Naturopathic Care for Chronic Low Back Pain: A Randomized Trial

Article (PDF Available)inPLoS ONE 2(9):e919 · September 2007with41 Reads
DOI: 10.1371/journal.pone.0000919 · Source: PubMed
Abstract
Chronic low back pain represents a substantial cost to employers through benefits coverage and days missed due to incapacity. We sought to explore the effectiveness of Naturopathic care on chronic low back pain. This study was a randomized clinical trial. We randomized 75 postal employees with low back pain of longer than six weeks duration to receive Naturopathic care (n = 39) or standardized physiotherapy (n = 36) over a period of 12 weeks. The study was conducted in clinics on-site in postal outlets. Participants in the Naturopathic care group received dietary counseling, deep breathing relaxation techniques and acupuncture. The control intervention received education and instruction on physiotherapy exercises using an approved education booklet. We measured low back pain using the Oswestry disability questionnaire as the primary outcome measure, and quality of life using the SF-36 in addition to low back range of motion, weight loss, and Body Mass Index as secondary outcomes. Sixty-nine participants (92%) completed eight weeks or greater of the trial. Participants in the Naturopathic care group reported significantly lower back pain (-6.89, 95% CI. -9.23 to -3.54, p = <0.0001) as measured by the Oswestry questionnaire. Quality of life was also significantly improved in the group receiving Naturopathic care in all domains except for vitality. Differences for the aggregate physical component of the SF-36 was 8.47 (95% CI, 5.05 to 11.87, p = <0.0001) and for the aggregate mental component was 7.0 (95% CI, 2.25 to 11.75, p = 0.0045). All secondary outcomes were also significantly improved in the group receiving Naturopathic care: spinal flexion (p<0.0001), weight-loss (p = 0.0052) and Body Mass Index (-0.52, 95% CI, -0.96 to -0.08, p = 0.01). Naturopathic care provided significantly greater improvement than physiotherapy advice for patients with chronic low back pain. Controlled-Trials.com ISRCTN41920953.
Naturopathic Care for Chronic Low Back Pain: A
Randomized Trial
Orest Szczurko
1
, Kieran Cooley
1
, Jason W. Busse
2
, Dugald Seely
1
, Bob Bernhardt
1
, Gordon H. Guyatt
2
, Qi Zhou
2
, Edward J. Mills
2
*
1 Division of Clinical Epidemiology, Canadian College of Naturopathic Medicine, Toronto, Ontario, Canada, 2 Department of Clinical Epidemiology and
Biostatistics, McMaster University, Hamilton, Ontario, Canada
Objective. Chronic low back pain represents a substantial cost to employers through benefits coverage and days missed due
to incapacity. We sought to explore the effectiveness of Naturopathic care on chronic low back pain. Methods. This study was
a randomized clinical trial. We randomized 75 postal employees with low back pain of longer than six weeks duration to
receive Naturopathic care (n = 39) or standardized physiotherapy (n = 36) over a period of 12 weeks. The study was conducted
in clinics on-site in postal outlets. Participants in the Naturopathic care group received dietary counseling, deep breathing
relaxation techniques and acupuncture. The control intervention received education and instruction on physiotherapy
exercises using an approved education booklet. We measured low back pain using the Oswestry disability questionnaire as the
primary outcome measure, and quality of life using the SF-36 in addition to low back range of motion, weight loss, and Body
Mass Index as secondary outcomes. Results. Sixty-nine participants (92%) completed eight weeks or greater of the trial.
Participants in the Naturopathic care group reported significantly lower back pain (26.89, 95% CI. 29.23 to 23.54,
p=,0.0001) as measured by the Oswestry questionnaire. Quality of life was also significantly improved in the group receiving
Naturopathic care in all domains except for vitality. Differences for the aggregate physical component of the SF-36 was 8.47
(95% CI, 5.05 to 11.87, p = ,0.0001) and for the aggregate mental component was 7.0 (95% CI, 2.25 to 11.75, p = 0.0045). All
secondary outcomes were also significantly improved in the group receiving Naturopathic care: spinal flexion (p,0.0001),
weight-loss (p = 0.0052) and Body Mass Index ( 20.52, 95% CI, 20.96 to 20.08, p = 0.01). Conclusions. Naturopathic care
provided significantly greater improvement than physiotherapy advice for patients with chronic low back pain. Trial
Registration. Controlled-Trials.com ISRCTN41920953
Citation: Szczurko O, Cooley K, Busse JW, Seely D, Bernhardt B, et al (2007) Naturopathic Care for Chronic Low Back Pain: A Randomized Trial. PLoS
ONE 2(9): e919. doi:10.1371/journal.pone.0000919
INTRODUCTION
Non-specific chronic low back pain is a common cause of activity
limitation in people younger than 45 years of age in developed
nations and is one of the most common reasons for accessing
physicians.[1] In addition to the burden of morbidity on individual
patients, chronic low back pain is one of the most costly disorders
for North American employers[2,3].
In North America, non-specific low back pain is the most
common reason for accessing complementary and alternative
medicine (CAM) providers[4] with as many as 43% of all back-
pain patients accessing CAM providers for care[5]. One
complementary therapy provider group that deals with many
back-pain patients as primary treatment providers are Naturo-
pathic physicians[6]. To date however, no clinical trial has been
conducted to evaluate the effectiveness of Naturopathic care for
the treatment of low back pain. To inform this issue, we conducted
a randomized controlled trial evaluating Naturopathic care versus
a standardized physiotherapy education regimen for chronic low
back pain.
METHODS
The protocol for this trial and supporting CONSORT checklist
are available as supporting information; see Checklist S1 and
Protocol S1.
Study Design
This study was conducted from March to September 2005 at the
Gateway Processing Plant of the Canada Post Corporation in
Mississauga, Ontario- the largest processing plant in Canada.
Canada Post employees who are members of the Canadian Union
of Postal Workers (CUPW) were recruited through poster
advertising at the plant and local depots. Interested employees
received an information package which included a sample
informed consent form, background information explaining the
purpose of the study, a description of the intended naturopathic
care, a question and answer sheet regarding study participation,
and contact information for study enrolment. Workers were
primarily from the Gateway plant, however a minority of the study
population were from other Canada Post facilities. Two licensed
Naturopathic physicians on site provided delivery of care (OS,
KC). The institutional review board of the Canadian College of
Naturopathic Medicine, in discussion with the Canada Post
Corporation and CUPW, approved the study protocol.
All potential study participants were required to provide
informed consent and to undergo a 1-hour assessment with
a medical physician. Participants were evaluated for non-specific
back pain through a thorough physical examination and
completion of the Oswestry Low Back Pain Disability Question-
naire and the Roland and Morris Low Disability Questionnaire.
Academic Editor: Peter Tugwell, University of Ottawa, Canada
Received July 5, 2007; Accepted July 13, 2007; Publis hed September 19, 2007
Copyright: ß 2007 Szcurko et al. This is an open-access article distributed under
the terms of the Creative Commons Attribution License, which permits
unrestricted use, distribution, and reproduction in any medium, provided the
original author and source are credited.
Funding: Funding was provided by the Canada Post Corporation and Canadian
Union of Postal Workers.
Competing Interests: The authors have declared that no competing interests
exist.
* To whom correspondence should be addressed. E-mail: millsej@mcmaster.ca
PLoS ONE | www.plosone.org 1 September 2007 | Issue 9 | e919
Participants had to have had low back pain of non-specific cause
for the preceding 6 weeks.
Participants were excluded if they could not comply with the
study protocol, had mild or no pain at the time of assessment,
a history of back surgery, sciatica, systemic or visceral causes of the
pain, osteoporosis, a vertebral fracture or dislocation, severe
neurological signs, spondylolisthesis, coagulation disorders, or
a severe concurrent illness. Participants were also excluded if they
were pregnant or were involved in claiming for compensation or
litigation because of back injury. Use of pain medications was not
a reason for exclusion.
This study was a randomized trial comparing Naturopathic care
to standardized physiotherapy advice. The treatment interventions
were planned for 12 weeks, with an option for control group
participants to receive naturopathic care at the end of week 12 .
The optional crossing-over period of treatment lasted 4 weeks.
After participants were considered eligible and baseline informa-
tion collected, they were randomized (1:1) using double-observed
coin-toss by OS and KC to either naturopathic care or an
educational booklet. Although the investigators and data analysts
were blinded to treatment allocation, it was not possible to mask
the interventions from the patients or the clinicians delivering care.
Treatment Groups
Naturopathic care Participants receiving naturopathic care
were seen twice per week to receive specific acupuncture treatment
for low back pain, for a total of 24 treatments over a period of
12 weeks. Specific points needled were: GV 3,4, BL 23, 25, 40
bilaterally. Each needle was inserted 0.5 cun and needles were
stimulated to achieve de qi (a dull sensation). Each needle was left
in place for 20 minutes. The needles used were Seirin disposable
needles number 5, 0.25630 mm. Once needles were inserted the
participants were instructed to perform diaphragmatic deep
breathing exercises, and were counseled to consume a diet high
in omega 3 fatty acids, magnesium and calcium. Participants were
also encouraged to perform any kind of aerobic exercise, such as
biking, walking, swimming, etc for 30 minutes 3 times per week.
Standardized Educational Booklet and Advice on Exercise
and Relaxation Exercises
Participants randomized to the
control group received an educational booklet, designed by the
British Physiotherapy Association that has been previously
validated to compare with active physiotherapy[7]. The booklet
provided information on causes of back pain, prognosis,
appropriate use of imaging studies and specialists, and exercises
for promoting recovery and preventing recurrences. Participants
receiving the information booklet were instructed to follow the
general advice to remain active, as specified in the booklet. At each
subsequent visit this group of participants received instruction on
specific back stretching and strengthening exercises, and were
educated about relaxation exercises.
Outcomes
Our primary outcome was self-reported disability due to low back
pain, as measured by the Oswestry Low Back Pain Disability
Questionnaire, and Quality of Life, as assessed by the well-
established Short Form 36. The Oswestry questionnaire char-
acterizes the extent to which low back pain impacts on the
participant’s life, work, and daily function and is scored from 0 to
50. The higher the score, the more the low back pain affects his or
her life: 0 to 10 (minimal disability), 11 to 20 (moderate disability):
21 to 30 (severe disability), 31 to 40 (crippled), and 41 to 50 (either
bed-bound or exaggerating their symptoms. The SF-36 is a general
quality of life indicator. The questionnaire aims to assess the
degree to which specific quality of life measurements are affected
by a course of treatment. It is not specific to low back pain, but
rather measures the degree to which various aspects of the
participants’ life were affected by the treatment. Here a higher
score indicates improvement in the particular quality of life
category.
Secondary outcomes assessed included a self reported pain
scale, the Roland Morris Disability questionnaire, forward lumbar
flexion range of motion, weight, body mass index (BMI), use of
non-steroidal anti-inflammatory Drugs (NSAIDS) and use para-
medical interventions. All measures were assessed at baseline,
week 4, 8 and 12. In order to assess the construct validity of the
primary measurement tool for low back pain, we requested
participants to complete the Roland Morris Disability question-
naire. Participants were asked about compliance, adverse events,
and perceived benefit (Naturopathic care group only) at the same
time periods. Compliance to the dietary recommendations was
measured with the use of a diet diary, and through a checklist of
questions about dietary intake at each visit.
Additionally, compliance with treatment was monitored on
a semi-weekly basis using a percentage compliance scale, with
,70% adherence considered non-compliant at each time point.
Statistical analysis
All analyses were performed by a statistician (QZ) under blinded
conditions using SAS/STAT (Version 8, Cary, NC). A sample of
about 36 in each group was found to be adequate to detect a 10%
change in the Oswestry Low Back Pain Disability Questionnaire
assuming a between patient variability of 15% [8,9], a two-sided
significance level of 5%, and a power of 80%. A 5-point difference
(10%) between groups has been established as the minimal
clinically important difference.[9,10]
Data were analyzed according to intention-to-treat. The means
over the 12 week period were plotted for the outcomes of
Oswestry, SF-36 physical component and SF-36 mental compo-
nent separately. To assess the treatment effect for each group we
calculated the mean change scores between groups at week 12 and
the baseline. For any missing data at week 12, we carried forward
the value at week 8. The statistical significance of the changes for
each group was tested by the paired t-test and the exact 2-sided p-
value is reported. To compare the change scores between groups,
the two-sample t-test was performed.
The construct validity of the Oswestry questionnaires was
evaluated in comparison to the Roland and Morris questionnaire.
Our a priori assumption was good correlation between the 2
established questionnaires (.0.5). We used the Pearson Correla-
tion Coefficient at baseline and at week 12 separately by active
group and the control group.
RESULTS
Recruitment and Follow-up of Patients
We screened 84 participants eligible for the study. We excluded 9
participants for the following reasons: unable to commit to the
study time commitments (n = 3); no lower back pain at time of
assessment (n = 2); pregnant (n = 2); previous spinal surgery (n = 1);
and, too late in accepting enrolment (n = 1). A total of 75
participants were enrolled into the study and randomized (39 to
naturopathic care and 36 to the control intervention) and 63
completed the full study (Figure 1.). Of the 6 participants that
dropped out, 5 were female, all were in the control group and all
dropped out prior to assessing week 2 outcomes. The reasons cited
for dropping out were: dissatisfaction with treatment (n = 3) and
unable to commit to the time required (n = 3).
Back Pain Naturopathic Care
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Baseline characteristics
Table 1 displays the baseline characteristics of the groups. The
majority of participants were internal workers with an appropriate
make up of mixed ethnicities. The mean scores on the SF-36
general health perceptions subscale were below national
norms[11]. All participants had had back pain for greater than
six weeks that they reported as minimally disabling according to
the scoring system of the Oswestry Low Back Pain Disability
Questionnaire.
Study treatments
Data was available on 100% (39) of the naturopathic care group at
week 8 and 75% (27) of the control group at week 8. Complete
data on participants at week 12 was available on 92% and 63%
respectfully.
Compliance was perfect for acupuncture and relaxation
breathing techniques for participants randomized to naturopathic
care. Compliance to dietary recommendations was excellent (87%
of all visits, standard deviation [SD] 16%). Participants in the
control group reported excellent compliance to the stretching and
exercise interventions (81% of all visits, SD 28%). No important
adverse effects were reported in either group.
Outcomes
Primary Outcomes The difference in mean change scores in
the Oswestry Low Back Pain Disability Questionnaire from
baseline to week 12 resulted in a significant reduction of
disability in the naturopathic care group compared to the
control group (median change = 25; p = ,0.0001; Table 2).
Figure 2 displays the mean scores for the Oswestry Low
Back Pain Disability Questionnaire per group over the 12-week
study period. SF-36 scores also displayed a significant difference
between treatment groups for both the aggregate physical
component (median change = 9.25; p = ,0.0001) and the
aggregate mental component (median change = 4.26; p = 0.0045)
and for all domains except vitality (Table 3). Figures 3 and 4
display the mean SF-36 scores for the mental and physical
aggregate components, respectively, over the 12-week study
period.
Secondary Outcomes Subjects receiving naturopathic care
also demonstrated greater improvement in spinal flexion (mean
change score = 5.49cm; 95% CI = 2.13 to 8.85), weight loss (mean
change score = 21.46; 95% CI = 22.60 to 20.32), and BMI
(mean change score = 20.52; 95% CI = 20.96 to 20.08) as
compared to the control group (Table 2).
Figure 1. Flow diagram of participants through trial
doi:10.1371/journal.pone.0000919.g001
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The use of NSAIDs for the treatment of pain was minor across
groups. Participants in the Naturopathic care group reported
a mean baseline use of NSAIDS as 7.23 pills per week (range 0–49)
per week, while the baseline use of NSAIDs in the control group
was 1.2 pills per week (range 0–15). NSAID use in the
naturopathic group reduced to 0.5 after 12 weeks of treatment.
The control group reported a mean change of NSAID use from
1.2 per week at baseline to 2.5 after 12 weeks of treatment.
Optional Cross-over period
After completing the study, thirteen self-selected participants
previously assigned to the control group crossed over to the
naturopathic care intervention for a period of 4 weeks. After
4 weeks of naturopathic care, the mean Oswestry Low Back Pain
Disability Questionnaire score of the crossover group was
significantly reduced from week 12 (p = 0.0053) and was not
different from the week 12 scores of the original naturopathic care
group (p = 0.23). Aggregate mental and physical component scores
of the SF-36 changed significantly within the crossover group after
4 weeks of care (p = 0.026 and p = 0.044) and were no longer
different from the original naturopathic care group at week 12
(p = 0.53 and p = 0.24).
Construct validity
Construct validity of the Oswestry questionnaire provided
excellent correlation to the Roland and Morris questionnaire at
baseline (0.72) and at week 12 in the Naturopathic care group
(0.79) and control group (0.70).
DISCUSSION
For Canada Post employees with chronic non-specific low back
pain, we found that naturopathic care was superior to a standard-
ized educational booklet and advice on exercise and relaxation
techniques in reducing reported disability, weight, and BMI, and
in increasing the general quality of life and lumbar flexion of
participants. To our knowledge, this is the first study to examine
naturopathic care for chronic low back pain.
Interpretation
Ours is not the first study to examine the role of acupuncture in
treating low back pain[12]. It is however, the first study to
combine acupuncture with relaxation techniques and dietary
recommendations; a combination of treatment options reflecting
naturopathic care. There are several strengths to consider when
interpreting this trial. We used clearly defined entry requirements,
randomized participants, and analyzed our data using intention-
to-treat. As blinding of participants and providers was impossible
Table 1. Characteristics of participant groups.
......................................................................
Naturopathic care Control
Mean age (SD) 45.31 (7.46) 48.02 (8.27)
Percent women 56% 44%
Weight kgs (SD) 79.12 (14.39) 78.66 (18.13)
BMI 28.70 (4.87) 27.69 (3.68)
Number in shift 19 day 15 day
8 letter carrier 4 letter carrier
5 afternoon 7 afternoon
5 night 9 night
2 truck driver 1 truck driver
Percent day shift 48.7% 41.7%
White 22 17
Black 3 4
South Asian 11 12
East Asian 2 3
Aboriginal 1 0
Oswestry score 11.85 ( 8.18) 11.08 (7.83)
SF-36 Mental aggregate 21.10 (0.86) 21.19 (0.91)
SF-36 Physical aggregate20.27 (1.15) 20.06 (1.18)
NSAID use, Median
[range]
3 [0–49] (n = 21) 0[0–15] (n = 19)
doi:10.1371/journal.pone.0000919.t001
..........................................................................................
Table 2. Comparisons for Oswestry, Roland and Morris, Pain Scale, Spinal Flexion, Weight and BMI
..................................................................................................................................................
Outcomes Group
Baseline Median
(Q1–Q3)* (N)
Week 12** Median
(Q1–Q3) (N)
Change at 12 wks
from baseline Median
(Q1–Q3) (N, P-value)
Difference of changes
between groups Mean
(95%CI) P-value
Oswestry
1
Naturopathic 10 (5,16) (39) 4 (1,9) (39) 25(27,22) (39, 0.0007) ,0.0001
Control 9 (4,16) (30) 12 (4,16) (27) 0 (22,4) (27, 0.7126)
Roland and Morris Naturopathic 7 (3,13) (39) 2 (0,6) (39) 24(27,22) (39, ,0.0001) ,0.0001
Control 5 (2,7) (30) 8 (4,10) (27) 2 (1,25) (27, 0.0613)
Pain Scale (10-point) Naturopathic 2 (1,3) (39) 1 (0,1.5) (39) 21(21.5,0) (39, ,0.0001) ,0.0001
Control 2 (1,2) (30) 2 (1,2) (27) 0 (0,1) (27, 0.2585)
Spinal Flexion (cm) Naturopathic 30 (24,34) (39) 34 (30.5,38) (39) 4.5 (2.5,7) (39, 0.0006) ,0.0001
Control 31 (28,34.5) (30) 30.5 (27.5,33) (27) 20.5 (21.5,0) (27, 0.3171)
Weight (kg) Naturopathic 79.12614.39 (38) 77.61614.02 (38) 21.51 (22.44, 20.58) (38, 0.0022) 2
1.46 (22.60, 20.32) 0.0052
Control 78.66618.13 (30) 78.83618.21 (27) 20.05 (20.46, 0.36) (27, 0.8111)
BMI Naturopathic 28.7064.87 (38) 28.1264.47 (38) 20.58 (20.94, 20.22) (38, 0.0023) 20.52 (20.96, 20.08) 0.0106
Control 27.6963.68 (30) 27.7463.68 (27) 20.06 (20.23, 0.12) (27, 0.5063)
*
The data is reported as Mean6Std if the sample is normally distributed. Q1 and Q3 are the 1
st
quartile and the 3
rd
quartile of the sample
**
the week 8 value was used for week 12 If missing value was occurred at week 12.
1
Primary outcome measure
doi:10.1371/journal.pone.0000919.t002
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Figure 2. Oswestry questionnaire measuring disability over 12 weeks
doi:10.1371/journal.pone.0000919.g002
Table 3. Comparisons for SF-36 outcomes
..................................................................................................................................................
Outcomes SF-36 Group
Baseline
Mean6Std (N)
Week 12*
Mean6Std (N)
Change at 12 wks from baseline
Mean (95%CI) (N, P-value)
Difference of changes
between groups Mean
(95%CI) P-value
Aggregate physical
component
1
Naturopathic care 38.9668.56 (39) 48.2168.10 (39) 9.25 (6.81, 11.68) (39, ,0.0001) 8.47 (5.05, 11.87) ,0.0001
Control 39.7568.39 (30) 40.5768.58 (27) 0.78 (21.45, 3.02) (27, 0.4780)
Aggregate mental
component
1
Naturopathic care 47.30611.46 (39) 51.5768.05 (39) 4.26 (0.88, 7.65) (39, 0.0149) 7.00 (2.25, 11.75) 0.0045
Control 49.15611.18 (30) 47.57610.03 (27) 22.74 (25.86, 0.39) (27, 0.0835)
Physical
functioning
Naturopathic care 40.9569.97 (39) 48.0869.32 (39) 7.12 (4.69, 9.56) (39, ,0.0001) 5.56 (1.93, 9.20) 0.0033
Control 40.13611.51 (30) 41.68611.01 (27) 1.56 (21.17, 4.29) (27, 0.2508)
Role physical Naturopathic care 40.97610.88 (39) 49.6369.25 (39) 8.67 (5.17, 12.16) (39, ,0.0001) 11.48 (6.47, 16.49) ,0.0001
Control 42.5769.94 (30) 40.9869.66 (27) 22.81 (26.28, 0.66) (27, 1077)
Bodily pain Naturopathic care 36.8067.71 (39) 47.9267.88 (39) 11.12 (7.99, 14.25) (38, ,0.0001) 10.83 (6.26, 15.40) ,0.0001
Control 38.7667.51 (30) 39.2166.48 (27) 0.29 (23.00, 3.58) (27, 0.8578)
General health Naturopathic care 44.4368.80 (39) 50.4867.61 (39) 6.05 (3.31, 8.78) (38, ,0.0001) 7.18 (3.58, 10.77) 0.0002
Control 44.9469.68 (30) 43.9069.43 (27) 21.13 (23.02, 0.76) (27, 0.2310)
Vitality Naturopathic care 44.2569.36 (39) 50.0969.68 (39) 5.84 (2.58, 9.11) (38, 0.0009) 3.87 (20.50, 8.25) 0.0814
Control 46.1669.92 (30) 48.7468.87 (27) 1.97 (20.53, 4.46) (27, 0.1177)
Social functioning Naturopathic care 41.75611.36 (39) 50.7069.04 (39) 8.95 (5.45, 12.45) (38, ,0.0001) 10.57 (5.67, 15.47)
,0.0001
Control 46.1269.97 (30) 44.93611.12 (27) 21.62 (24.83, 1.60) (27, 0.3106)
Role emotional Naturopathic care 45.61612.75 (39) 50.5068.11 (39) 4.88 (0.70, 9.07) (38, 0.0234) 8.05 (2.08, 14.02) 0.0090
Control 44.74612.32 (30) 42.92612.53 (27) 23.17 (27.26, 0.92) (27, 0.1236)
Mental health Naturopathic care 46.33611.23 (39) 50.9568.60 (39) 4.62 (1.84, 7.40) (38, 0.0018) 7.44 (3.58, 11.29) 0.0003
Control 47.99610.30 (30) 46.1569.18 (27) 22.82 (25.27, 20.36 (27, 0.0260)
Week 12*-the value at week 8 was used for week 12 If the missing value was occurred.
1
Primary outcome measure
doi:10.1371/journal.pone.0000919.t003
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due to the nature of the interventions, we blinded the analysts to
group allocation. We contacted the participants who dropped out
in order to determine their health status and reasons for dropping
out. In addition, we gave the control group participants the option
to cross-over at 12 weeks to receive naturopathic care. For the 13
participants (56%) who chose this option, their Oswestry Low
Back Pain Disability Questionnaire scores and SF-36 scores
improved significantly over a period of 4 weeks.
There are also several limitations to consider in this study. The
naturopathic care group had a more active intervention than the
control group; however, both groups were provided with advice on
exercise and relaxation techniques and recent trials have found the
educational booklet we used to be equivalent to routine active
physiotherapy for the management of chronic low back pain
[7,13]. Despite the evidence supporting the effectiveness of this
particular educational booklet, generally one could not assume the
control intervention to be of equal benefit as that of an active
intervention [14]. It may be, and is likely, that participants in the
control group were aware that their intervention was a control
intervention and so found their treatment less desirable. This likely
explains why drop-outs were all from the control group. Our
sample size was relatively small to detect small effects. However,
we were appropriately powered to detect the large effects observed
in the trial, as confidence intervals around the primary outcomes
Figure 3. Mean SF-36 mental components aggregate over 12 weeks
doi:10.1371/journal.pone.0000919.g003
Figure 4. Mean SF-36 physical components over 12 weeks
doi:10.1371/journal.pone.0000919.g004
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were precise. The lack of blinding of interventions is problematic,
and indeed is a challenge in educational and physical manipula-
tion trials. It is possible that certain sub-groups in the trial would
benefit more or less from a particular treatment. We did not
conduct sub-group analyses on our population as we believe our
trial, and most trials, are underpowered to provide appropriate
sub-group analyses [15,16]. Further, whereas compliance to
acupuncture and deep-breathing was directly observed by
clinicians we relied on patient reported compliance to exercises
and diet. It is possible that patient recall was insufficient. However,
we did not expect nutrition to be the largest therapeutic effect and
compliance to acupuncture and deep-breathing was directly
observed by clinicians. Finally, in pragmatic randomized control
trials such as this one, it is difficult to ascertain the non-specific or
context effects of the treatments that were given.
Generalizability
The generalizability of our study is limited as we enrolled
participants from one large corporation and union. We believe
however, that these conditions reflect a large number of corporate
settings and clinicians and providers dealing with occupational
health settings should find this study of interest. We additionally
acknowledge that naturopathic care does vary according to
practitioners and often includes different therapies than used in
our study. Our naturopathic care intervention was designed in
consensus with a team of academic naturopathic physicians to
reflect current practices in Ontario.
Overall Evidence
An important finding from this trial was the effectiveness of the
Naturopathic care. We expected to see an effect on quality of life
as the Naturopathic care group received treatment aimed at
relaxation and improved nutrition. Quality of life appears to be
linked to chronic back pain[1] and so our finding on quality of life
improvement suggests that further research on the long-term
effects of Naturopathic care would be of interest to patients.
Further to this, we observed a significant decrease in the weight
and BMI of participants in the Naturopathic care group compared
to the control group, with a relative decrease of 1.46 Kgs (95% CI,
22.60, 20.32) between groups (P = 0.0052) and a mean decrease
of 0.52 ( 20.96, 20.08) BMI between groups (P for differ-
ence = 0.01).
Many patients access complementary therapy providers over
physicians or more traditionally regulated professions due to the
perception that CAM practitioners provide a more holistic
treatment package, which examines physical complaints along
with mental and emotional concerns, and indeed sometimes
spiritual concerns[17]. Our study did not aim to determine
participant contentment with Naturopathic care over other
therapies, but we did receive systematic feedback in the form of
optional comments on the forms that the participants in the
Naturopathic care group increased their interest in seeking CAM
care and developed an increased appreciation for Naturopathic
care.
The results from this first randomized trial evaluating
naturopathic care for chronic low back pain suggest that further
research is warranted to determine the generalizability of this
intervention, the specific contribution of individual treatment
components, and the cost benefit associated with this therapy.
SUPPORTING INFORMATION
Protocol S1 Trial protocol
Found at: doi:10.1371/journal.pone.0000919.s001 (0.05 MB
DOC)
Checklist S1 CONSORT checklist
Found at: doi:10.1371/journal.pone.0000919.s002 (0.06 MB
DOC)
ACKNOWLEDGMENTS
The authors wish to thank the corporate members and the Union members
of the planning committee.
Author Contributions
Conceived and designed the experiments: EM JB OS KC DS BB GG.
Performed the experiments: OS KC. Analyzed the data: EM JB OS KC
DS GG QZ. Contributed reagents/materials/analysis tools: EM OS KC
GG QZ. Wrote the paper: EM JB OS KC DS BB GG. Other: Enrolled
patients: EM.
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23–30.
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and productivity cost burden of the ‘‘top 10’’ physical and mental health
conditions affecting six large U.S. employers in 1999. J Occup Environ Med 45:
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4. Cherkin DC, Deyo RA, Sherman KJ, Hart LG, Street JH, et al. (2002)
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Back Pain Naturopathic Care
PLoS ONE | www.plosone.org 7 September 2007 | Issue 9 | e919
    • "Despite this bold statement, relatively little is known about the observed practices of regulated naturopathic doctors. Some research attests to effectiveness of the naturopathic approach, as measured by pragmatic, whole-practice randomized controlled trials45678, as well as observational studies91011 and patient experiences [12] , while a much larger, and emerging evidence base exists for individual therapies for various conditions, some supportive of use, some demonstrating a lack of clear efficacy. It has also been posited that a substantial amount of value in naturopathic care is related to the quality time spent in patient care to achieve understanding and compliance, as well as the patientcentered collaborative model that naturopathic doctors bring to the patient-practitioner encounter [13]. "
    [Show abstract] [Hide abstract] ABSTRACT: Historically, alongside regulatory and jurisdictional differences in scope of practices, practice patterns of naturopathic doctors (NDs) have varied widely to promote holistic or whole-person treatment using a variety of therapies including: controlled substances, minor surgery, a variety of complementary therapies, as well as both novel and conventional assessments. However, little is known about the observed practice patterns of NDs, the services provided to their patients, or the type of conditions for which patients of NDs are seeking treatment. In order to address this gap, a cross-sectional descriptive analysis of the largest Canadian teaching clinic for NDs was undertaken to better understand the services provided to the community and increase the knowledge regarding the use of naturopathic medicine. Data stemmed from two sources at the Toronto, Ontario clinic: a passive patient satisfaction survey, and the clinic's point-of-sale (POS) system. Data included patient demographics, postal codes, health services utilization, ICD-10 codes, therapies employed, along with other data relating to the financial transactions associated with the visit. Simple descriptive statistics and the Kruskal-Wallis test were used to compare different age-based groups and examine health services use between years. This study was approved by the Research Ethics Board of the Canadian College of Naturopathic Medicine. 13,412 patients were treated in 76,386 patient visits spanning three clinic years. Median age of patients was 37; females outnumbered males (2.6:1) in all age-based groups except the pediatric population. In the patient satisfaction survey, there were 1552 potential survey respondents; with 118 responses received (response rate: 7.6%). Obtaining health education, health prevention and help with chronic health conditions were the primary motivators for patient visits identified in the patient survey. The clinic attracts people from a wide area in the metropolitan Toronto and surrounding region with health concerns and diagnoses that are consistent with primary care, providing health education and addressing acute and chronic health conditions. Further explorations into health services delivery from the broader naturopathic or other complementary/alternative medical professions would provide greater context to these findings and expand understanding of the patients and type of care being provided by these health professionals.
    Full-text · Article · Dec 2015
    • "Similarly, for evaluations of non-pharmacological therapies, appropriate comparators were chosen based on customary usual care practices, such as standardized physical exercises for rotator cuff tendonitis and standardized psychotherapy for anxiety [26,27,32]. The studies analyzed here are all examples of evaluations of actual practice outcomes, i.e., pragmatic research, which most accurately estimates the effectiveness in a real world setting, and thus the results have greater external validity than could be achieved from any placebocontrolled clinical trial434445. "
    [Show abstract] [Hide abstract] ABSTRACT: Background: Naturopathic medicine (NM) is a holistic approach to primary care that almost always employs multi-modal interventions, i.e. nutrition and lifestyle change recommendations plus dietary supplements. While evidence supports individual elements of NM, the whole practice is often critiqued for its lack of evidence. Methods: We systematically searched PubMed/MEDLINE, EMBASE, CINAHL, Cochrane Library and AMED from inception to April, 2012 as well as conducting hand searches of existing grey literature. For inclusion, studies had to report results from multi-modal treatment delivered by North American naturopathic doctors. The effect size for each study was calculated; no pooled analysis was undertaken. Risk of bias was assessed using the Cochrane risk of bias as well as Downs and Black tools. Results: Fifteen studies met inclusion criteria, investigating a range of chronic diseases of public health significance. Studies were of good quality and had low to medium risk of bias including acknowledged limitations of pragmatic trials. Effect sizes (Cohen's d ) for the primary medical outcomes varied and were statistically significant (p<0.05) in 10 out of 13 studies. A quality of life metric was included in all of the randomized controlled trials with medium effect size and statistical significance in some subscales. Conclusions: Previous reports about the lack of evidence or benefit of NM are inaccurate; a small but compelling body of research exists. Further investigation is warranted into the effectiveness of whole practice NM for across a range of health conditions. [PROSPERO 2012:CRD42012002176]
    Full-text · Article · Apr 2015 · BMC Complementary and Alternative Medicine
    • "Similarly, for evaluations of non-pharmacological therapies, appropriate comparators were chosen based on customary usual care practices, such as standardized physical exercises for rotator cuff tendonitis and standardized psychotherapy for anxiety [26,27,32]. The studies analyzed here are all examples of evaluations of actual practice outcomes, i.e., pragmatic research, which most accurately estimates the effectiveness in a real world setting, and thus the results have greater external validity than could be achieved from any placebocontrolled clinical trial434445. "
    [Show abstract] [Hide abstract] ABSTRACT: Background: Naturopathic medicine (NM) is a holistic approach to primary care that almost always employs multi-modal interventions, i.e. nutrition and lifestyle change recommendations plus dietary supplements. While evidence supports individual elements of NM, the whole practice is often critiqued for its lack of evidence. Methods: We systematically searched PubMed/MEDLINE, EMBASE, CINAHL, Cochrane Library and AMED from inception to April, 2012 as well as conducted hand searches of existing grey literature. For inclusion, studies had to report results from multi-modal treatment delivered by North American naturopathic doctors. The effect size for each study was calculated; no pooled analysis was undertaken. Risk of bias was assessed using the Cochrane risk of bias as well as Downs and Black tools. Results: Fifteen studies met inclusion criteria, investigating a range of chronic diseases of public health significance. Studies were of good quality and had low to medium risk of bias including acknowledged limitations of pragmatic trials. Effect sizes (Cohen's d) for the primary medical outcomes varied and were statistically significant (p<0.05) in 10 out of 13 studies. A quality of life metric was included in all of the randomized controlled trials with medium effect size and statistical significance in some subscales. Conclusions: Previous reports about the lack of evidence or benefit of NM are inaccurate; a small but compelling body of research exists. Further investigation is warranted into the effectiveness of whole practice NM across a range of health conditions. [PROSPERO 2012:CRD42012002176]
    Article · Jan 2015 · BMC Complementary and Alternative Medicine
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