questionnaire consists of 10 questions scored on a
5-point scale. The total score is multiplied by 2 to generate a percentage, with higher scores
indicating greater disability. The Cronbach’s αvalue of this tool was 0.73 [38].
Medicina 2025,61, 172 7 of 15
2.7.2. Secondary Outcome (Lower Extremity Function, Balance, Gait, Depression)
Lower extremity function was evaluated using the Short Physical Performance Battery
(SPPB), which includes static balance, walking speed, and chair rise tests. The test–retest
reliability of this tool was over 0.83 [39].
Balance ability was assessed using the Accusway force plate (Advanced Mechanical
Technology, Inc., Watertown, MA, USA) by measuring shifts in the center of gravity during
standing with eyes open and closed. Participants stood with their heels approximately
9 cm apart and arms crossed in front of their chest and focused on an X-shaped target at
eye level. The reliability of this tool was above 0.7 [40].
Gait ability was measured using the GAITRite walkway (CIR Systems Inc., Franklin,
NJ, USA). Spatiotemporal walking variables were calculated from center of pressure (COP)
data obtained using sensors embedded in the mat. Measurements were conducted in a
disturbance-free environment, with participants instructed to walk at a comfortable speed.
The reliability of this tool was above 0.92 [41].
Depression severity was assessed using the Beck Depression Inventory (BDI), a self-
report questionnaire with 21 items. Scores were categorized as follows: 0–9 (no or minimal
depression), 10–18 (mild to moderate depression), 19–29 (moderate to severe depression),
and 30–63 (very severe depression). The Cronbach’s αvalue of this tool was 0.89 [42].
2.8. Statistical Analysis
Data collected in this study were analyzed using SPSS version 25.0 (IBM Corp., Ar-
monk, NY, USA). The normality of the data was confirmed using the Shapiro–Wilk test.
Homogeneity between groups was assessed using independent t-tests and chi-squared
(
χ2
) tests. Differences within and between groups were analyzed using mixed repeated-
measures analysis of variance (ANOVA). Tukey’s HSD test was used for post hoc testing.
Statistical significance was set at α= 0.05.
3. Results
3.1. General Characteristics of Participants
All participants completed the program without dropping out. The demographic
characteristics of the participants in this study are as follows (Table 2).
Table 2. General characteristics.
Variables G1 G2 p-Value
Age (y) a68.91 ±5.07 68.57 ±5.05 0.817
Sex (M/F) b7/16 8/15 0.753
Height (cm) a158.24 ±7.65 158.46 ±7.62 0.924
Weight (kg) a62.23 ±9.69 61.89 ±9.43 0.905
BMI (kg/m2)a24.80 ±3.00 24.61 ±2.92 0.823
Percent body fat (%) a33.24 ±6.82 34.26 ±6.20 0.599
Skeletal muscle mass (kg) a22.38 ±4.58 24.25 ±5.05 0.196
a
Values are expressed as the mean
±
SD.
b
Values are expressed as numbers.
Independent t-test used for
comparison of continuous variables.
Chi-squared test used for comparison of categorical variables. BMI, body
mass index.
3.2. Primary Outcomes
The primary outcomes in this study were as follows (Table 3).
Medicina 2025,61, 172 8 of 15
Table 3. Primary outcomes.
Variables Group Pre-Test Post-Test p-Value
ANOVA
η2p
Mean ±SD Mean ±SD
PPT
L3
G1 6.09 ±2.72 7.76 ±2.70 <0.001
G2 6.12 ±2.61 6.19 ±2.17 0.756 <0.001 0.34
p-value 0.968 0.035
L5
G1 5.73 ±3.10 6.91 ±3.16 0.030
G2 6.05 ±3.16 5.64 ±2.32 0.305 0.017 0.12
p-value 0.725 0.127
VAS
Resting pain G1 4.11 ±1.75 1.17 ±1.45 <0.001
G2 3.89 ±1.70 3.40 ±1.42 0.017 <0.001 0.39
p-value 0.663 <0.001
Movement pain G1 5.74 ±1.98 1.68 ±1.61 <0.001
G2 5.47 ±1.99 4.74 ±1.61 0.010 <0.001 0.38
p-value 0.645 <0.001
Myoton
L3 Tone
G1 19.00 ±4.24 17.19 ±2.30 0.015
G2 19.62 ±4.32 19.34 ±4.02 0.286 0.042 0.09
p-value 0.625 0.031
L3 Stiffness
G1 402.48 ±112.61 357.00 ±61.51 0.017
G2 377.79 ±90.84 376.45 ±91.35 0.372 0.016 0.12
p-value 0.418 0.402
L5 Tone
G1 17.19 ±2.69 16.23 ±4.04 0.045
G2 16.30 ±3.06 16.57 ±3.22 0.438 0.036 0.10
p-value 0.300 0.751
L5 Stiffness
G1 374.74 ±93.14 350.87 ±89.78 0.058
G2 340.83 ±95.67 341.87 ±98.30 0.900 0.092 0.06
p-value 0.230 0.747
ODI
G1 42.06 ±12.61 24.72 ±9.81 <0.001
G2 43.67 ±13.84 40.72 ±11.37 0.141 <0.001 0.28
p-value 0.682 <0.001
η2p, partial eta squared. PPT, pain pressure threshold; L, lumbar spine; VAS, visual analog scale; ODI, Oswestry
Disability Index.
3.2.1. Pain
Pain at rest and pain during movement showed significant improvement in both the
experimental and control groups after the intervention, and in particular, the experimental
group showed greater improvement than the control group (p< 0.05).
3.2.2. Pressure Pain Threshold
The pressure pain threshold at L3 and L5 levels was significantly improved in the
experimental group after intervention (p< 0.05). On the other hand, no significant changes
were observed in the control group (p> 0.05).
3.2.3. Properties of Muscles
Among muscle properties, tone and stiffness at the L3 level and tone at the L5 level
were significantly improved in the experimental group after intervention (p< 0.05). How-
ever, in the case of stiffness at the L5 level, no significant improvement was observed
in both the experimental and control groups (p> 0.05). There was no change in muscle
properties in the control group (p> 0.05).
3.2.4. Disability
In the case of disability level, significant improvement was observed in the experimen-
tal group after intervention (p< 0.05). There was no significant improvement in the control
group (p> 0.05).
Medicina 2025,61, 172 9 of 15
3.3. Secondary Outcomes
The secondary outcomes in this study were as follows (Table 4).
Table 4. Secondary outcomes.
Variables Group Pre-Test Post-Test p-Value
ANOVA
η2p
Mean ±SD Mean ±SD
SPPB
G1 9.46 ±1.74 10.96 ±1.11 <0.001
G2 9.63 ±1.37 9.72 ±1.36 0.539 <0.001 0.35
p-value 0.709 0.002
BDI
G1 23.61 ±12.36 6.74 ±4.71 <0.001
G2 22.14 ±11.56 21.90 ±11.81 0.336 <0.001 0.47
p-value 0.679 <0.001
Balance ability
Sway area (cm2)
G1 289.55 ±230.78 208.80 ±143.03 0.046
G2 303.28 ±238.40 316.46 ±267.96 0.182 0.021 0.11
p-value 0.844 0.096
Sway velocity
(cm/s)
G1 15.87 ±8.24 13.96 ±7.16 0.242
G2 16.71 ±8.71 16.80 ±7.94 0.901 0.256 0.03
p-value 0.738 0.209
Gait ability
Velocity
(cm/s)
G1 110.70 ±13.09 122.84 ±12.67 <0.001
G2 104.56 ±14.16 106.86 ±26.45 0.636 0.065 0.08
p-value 0.134 0.012
Cadence
(step/min)
G1 109.27 ±6.91 113.41 ±7.63 <0.001
G2 103.21 ±9.77 100.24 ±15.86 0.355 0.036 0.10
p-value 0.019 <0.001
Step length
(cm)
G1 60.68 ±6.87 64.24 ±8.58 0.020
G2 64.01 ±8.57 63.97 ±7.34 0.971 0.048 0.09
p-value 0.153 0.911
η2p, partial eta squared; SPPB, Short Physical Performance Battery; BDI, Beck Depression Inventory.
3.3.1. Lower Extremity Function
Lower extremity function showed significant improvement in the experimental group
after intervention (p< 0.05). No significant changes were observed in the control group
(p> 0.05).
3.3.2. Balance
In terms of balance ability, the sway area showed significant improvement in the
experimental group after intervention (p< 0.05). However, in the case of sway velocity, no
significant changes were observed in all groups (p> 0.05).
3.3.3. Gait
The experimental group showed significant improvement in all variables of walking
ability after intervention (p< 0.05). The control group showed no significant changes
(p> 0.05).
3.3.4. Depression
There was significant improvement in the level of depression in the experimental
group after intervention (p< 0.05). There was no significant change in the control group
(p> 0.05).
4. Discussion
In this study, we found that a natural healing program using Taean’s marine resources
was effective in reducing pain, decreasing muscle tension, and improving daily living skills
in patients with non-specific chronic low back pain (NSLBP). These results suggest that
marine healing programs can contribute to improving both physical and mental health.
Medicina 2025,61, 172 10 of 15
Visiting natural environments can play an important role in pain management, as it
has been shown to increase the pain threshold and tolerance [
43
]. The results of this study
are consistent with previous findings that demonstrated positive effects of meditation and
exercise in marine areas on various health aspects, including pain intensity, tactile spatial
accuracy, balance, overall quality of life, and depression scores [44].
This study suggests that the effects of the marine healing program on pain reduction
and functional improvement in patients with non-specific chronic low back pain (NSCLBP)
may be attributed to its psychological and mental benefits. Chronic pain patients often
experience anxiety, depression, and cognitive impairments, which are associated with struc-
tural and functional changes in the brain, particularly in gray matter volume [
45
]. These
neurological changes affect regions involved in pain processing, emotional regulation, and
cognition. Notably, individuals with chronic low back pain (CLBP) have been reported to
struggle with emotional processing [
20
,
21
]. Previous studies have highlighted the effective-
ness of psychosocial approaches such as CBT, yoga, and relaxation techniques in reducing
pain perception and improving overall quality of life for chronic pain
patients [46,47].
En-
vironmental factors, lifestyle modifications, and mind–body practices such as yoga and
meditation have been shown to mitigate pain perception and counteract brain changes
associated with chronic pain [
45
]. Furthermore, nature-based meditation has demonstrated
significant effects in enhancing psychological and physiological well-being, fostering inter-
personal relationships, increasing positive emotions, and reducing negative emotions [
48
].
Marine healing programs, in particular, promote emotional stability and alleviate stress,
which may contribute to reducing low back pain and improving functional outcomes [
49
].
These interventions address the psychological factors associated with pain chronicity, sim-
ilar to the benefits observed in the marine healing program. Moreover, the program’s
unique combination of peat therapy, mindfulness meditation, and natural environmental
exposure enhances emotional stability and reduces stress, contributing to pain alleviation
and functional improvement. Taean’s marine resources, including coastal scenery and
fresh air, further amplify these benefits, aligning with findings that natural environments
positively influence physical and mental health [
50
52
]. The findings of this study support
the conclusion that marine healing programs enhance participants’ emotional processing
abilities, thereby contributing to the reduction in low back pain.
Marine therapy, encompassing marine-derived treatments such as thalassotherapy
and algotherapy, has demonstrated substantial benefits in managing various diseases due
to the bioactive compounds in marine resources. Thalassotherapy, involving seawater,
sand, and marine products, is known for its anti-inflammatory and immunomodulatory
effects, particularly in dermatological conditions like psoriasis, eczema, and vitiligo, as
well as rheumatologic disorders such as fibromyalgia and rheumatoid arthritis [
53
]. Al-
gae, central to algotherapy, contain high levels of vitamins, amino acids, and minerals
that aid in cardiovascular health, metabolic regulation, and skin repair [
54
]. Seawater’s
mineral-rich composition further supports wound healing, antioxidant activity, and disease
management [55].
Core exercises are widely recognized for their ability to strengthen trunk muscles
and enhance lumbar stability, which can contribute to pain relief and improved spinal
support [
56
,
57
]. By strengthening the core, these exercises help alleviate strain on the spine
and promote a better balance of the muscles surrounding the spinal column [
58
]. As a result,
core exercises may have a positive impact on improving individuals’ ability to carry out
daily activities by reducing pain, improving static balance, and enhancing lower extremity
function and walking ability. In the program conducted as part of this study, participants
engaged in core exercises daily throughout the intervention period. Although the program
lasted only five days, the benefits of these exercises likely contributed to the reduction in
Medicina 2025,61, 172 11 of 15
participants’ low back pain. Although muscle strengthening typically requires sustained
exercise programs over weeks or months, short-term interventions can transiently reduce
muscle tone and stiffness through increased circulation and neuromuscular activation [
24
].
This aligns with the observed improvements in muscle tone after 5 days of basic exercises.
The results of this study demonstrate the significant potential of Taean’s marine
resources for enhancing both physical and mental health. The natural environment of
this region offers benefits such as reducing inflammation and pain, while the marine ele-
ments, in combination with exercise and healing programs, contribute to improved mental
well-being [
25
27
]. Previous studies have similarly highlighted the benefits of natural
environments for alleviating depression and hypertension, with sunlight exposure playing
a particularly effective role in improving depressive symptoms [
28
]. These elements of
the marine environment can play a vital role in chronic pain management and preventive
healthcare. Taean’s marine resource healing program, by harnessing these natural elements,
presents a promising approach to health promotion. Moreover, this study aligns with
the principles outlined in the latest clinical practice guidelines, including those from the
American College of Physicians (ACP) and the National Institute for Health and Care
Excellence (NICE) [
7
,
59
]. By integrating evidence-based exercise therapy with innovative
interventions like marine healing programs, the findings highlight the potential for ad-
vancing noninvasive and patient-centered care for chronic low back pain. These results
reinforce the conclusion that Taean’s marine resource healing program can significantly
contribute to health promotion. While this study clarified the various positive effects of
the marine healing program on patients with non-specific chronic low back pain, several
limitations warrant caution in generalizing the findings. First, the study involved a limited
number of participants, and the sample was drawn from a specific region, restricting the
generalizability of the results. Future studies should aim to include a larger and more
diverse population to enhance the scope and applicability of the findings. Second, the
short duration of the study (4 nights and 5 days) limits the ability to comprehensively
assess the program’s long-term benefits. Longitudinal studies with extended follow-up
periods are essential, particularly to determine the persistence of physical gains over time
and to evaluate the broader effects on functional outcomes. Third, the pressure pain
threshold (PPT) measurements were limited to symptomatic areas (L3 and L5). While
this approach allowed for a focused evaluation of the intervention’s localized effects on
pain sensitivity and muscle properties, it did not account for potential systemic effects
that could be observed by assessing PPT at distant, asymptomatic regions. Future studies
should consider incorporating PPT measurements at both symptomatic and distant sites
to provide a more comprehensive understanding of the intervention’s impact. Finally,
comparative studies with other healing programs are needed to assess the relative effects
of the marine healing program. The synergistic effects of the marine healing program and
exercise likely contributed to the observed outcomes. While the psychological benefits
of the marine environment, such as stress reduction and emotional regulation, enhance
physical recovery, further studies are needed to evaluate the standalone efficacy of the
marine healing program compared to exercise alone. Addressing these limitations through
more comprehensive and rigorous study designs will allow for a more precise evaluation
of the program’s effectiveness.
5. Conclusions
A marine healing program utilizing Taean’s marine resources is effective in reduc-
ing pain, alleviating muscle tension, and improving daily living skills in patients with
non-specific chronic low back pain (NSLBP). This integrative approach addresses the
limitations of conventional treatments by incorporating natural environmental benefits,
Medicina 2025,61, 172 12 of 15
physical therapy, and mindfulness practices. Future studies should focus on evaluating the
program’s long-term effects and comparing its efficacy with other established interventions.
Expanding the participant pool and diversifying demographics will also provide more
generalizable results.
Author Contributions: Conceptualization, H.-Y.C.; methodology, J.-E.B. and S.-H.K.; formal analysis,
S.-H.K.; investigation, H.-J.S.; data curation, J.-E.B. and H.-J.S.; writing—original draft preparation,
J.-E.B., S.-H.K. and H.-Y.C.; writing—review and editing, H.-Y.C.; visualization, J.-E.B.; supervision,
H.-Y.C.; funding acquisition, H.-J.S. and H.-Y.C. All authors have read and agreed to the published
version of the manuscript.
Funding: This work was supported by the National Research Foundation of Korea (NRF) grant
funded by the Korea government (MSIT) (RS-2022-NR074290 and RS-2023-00239573).
Institutional Review Board Statement: This study was conducted in accordance with the Declaration
of Helsinki and approved by the Institutional Review Board of Gachon University (1044396-202108-
HR-181-01 and 9 October 2021). The study was registered with the Clinical Research Information
Service No. KCT0009103.
Informed Consent Statement: Informed consent was obtained from all subjects involved in the study.
Data Availability Statement: The data used in this study are available from the corresponding author
upon request but are not publicly accessible, due to ethical restrictions.
Conflicts of Interest: The authors declare no conflicts of interest.
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The HEALTHYBACK trial is based on a multimodal intervention to determine the effectiveness of a supervised physical exercise, mindfulness, behaviour change and pain neuroscience education programme on several health variables in individuals with chronic primary low back pain (CPLBP). The study will be a randomised controlled trial among 70 individuals diagnosed with CPLBP (aged 18–65 years). The intervention will be conducted in person within a hospital setting for 16 weeks and comprises a first phase (16 sessions supervised physical exercise (2 days/week, 45 min/session), mindfulness (1 day/week, 2.5 hours/session), behaviour change (daily/24 hours via a wrist-worn activity prompting device) and pain neuroscience education (1 day/biweekly, 2 hours/session)) and a second phase (16 sessions functional full-body muscle strengthening exercise, 3 days/week, 50 min/session). The primary outcomes will include perceived acute pain, pain pressure threshold, conditioned pain modulation, temporal summation of pain and disability due to pain. Secondary measures will include physical fitness, body composition, gait parameters, device-measured physical activity and sedentary behaviour, haematological profile, self-reported sedentary behaviour, quality of life, pain catastrophising, mental health, sleep duration and quality, and symptoms related to central sensitisation. The groups will undergo pretest (before the intervention), post-test (after each phase of the intervention) and retest (at a 6-week detraining period after the intervention) measurements. The results will determine the effectiveness of multidimensional interventions on several health parameters in individuals with CPLBP. They will provide knowledge for pain management and functioning in affected individuals, which might diminish the need for primary healthcare services. Trial registration number: NCT06114264 .
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Objective Chronic low back pain (CLBP) is a prevalent health condition worldwide. Several therapeutic interventions aim to improve CLBP. Pain Neuroscience Education (PNE) helps patients better understand their pain from biological and physiological perspectives, which clinicians use to reduce pain and disability in patients with chronic musculoskeletal conditions. Neuromuscular exercises (NMS) are also treatments adopted in CLBP. This study will investigate whether PNE combined with an NMS program improves pain, functional and psychological outcomes more than NMS alone in patients with CLBP. Methods In this single-blind randomized controlled trial, 60 patients (male and female; age range, 30–60 years) diagnosed with CLBP will be randomly assigned to one of the following groups: (1) PNE plus NMS (n = 30; 24 sessions of PNE plus NMS in a total of 8 weeks, 3 each week), and (2) NMS alone (n = 30; 24 sessions of NMS sessions in a total of 8 weeks, 3 each week). Outcome assessors will be blinded to the group allocation. The primary outcome will be pain. Secondary outcomes will be disability, fear-avoidance beliefs about work and physical activity, self-efficacy, exercise anxiety, and kinesiophobia. Outcomes will be assessed at baseline, after 8 weeks of intervention, and 6 months post-intervention. Discussion The findings of this RCT will help shed light on new treatment strategies to address the biopsychosocial dimensions of CLBP. The study protocol will be conducted in a clinical setting, offering the opportunity for future implementation in healthcare systems. Moreover, it will help clarify whether a combined treatment (PNE with NMS) is more effective than NMS alone for improving pain, functional and psychological outcomes in CLBP. Trial registration Study registration: The study was prospectively registered in the Iranian Registry of Clinical Trials—IRCT20190427043384N2 (https://www.irct.ir/trial/69146). Registered on March 17, 2023.
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Background The close relationship between pain and mental health problems is well-known, and psychological intervention can provide an effective alternative to medication-based pain relief. However, previous studies on the connection between pain and psychological problems, the findings thus far have been inconclusive, limiting the potential for translating psychological interventions into clinical practice. To complement the gap, this study utilized genetic data and Mendelian randomization (MR) to examine the potential relationship between pain in different parts and common mental disorders. Methods Based on the instrumental variables selected from the Genome-wide association study summary statistics of localized pain and mental disorders, we conducted bidirectional two-sample MR analyses to infer bidirectional causal associations between pain and mental disorders. The inverse-variance weighted MR method and MR-Egger were used as the primary statistical method according to the horizontal pleiotropy and heterogeneity level. We reported the odds ratio to infer the causal effect between pain and mental disorders. F statistic was calculated to measure the statistical efficacy of the analyses. Results Insomnia is causally related to the genetic susceptibility of multisite pain including head (OR = 1.09, 95% CI: 1.06–1.12), neck/shoulder (OR = 1.12, 95% CI: 1.07–1.16), back (OR = 1.12, 95% CI: 1.07–1.18) and hip (OR = 1.08, 95% CI: 1.05–1.10). Reversely, headache (OR = 1.14, 95% CI: 1.05–1.24), neck/shoulder pain (OR = 1.95, 95% CI: 1.03–3.68), back pain (OR = 1.40, 95% CI: 1.22–1.60), and hip pain (OR = 2.29, 95% CI: 1.18–4.45) promote the genetic liability of insomnia. Depression is strongly associated with the predisposition of multisite pain including headache (OR = 1.28, 95% CI: 1.08–1.52), neck/shoulder pain (OR = 1.32, 95% CI: 1.16–1.50), back pain (OR = 1.35, 95% CI: 1.10–1.66) and stomach/abdominal pain (OR = 1.14, 95% CI: 1.05–1.25), while headache (OR = 1.06, 95% CI: 1.03–1.08), neck/shoulder (OR = 1.09, 95% CI: 1.01–1.17), back (OR = 1.08, 95% CI: 1.03–1.14), and stomach/abdominal pain (OR = 1.19, 95% CI: 1.11–1.26) are predisposing factors for depression. Additionally, insomnia is associated with the predisposition of facial, stomach/abdominal, and knee pain, anxiety was associated with the predisposition of neck/shoulder and back pain, while the susceptibilities of hip and facial pain are influenced by depression, but these associations were unidirectional. Conclusions Our results enhance the understanding of the complex interplay between pain and mental health and highlight the importance of a holistic approach to pain management that addresses both physical and psychological factors.
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Background Low back pain is highly prevalent and the main cause of years lived with disability (YLDs). We present the most up-to-date global, regional, and national data on prevalence and YLDs for low back pain from the Global Burden of Diseases, Injuries, and Risk Factors Study 2021. Methods Population-based studies from 1980 to 2019 identified in a systematic review, international surveys, US medical claims data, and dataset contributions by collaborators were used to estimate the prevalence and YLDs for low back pain from 1990 to 2020, for 204 countries and territories. Low back pain was defined as pain between the 12th ribs and the gluteal folds that lasted a day or more; input data using alternative definitions were adjusted in a network meta-regression analysis. Nested Bayesian meta-regression models were used to estimate prevalence and YLDs by age, sex, year, and location. Prevalence was projected to 2050 by running a regression on prevalence rates using Socio-demographic Index as a predictor, then multiplying them by projected population estimates. Findings In 2020, low back pain affected 619 million (95% uncertainty interval 554–694) people globally, with a projection of 843 million (759–933) prevalent cases by 2050. In 2020, the global age-standardised rate of YLDs was 832 per 100 000 (578–1070). Between 1990 and 2020, age-standardised rates of prevalence and YLDs decreased by 10·4% (10·9–10·0) and 10·5% (11·1–10·0), respectively. A total of 38·8% (28·7–47·0) of YLDs were attributed to occupational factors, smoking, and high BMI. Interpretation Low back pain remains the leading cause of YLDs globally, and in 2020, there were more than half a billion prevalent cases of low back pain worldwide. While age-standardised rates have decreased modestly over the past three decades, it is projected that globally in 2050, more than 800 million people will have low back pain. Challenges persist in obtaining primary country-level data on low back pain, and there is an urgent need for more high-quality, primary, country-level data on both prevalence and severity distributions to improve accuracy and monitor change.
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Background Low back pain affects millions of people worldwide and can be a difficult condition to manage clinically. Many cases do not have a discernable etiology, further increasing the complexity of finding an effective intervention. Core stabilization exercises (CSE) strengthen the musculature that provides stability to the spine and show promising outcomes. Purpose To examine the efficacy of CSE exercises in the treatment of NSLBP in adult patients. Study Selection Studies were included if they had patients diagnosed with NSLBP, used CSE as a treatment for NSLBP, and were a clinical trial. Exclusion criteria were studies that did not utilize an objective pain scale, patients who had a specific diagnosed pathology contributing to the NSLBP or received treatment for their NSLBP within the prior six months. Methods The literature was systematically searched in the PubMed, Sports Medicine & Education Index, and CINHAL databases, using the search terms core stabilization, low back pain, and exercise. The initial search yielded 229 articles and was refined using search terms ‘NOT analysis’ in order to target randomized control trials and exclude meta-analyses to narrow the search. Full-text of the articles were assessed for eligibility by utilizing inclusion and exclusion criteria that were included in this review. Articles were assessed for quality using the PEDro scale and relevant data were extracted. Results Five moderate-quality studies (PEDRO range: 5-8) support CSE is an effective method to decrease pain, improve functionality, and increase core strength in patients with NSLBP. Although there are other commonly used methods to treating NSLBP, CSE have shown to be a beneficial method to treating NSLBP. Conclusion Grade B evidence suggests core stabilization exercises can be considered a favorable method for treating pain in patients with NSLBP. Level of Evidence 1b
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Female caregivers of people with disabilities are burdened physically and mentally. To improve these symptoms, an intervention that is easy to apply and has fewer side effects, such as natural healing, has been proposed, but the effect of healing using marine resources is unclear until now. The purpose of this study is to investigate the effect of meditation accompanied with stabilization exercise in the marine region on the improvement of pain, tactile sense, muscle characteristics, muscle strength, balance, quality of life, and depression in female caregivers of people with severe physical disabilities. Twenty-four female family caregivers were recruited and were randomly assigned to the marine therapy group (MTG, n = 12) and the control group (CG, n = 12). Both groups performed the same meditation (35 min) and stabilization exercise (25 min) twice a day for 3 nights and 4 days per session (total 8 sessions). The MTG performed these in the marine region, whereas the CG performed the interventions in the urban region. Pain (pain intensity and pain pressure threshold), tactile sense (tactile spatial acuity), muscle characteristics (stiffness, elasticity), muscle strength (hand and pinch grip strength), balance, quality of life, and depression were measured before and after the intervention and 4 weeks after the intervention. Both groups showed significant improvements in pain intensity (resting pain: f(2) = 72.719, p < 0.001; movement pain: f(2) = 24.952, p < 0.001), muscle strength (right pinch grip: f(2) = 15.265, p < 0.001), and depression (f(2) = 13.312, p < 0.001), while tactile spatial acuity (TSA) (upper part: f(2) = 14.460, p < 0.001; lower part: f(2) = 7.672, p = 0.002), dynamic balance (f(2) = 4.196, p = 0.024), and quality of life (overall quality of life & general health: f(2) = 5.443, p = 0.009; physical health: f(2) = 13.991, p < 0.001; psychological: f(2) = 9.946, p < 0.001; environmental: f(2) = 20.004, p < 0.001; total: f(2) = 11.958, p < 0.001) were significantly improved only in MTG. There was no significant change in pain pressure threshold (upper trapezius (UT): f(2) = 0.765, p = 0.473; levator scapula (LS): f(2) = 0.213, p = 0.809; splenius capitis (SC): f(2) = 0.186, p = 0.831) and muscle characteristics (UT stiffness: f(2) = 1.486, p = 0.241; UT elasticity: f(2) = 0.358, p = 0.702; LS stiffness: f(2) = 2.440, p = 0.102; LS elasticity: f(2) = 0.544, p = 0.585) in both groups. In comparison between groups, the MTG showed a significant difference in sensory function compared to the CG (resting pain: f(2) = 10.487, p = 0.005; lower part: f(2) = 5.341, p = 0.034 in TSA). Our findings suggest that meditation combined with stabilization exercise improved pain, muscle strength, and depression of female caregivers. In particular, greater benefits on tactile sense, balance, and quality of life were found in performing these in the marine region compared to the urban region.
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The therapeutic use of seawater and sea resources dates back to ancient times. However, there is a need for in-depth study and summarization of the available clinical possibilities of modern thalassotherapy. Contact with sea water, sand and/or healing mud, methodical exposure to the sunlight, as well as environmental factors (atmosphere, temperature, humidity, wind, air pressure), are the basis of today‘s treatment procedures suitable for both children and geriatric patients. Due to the unique chemical composition of seawater, anti-inflammatory and immunomodulatory effects on the human body have been reported. Even short-term treatment by the sea can be used to relieve dermatological conditions such as psoriasis, atopic dermatitis, vitiligo, etc . In combination with physical exercises, thalassotherapy improves the symptoms of rheumatoid arthritis, rheumatic fibromyalgia, ankylosing spondylitis, psoriatic arthritis, and non-inflammatory joint processes. Separately, sea treatment is used to improve ventilatory performance in patients with bronchial asthma. The possibility of additional treatment for chronic inflammatory gynecological diseases, ovarian failure, neurovegetative disorders, menopausal symptoms and others has also been reported. The growing interest in natural treatments in recent years is an argument for conducting additional and even larger studies to explore the possibilities of modern thalassotherapy. Moreover, clinical data from recent years reinforce the potential for the development of maritime health tourism in Bulgaria.
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Background context Currently, there are no published studies that compare non-pharmacological, pharmacological and invasive treatments for chronic low back pain in adults and provide summary statistics for benefits and harms. Purpose The aim of this review was to compare the benefits and harms of treatments for the management of chronic low back pain without radiculopathy and to report the findings in a format that facilitates direct comparison (Benefit-Harm Scale: level 1 to 7). Design Systematic review and meta-analysis of randomized controlled trials, including trial registries, from electronic databases up to 23rd May 2022. Patient sample Adults with non-specific chronic low back pain, excluding radicular pain in any clinical setting. Outcome measures Comparison of pain at immediate-term (≤2 weeks) and short-term (>2 weeks to ≤12 weeks) and serious adverse events using the Benefit-Harm Scale (level 1 to 7). Methods This was a registered systematic review and meta-analysis of randomized controlled trials. Interventions included non-pharmacological (acupuncture, spinal manipulation only), pharmacological and invasive treatments compared to placebo. Best evidence criteria was used. Two independent reviewers conducted eligibility assessment, data extraction and quality appraisal. Results The search retrieved 17,362 records. Three studies provided data on the benefits of interventions, and 30 provided data on harms. Studies included interventions of acupuncture (n = 8); manipulation (n = 2); pharmacological therapies (n = 9), including NSAIDs and opioid analgesics; surgery (n = 8); and epidural corticosteroid injections (n = 3). Acupuncture (standardized mean difference (SMD) -0.51, 95%CI -0.88 to -0.14, n = 1 trial, moderate quality of evidence, benefit rating of 3) and manipulation (SMD -0.39 (96%CI -0.56 to -0.21, n = 2 trials, moderate quality of evidence, benefit rating of 5) were effective in reducing pain intensity compared to sham. The benefit of the other interventions was scored as uncertain due to not being effective, statistical heterogeneity preventing pooling of effect sizes, or the absence of relevant trials. The harms level warnings were at the lowest (e.g. indicating rarer risk of events) for acupuncture, spinal manipulation, NSAIDs, combination ingredient opioids, and steroid injections, while they were higher for single ingredient opioid analgesics (level 4) and surgery (level 6). Conclusions There is uncertainty about the benefits and harms of all the interventions reviewed due to the lack of trials conducted in patients with chronic non-specific low back pain without radiculopathy. From the limited trials conducted, non-pharmacological interventions of acupuncture and spinal manipulation provide safer benefits than pharmacological or invasive interventions. However, more research is needed. There were high harms ratings for opioids and surgery. Registration This review was registered on the International Prospective Register of Systematic Reviews.