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Background Low back pain is among the most common and costly chronic health care conditions. Recent research has highlighted the common occurrence of non-specific low back pain in adolescents, with prevalence estimates similar to adults. While multiple clinical trials have examined the effectiveness of commonly used therapies for the management of low back pain in adults, few trials have addressed the condition in adolescents. The purpose of this paper is to describe the methodology of a randomized clinical trial examining the effectiveness of exercise with and without spinal manipulative therapy for chronic or recurrent low back pain in adolescents. Methods/design This study is a randomized controlled trial comparing twelve weeks of exercise therapy combined with spinal manipulation to exercise therapy alone. Beginning in March 2010, a total of 184 participants, ages 12 to 18, with chronic or recurrent low back pain are enrolled across two sites. The primary outcome is self-reported low back pain intensity. Other outcomes include disability, quality of life, improvement, satisfaction, activity level, low back strength, endurance, and motion. Qualitative interviews are conducted to evaluate participants’ perceptions of treatment. Discussion This is the first randomized clinical trial assessing the effectiveness of combining spinal manipulative therapy with exercise for adolescents with low back pain. The results of this study will provide important evidence on the role of these conservative treatments for the management of low back pain in adolescents. Trial registration (ClinicalTrials.gov NCT01096628).
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S T U D Y P R O T O C O L Open Access
Spinal manipulation and exercise for low back pain
in adolescents: study protocol for a randomized
controlled trial
Craig Schulz
1*
, Brent Leininger
1
, Roni Evans
1
, Darcy Vavrek
2
, Dave Peterson
3
, Mitchell Haas
2
and Gert Bronfort
1
Abstract
Background: Low back pain is among the most common and costly chronic health care conditions. Recent
research has highlighted the common occurrence of non-specific low back pain in adolescents, with prevalence
estimates similar to adults. While multiple clinical trials have examined the effectiveness of commonly used
therapies for the management of low back pain in adults, few trials have addressed the condition in adolescents.
The purpose of this paper is to describe the methodology of a randomized clinical trial examining the effectiveness
of exercise with and without spinal manipulative therapy for chronic or recurrent low back pain in adolescents.
Methods/design: This study is a randomized controlled trial comparing twelve weeks of exercise therapy
combined with spinal manipulation to exercise therapy alone. Beginning in March 2010, a total of 184 participants,
ages 12 to 18, with chronic or recurrent low back pain are enrolled across two sites. The primary outcome is
self-reported low back pain intensity. Other outcomes include disability, quality of life, improvement, satisfaction,
activity level, low back strength, endurance, and motion. Qualitative interviews are conducted to evaluate
participantsperceptions of treatment.
Discussion: This is the first randomized clinical trial assessing the effectiveness of combining spinal manipulative
therapy with exercise for adolescents with low back pain. The results of this study will provide important evidence
on the role of these conservative treatments for the management of low back pain in adolescents.
Trial registration: (ClinicalTrials.gov NCT01096628).
Keywords: Back pain, Pain, Spinal manipulation, Musculoskeletal manipulations, Exercise, Randomized controlled trial,
Adolescent
Background
Low back pain prevalence and burden in adolescents
Low back pain (LBP) in adolescents has become increas-
ingly recognized as a public health concern, with an esti-
mated one year prevalence of 34% [1]. Often beginning at
a young age, the prevalence of LBP quickly mirrors that of
adults by the late teenage years [2]. The natural history of
LBP in adolescents is also similar to adults with recurrent
symptoms occurring in over one half of patients [3]. Im-
portantly, recurrent LBP in adolescence is highly associ-
ated with continued pain in adulthood [4,5].
While the prevalence of LBP steadily increases with age
during childhood, the number of adolescents seeking care
does not dramatically increase until mid-adolescence [6].
Care-seeking for LBP in childhood is strongly influenced
by pain intensity and limitations in daily activities [7]. Ap-
proximately one-quarter of adolescents with LBP miss
school because of their LBP condition [8].
Although little is currently known regarding the soci-
etal cost of LBP in adolescents, the disease burden in
adulthood is substantial. The 2010 Global Burden of
Disease study ranked LBP as the leading cause of years
lived with disability in the world [9]. After respiratory
disorders, LBP causes more short-term work absence
that any other condition [10]. In the US alone, costs as-
sociated with LBP are estimated between $20 and $120
* Correspondence: cschulz@nwhealth.edu
1
Wolfe-Harris Center for Clinical Studies, Northwestern Health Sciences
University, 2501 W 84th St, Bloomington, MN 55431, USA
Full list of author information is available at the end of the article
CHIROPRACTIC & MANUAL THERAPIES
© 2014 Schulz et al.; licensee BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative
Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and
reproduction in any medium, provided the original work is properly credited. The Creative Commons Public Domain
Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article,
unless otherwise stated.
Schulz et al. Chiropractic & Manual Therapies 2014, 22:21
http://www.chiromt.com/content/22/1/21
billion annually and are increasing [11,12]. In addition,
there are growing concerns regarding the overutiliza-
tion and safety of frequently prescribed medical treat-
ments, particularly in light of the lack of evidence to
support their effectiveness [13].
Recognizing that LBP begins at an early age and be-
comes burdensome and costly in adulthood, research
focusing on conservative management strategies for ad-
olescents with LBP is urgently needed.
Treatment of adolescent LBP
Whereas multiple randomized trials have examined the ef-
fectiveness of commonly used conservative treatments for
LBP in adults [14-17], few have been performed in adoles-
cent LBP populations. Three small randomized clinical tri-
als have evaluated exercise as a treatment approach for
adolescent LBP [18-20]. Collectively, the published trials
to date suggest exercise may be effective in reducing pain
and disability in adolescents with LBP, but larger, high
quality trials are needed. Interestingly, although spinal ma-
nipulative therapy (SMT) is commonly used for children
with spine conditions [21], no randomized trials examin-
ing the effectiveness of SMT for adolescent LBP have been
published to date [22].
Study aims
Our primary aim is to determine the relative clinical
effectiveness of 1) exercise with SMT versus 2) exercise
alone in 184 adolescents with sub-acute recurrent (2-12
weeks) or chronic (>12 weeks) LBP, measured at 12, 26,
and 52 weeks. The primary outcome measure is patient-
rated LBP at these time points. Our hypothesis is that the
addition of SMT to exercise will reduce pain more than
exercise alone.
Our secondary aims are to assess between-group dif-
ferences in disability, quality of life, improvement, sa-
tisfaction, activity level, dynamic lumbar motion, and
trunk muscle endurance. In addition, we will assess the
participants perceptions of treatment using qualitative
interviews.
Methods/design
Design & setting
This trial began in March 2010, and is a two-site,
parallel-group randomized controlled trial. Participants
are being recruited at Northwestern Health Sciences
University in Bloomington, MN and the University of
Western States in Portland, OR. All treatments are pro-
vided within university-associated outpatient clinics.
Ethical approval
Ethical approval has been granted by the Institutional
Review Boards of the participating institutions (Project
ID: 1-77-10-09).
Recruitment
Potential subjects are recruited from the Minneapolis/St.
Paul, MN and Portland, OR metropolitan areas using
multiple methods. The primary recruitment method is tar-
geted mailings to households with adolescents. Other re-
cruitment methods include internet advertising through
Facebook and Craigslist, newspaper advertising, flyers, and
targeted referral letters to local physicians specializing in
pediatrics or musculoskeletal conditions and coaches of
sport programs at local schools.
Participants
Adolescents, age 12 to18, with a history of sub-acute re-
current or chronic low back pain are eligible to partici-
pate. The inclusion/exclusion criteria are described in
Table 1 .
Baseline assessments
Interested individuals are assessed for eligibility and com-
pliance during a scripted telephone interview followed by
three distinct baseline evaluations. For participants ages
12-17, written assent is obtained in addition to written
informed consent from a legal guardian. Participants 18
years of age provide written informed consent. Indi-
viduals complete a clinical health history and physical
exam. Plain film radiographs are taken if suspicion of a
specific cause of LBP is present. To maintain consistency
across sites, study clinicians and investigators, who are
blinded to upcoming treatment assignment, meet (in-
person and by teleconference) to review each case to
determine eligibility. Self-report outcome measures and
blinded objective assessments of lumbar spine motion,
strength, and endurance are completed at the first two
baseline evaluations. An accelerometer is issued to po-
tential participants to monitor their physical activity
level for the week prior to treatment assignment. Partici-
pants are assigned to study treatments at the third base-
line evaluation. The participants flow through baseline
evaluations and treatment is shown in Figure 1.
Treatment allocation & concealment
As participants become eligible, study staff masked to
upcoming treatment assignments use a dynamic alloca-
tion (rank-order minimization) computer program to as-
sign subjects to treatment [23-25]. Gender, age, pain
duration, and intensity are entered into the program to
balance patient characteristics between groups.
A computer-generated random allocation sequence se-
cured in sealed, opaque, sequentially numbered enve-
lopes is used to randomize the first six participants at
each site to provide a seedgroup of participants for
the dynamic allocation program. Envelopes are also used
as a back-up in the event the treatment allocation pro-
gram becomes unavailable.
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Interventions
All interventions are provided by study staff at
Northwestern Health Sciences University and the Univer-
sity of Western States research clinics. The physical nature
of the treatments prevents blinding of participants and
providers to treatment assignment. Participants are asked
not to receive care for their LBP condition from other pro-
viders during the active treatment phase (12 weeks). Data
regarding non-study care is collected in the self-report
questionnaires.
Treatment providers have been trained in protocols
to ensure standardized intervention and documenta-
tion. To facilitate protocol adherence, clinical records
are monitored weekly by research staff. Non-adherent
providers and patients are contacted using various
methods(e.g.,in-person,byphone,oremail)toresolve
compliance issues.
Exercise therapy (ET)
There are three components to the ET program: self-
care education, supervised exercise visits, and home ex-
ercise. The overall objectives are to help adolescents
manage their LBP and prevent future LBP recurrences.
The total number of visits ranges from 8 to 16, depend-
ing on the patients needs (e.g., ability to perform exer-
cises independently). Experienced chiropractors and
exercise therapists have been trained and certified to de-
liver the program.
Table 1 Inclusion and exclusion criteria
Inclusion criteria Exclusion criteria
12 to 18 years old Spinal manipulative therapy or exercise therapy in the previous
month
Either:
Sub-acute recurrent non-specific low back pain defined as current
episode of 2 to 12 weeks duration AND an additional 2 week episode
of back pain in the past year
Ongoing treatment for low back pain by other health care providers
Other serious physical or mental health conditions
(e.g., uncontrolled diabetes, cancer)
OR Contraindications to study treatments including acute disc
herniation, clinical
Chronic non-specific low back pain defined as a current episode 12
weeks duration instability of the lumbar spine, or inflammatory arthritides
Low back pain intensity 3 on 0 to 10 numerical rating scale Benign joint hypermobility syndrome
Stable prescription medication plan (no changes to prescription medications
that affect musculoskeletal pain in the previous month)
Baseline Evaluation 1
Week 4 & 8
Week 12 Evaluation
Exercise & Spinal
Manipulative Therapy
(8-16 visits over 12 weeks)
n=92
Exercise
(8-16 visits over 12 weeks)
n=92
Week 26 Evaluation
Week 52 Evaluation
Self-report Outcomes
Objective Biomechanical Outcomes
Self-report Outcomes
Self-report Outcomes
Objective Biomechanical Outcomes
Treatment Assignment
Baseline Evaluation 2
Baseline Evaluation 3
Self-report Outcomes
Objective Biomechanical Outcomes
Qualitative Interview
Informed Consent/Assent
Self-report Outcomes
Screening Exam
Objective Biomechanical Outcomes
Self-report Outcomes
Phone Interview
Figure 1 Study flow diagram. Self-report Outcomes: Primary and secondary outcomes (e.g., Pain, Disability). Objective Biomechanical
Outcomes: Torso muscle strength & endurance; Continuous lumbar motion; Accelerometer readings for 7 consecutive days. Qualitative
Interview: Face-to-face interviews assessing treatment experience and expectations.
Schulz et al. Chiropractic & Manual Therapies 2014, 22:21 Page 3 of 9
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The details of the exercise program are outlined in
Table 2. Each visit starts with 10 minutes of self-care
education to help patients establish and monitor goals
aligned with the exercise program and enhance their
understanding of LBP. Participants are taught the im-
portance of movement and activity, pain management
techniques, and methods for developing spinal posture
awareness during activities of daily living (e.g., lifting,
pushing, pulling, sitting, getting out of bed, and using a
backpack). Individuals are provided printed instructions
and photos of exercises in addition to a modified Back
in Action [26] binder, which emphasizes movement and
restoration of normal function and fitness [27,28]. The
supervised exercises begin with a 5-minute, light aerobic
warm up, followed by stretching and strengthening ex-
ercises (bridge, abdominal crunches, quadruped, side
bridge, and back extensions). Participants begin with ex-
ercises appropriate for their fitness level and gradually
Table 2 Treatment interventions
Intervention Spinal Manipulative Therapy (SMT) Exercise Therapy (ET)
Type High velocity, low amplitude SMT preferred ET Visit
Self-care education
Other manual therapies if needed Supervised exercise
Low velocity, low amplitude SMT or mobilization Aerobic warm up
Flexion-distraction manipulation
Drop-table assisted SMT Stretching (cat/camel, piriformis, hamstring, laying back rotation)
Up to 5 minutes adjunct therapies to facilitate SMT:
Light soft tissue massage, active and passive stretching,
ischemic compression of tender points, ice and heat
Strengthening (bridge, abdominal curl, back extension, side
bridge, quadruped, and squats) with changes in body positioning
and addition of labile surface (i.e., gym ball) for progressions
Home Exercise
Instructions provided at treatment visits and supplemented by
take home materials
Design &
delivery
format
Individualized: number of visits, spinal levels treated, SMT and
manual therapy technique used and adjunct therapies
determined by provider according to patient needs and
tolerance
ET Visit
Supervised
Individualized: number of visits, exercise progressions determined
by provider
Home Exercise
Unsupervised
Delivery
method
One-on-one treatment visit ET Visit
Treatment provided by licensed chiropractor One-on-one exercise therapy visit
Instructions and supervision provided by licensed chiropractor or
exercise therapist
Home Exercise
Instructions provided at treatment visits
Instructions supplemented by take home materials (exercise
photos, modified Back in Action [26] book)
Dose 8 to 16 treatment visits ET Visit
10 to 20 minutes per visit 8 to 16 visits
Maximum frequency: 2 times/week 45 minutes per visit
10 minutes self-care education
5 minutes aerobic exercise warm up
30 minutes supervised exercise
Stretching: 1 set; 3 reps
cat/camel; 1 rep each side for other stretches
Strengthening: 2 sets; 16 to 20 repetitions each exercise
Home Exercise
Maximum frequency: 2 times/week
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progress in difficulty by changing body position and/or
using a labile surface (i.e., gym ball). Participants are en-
couraged to perform the same exercises at home combined
with 20-40 minutes of aerobic activity two times per week.
Exercise therapy combined with spinal manipulative
therapy (ET + SMT)
Participants in the ET + SMT group participate in the same
ET program described above. In addition, they take part in
8 to 16, 10- to 20-minute sessions of SMT over 12 weeks
(Table 2). Previous research has shown that 9 to 12 treat-
ments are more beneficial than 3 to 6 treatments for adults
with LBP [29]. The number and frequency of treatments
is determined by the individual chiropractor based on
patient-rated symptoms and exam findings [30]. SMT is
provided by experienced chiropractors following standard-
ized treatment protocols. The preferred treatment consists
of a high-velocity, low amplitude thrust SMT. The treating
chiropractor has the option to perform other techniques
(e.g., flexion-distraction, spinal mobilization, or neuromus-
cular techniques) [31], as indicated. Light soft tissue tech-
niques (i.e., active and passive muscle stretching, hot and
cold packs, and ischemic compression of tender points)
may be used as needed to facilitate the manual therapy.
Modification and discontinuation of treatment
Prescription-strength nonsteroidal anti-inflammatory res-
cue medications are available for patients experiencing
severe pain and are prescribed as needed by a study
medical doctor. Any patient who demonstrates progressive
neurological signs or severe intractable pain is removed
from study treatment and referred for orthopedic con-
sultation. Participants who receive medications or are
discontinued from treatment will be included in the
intention-to-treat analyses.
Outcomes
Patient self-report outcomes are collected at the first two
baseline visits and at 4, 8, 12, 26, and 52 weeks after
randomization. The self-report outcomes are based on the
Pediatric Initiative on Methods, Measurement, and Pain
Assessment in Clinical Trials (PedIMMPACT) groupsrec-
ommendations [32]. Objective spinal biomechanical out-
come measures are collected at the first two baseline visits
and at 12 and 26 weeks after study enrollment by examiners
blinded to treatment assignment. The participants physical
activity level is assessed at baseline and at weeks 12 and 26.
Qualitative interviews are conducted at 12 weeks (end of
treatment) to ascertain their perceptions of treatment.
Primary outcome
Pain Patient-rated low back pain at 12, 26, and 52
weeks, measured by the 11-box numerical rating scale, is
the primary outcome measure. LBP at 4 and 8 weeks is
a secondary outcome. Pain severity is regarded as one of
the most important clinical outcomes by adults with
spinal pain [33,34] and is recommended as a core out-
come by an international group of back pain researchers
in addition to the PedIMMPACT group [32,35]. The 11-
box numerical rating scale for pain has been shown to
perform similarly to the visual analogue scale (VAS) in
both pediatric and adult populations [36,37].
Secondary outcomes
Disability Patient-rated disability is assessed using the 18-
item Roland-Morris Disability Questionnaire. The 18-item
Roland-Morris Disability Questionnaire has been shown
to be reliable, valid, and as responsive as the original 24-
item Roland-Morris Disability Questionnaire [38,39].
Quality of life Participants rate their quality of life using
the 23-item PedsQL instrument, which has been devel-
oped to measure physical, emotional, social, and school
functioning domains in children 8 to 18 years old. The
PedsQL is a reliable, valid, and responsive measure of
qualityoflife[40-43].
Improvement Patient-rated improvement is determined
by asking participants to compare their LBP condition to
what it was before study treatment on a 9-point scale
ranging from no symptoms (100% improvement) to as
bad as it could be (100% worse). The caregivers impres-
sion of improvement will also be measured using the
same 9-point scale. Improvement is an important out-
come that has shown to be responsive [44].
Satisfaction The participants overall satisfaction with
care is assessed with a 7-point scale ranging from com-
pletely satisfied (couldnt be better) to completely dissat-
isfied (couldnt be worse). The caregivers satisfaction
with care is also evaluated using the same scale. Re-
search examining global satisfaction with treatment in
pediatric pain trials is lacking and has been identified as
an area of great need by the PedIMMPACT group [32].
Adverse events The complete reporting of adverse
events in clinical trials has received little attention [45].
To address this, we collect adverse event information at
several levels. First, participants are queried about ex-
pected adverse events in the self-report questionnaires
by choosing from a list generated from previous studies
[46,47]. Participants are asked to rate the bothersome-
ness of each adverse event on a 0 to10 scale (0 = not at
all bothersome, 10 = extremely bothersome). In addition,
they are asked about new or ongoing adverse events at
each treatment visit; these are recorded on standardized
treatment notes. Finally, all patients are instructed to a
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report serious adverse event at any time to study staff
(see Data and Safety Monitoring below).
Expectation Participants rate their perception of how
helpful they believe each treatment will be on a 1 to 5 scale
(1 = Much better, 5 = Much worse) prior to randomization.
After randomization, participants are asked to estimate
the degree of improvement they expect to have after 12
weeks of care using the 9-point improvement scale de-
scribed above.
Health care utilization and compliance Patients report
the number of visits and care received from non-study
health care providers. They also report the number of
days they took medication for LBP and performed the
study exercises in the past week.
Qualitative outcomes
Qualitative interviews One-on-one interviews are con-
ducted at 12 weeks. A schedule of questions is used to dir-
ect the interviews and keep the interviewers on a path
consistent with the purpose of the study [48]. The ques-
tions begin broadly, asking how patients felt about the
treatment they received, whether it met their expectations,
and what they liked and disliked. These questions are
followed by probe questions to elicit underlying reasons.
Objective biomechanical outcomes
Continuous lumbar motion Lumbar spinal motion is
assessed using the Zebris CMS-HS Spine Motion Analyzer
(Zebris Inc., Isny im Allgau, Germany), a reliable and accur-
ate measurement system [49,50]. Lumbar flexion-extension,
rotation, and side-bending are examined using a modified
protocol described by Vogt et al [51].
Torso muscle strength & endurance Endurance of the
lower back musculature (trunk flexors, lateral flexors,
and extensors) is examined using the protocol described
by McGill [52]. The tests have been shown to be a valid
and reliable measure of torso muscle endurance [53,54].
Maximum isometric strength of trunk flexors and exten-
sors is measured using a modified standing method de-
scribed by Jørgensen and Nicolaisen [55,56].
Activity level Participantsphysical activity level is
assessed by having them wear a GT3X accelerometer
(Actigraph, Inc. Pensacola, FL) for 7 consecutive days
prior to randomization, then again prior to the week 12
and 26 evaluations. The GT3X accelerometer has been
found to be a reliable and valid measure of physical ac-
tivity level [57].
Analysis plan
For the primary analysis, patient-rated low back pain will
be analyzed at 12, 26, and 52 weeks with linear mixed
model regression to estimate mean differences between
treatment groups at each time point adjusting for baseline
covariates (i.e., rank-order minimization variables) and ac-
counting for correlation across measurements within per-
son. Short- and long-term longitudinal effects between
groups will also be assessed using mixed model analyses
including LBP intensity outcomes from weeks 4 to 12 and
weeks 4 to 52, respectively. Due to the longitudinal study
design, the primary analysis plan was modified from a
one-way analysis of covariance to a linear mixed model ap-
proach to allow increased flexibility when specifying a
variance-covariance structure and accounting for missing
data [58-60]. The analysis plan was modified prior to the
completion of data collection and the start of data analysis.
The variance-covariance structure that best fits the data
will be used to account for correlation among the repeated
measurements within participants [61,62]. Normality as-
sumptions will be evaluated through normal probability
plots and transformations used, if necessary. We will test
for a site-by-group interaction, but given our standard-
ization plan, we do not expect it to be present. Adjusted
mean differences and 95% confidence intervals between
groups for short- and long-term effects based on the final
models will be presented in tables and line graphs. The
need for inclusion of additional covariates to balance base-
line group differences will be evaluated in sensitivity ana-
lysis. Intention-to-treat analysis will be used; all patients
with at least one follow-up measure will be included in the
analysis as the methods do not require data at every time
point. In the event that missing data is present, the pattern
of missingness will be assessed and appropriate imput-
ation and sensitivity analyses will be performed. Re-
sponder analyses (i.e., 50, 75, and 100% pain reduction)
will be conducted to facilitate the interpretation of the
results [63-65].
Power analysis and sample size
The basis for our sample size calculation is the one-way
analysis of covariance (ANCOVA), comparing the pri-
mary outcome (reported pain level at the 12, 26, and 52
week time points) between groups and adjusting for
baseline pain level. We estimated the standard deviation
for change in pain using data from the trial by Jones et
al [18] (SD = 1.4). A conservative R
2
estimate of 0.2 was
used for the sample size calculation. With a power of
0.92 and a 2-group design tested at an alpha level of
0.01, 80 subjects per group are required to detect a pain
reduction of 0.8 points (Power and Precision2.0). We
will allow for a dropout rate/loss to follow-up of up to
15%. Therefore, 92 patients are required per group, for a
total of 184 subjects.
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Data and safety monitoring
The Office of Data Management at Northwestern Health
Sciences University serves as the data coordinating cen-
ter responsible for creation of data collection forms,
coordination of data transfer, and data management. A
Data Safety and Monitoring Committee consisting of
study and non-study clinicians and scientists meet annu-
ally to review the study. Due to the low risk profiles of
the study interventions no interim analyses are planned.
Adverse events are classified using the National Insti-
tutes of Health Office of Human Subjects Research defi-
nitions [66].
Discussion
LBP is a significant health problem not only for adults,
but also for children and adolescents. Given the large so-
cial and economic costs associated with the condition,
identifying effective, conservative management strategies
is critical. While SMT and exercise have been shown to
be effective in adult populations, high quality research is
needed to investigate their effectiveness in adolescent
LBP patients.
Only a limited number of interventions for adolescent
LBP have been evaluated in clinical trials; consequently,
there is no established gold-standardtreatment. We chose
exercise as a core intervention because of the evidence of
effectiveness for adults with LBP [15,16], in addition to the
preliminary evidence in adolescent populations [67]. Fur-
ther, we wanted to encourage active behaviors for the
management of pain in an adolescent population. We hy-
pothesized that adding SMT to a promising treatment like
exercise will produce greater improvements in LBP than
what will be achieved by exercise alone.
Given there have been few studies addressing LBP in
adolescents (and there have been no randomized clinical
trials of SMT), we designed this trial with sufficient meth-
odological rigor to maintain high internal validity; however,
where possible, we also included pragmatic design features
to enhance generalizability [68]. Explanatory design aspects
of the trial aimed at ensuring high validity and low risk of
bias include: the use of multiple baseline assessments to
ensure participant compliance; eligibility criteria to ex-
clude individuals unlikely to demonstrate treatment effects
(e.g., pain intensity 3/10); restricted utilization of co-
interventions during the intervention phase; structured
protocols for the application of the intervention (number
of visits, exercise, or SMT techniques used); application of
the intervention at university-associated research clinics
by clinicians with investigator supervision; and monitoring
of participant and provider compliance including strat-
egies to maximize adherence to study protocols. Pragmatic
features of the study include: multiple recruitment
sources from the general population at multiple sites;
flexibility in the application of the intervention (e.g.,
exercise progressions, type of SMT used) based on indi-
vidual patient needs and abilities; the use of an active
treatment comparison group; the collection of both short-
and long-term outcomes; and the plan to use intention-to-
treat statistical analysis.
Upon completion, this study will provide high quality
scientific evidence regarding SMT and exercise for LBP
in adolescents with the potential to alter clinical practice
and reduce both the current and future burden of LBP.
Competing interests
The authors declare that they have no competing interests.
Authorscontributions
GB and MH are the co-principal investigators and have been primarily
responsible for study conception, design, analysis plan, funding acquisition and
implementation. CS, DP, DV, and RE contributed to the conceptualization and
design of the study, funding acquisition, and implementation. BL participated in
the implementation and management of the trial, drafted the Background,
Methods, and Discussion sections of the manuscript, and coordinated
manuscript preparation and revision. All authors provided critical evaluation and
revision of the manuscript and have given final approval of the manuscript
accepting responsibility for all aspects.
Acknowledgements
The trial was funded by the U.S. Department of Health and Human Services
Health Resources and Services Administration (HRSA), Bureau of Health
Professions (BHPr), Division of Medicine and Dentistry (DMD), grant number
R18HP15124. The content and conclusions of this manuscript are those of
the authors and should not be construed as the official position or policy of,
nor should any endorsements be inferred by the U.S. government, HHS,
HRSA, BHPr, or the DMD.
The authors wish to acknowledge the contributions of our dedicated project
managers Kayla Kelly and Sarah Kirkpatrick, in addition to the research
clinicians and staff.
Author details
1
Wolfe-Harris Center for Clinical Studies, Northwestern Health Sciences
University, 2501 W 84th St, Bloomington, MN 55431, USA.
2
Center for
Outcome Studies, University of Western States, 2900 NE 132nd Ave, Portland,
OR 97230, USA.
3
Division of Chiropractic Sciences, University of Western
States, 2900 NE 132nd Ave, Portland, OR 97230, USA.
Received: 31 January 2014 Accepted: 11 April 2014
Published: 23 May 2014
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doi:10.1186/2045-709X-22-21
Cite this article as: Schulz et al.:Spinal manipulation and exercise for low
back pain in adolescents: study protocol for a randomized controlled trial.
Chiropractic & Manual Therapies 2014 22:21.
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... Each of the included trials obtained written consent from participants who were 18 years of age or older, and written patient assent and parent consent from participants 12-17 years of age. Six of the clinical trials were funded by the U.S. Department of Health and Human Services Health Resources and Services Administration [22][23][24][25][26][27] and one was funded by the National Institute of Health's National Center for Complementary and Integrative Health [28]. Seven of the trials are registered on clinicaltrials.gov ...
... All of the clinical trials were performed within a university-affiliated research clinic in the Minneapolis, MN metropolitan region. Six of the clinical trials were performed exclusively in MN [22-25, 28, 29] and two were multi-center studies with additional sites in Portland, OR [27] or Davenport, IA [26]. Participants had commonly recognized sub-groups of spinal pain including acute or chronic neck pain, chronic low back pain, and back-related leg pain ( Table 1). ...
... Supervised exercise therapy was delivered by licensed chiropractors, physical therapists or exercise therapists over an [11][12] week period in six trials. Five studies [22][23][24][25]29] included 20 one-hour visits and one trial [27] included 8 to16, 45-min visits of one-on-one supervised exercise therapy [25,29]. Participants completed a combination of stretching and strengthening exercises emphasizing a high number of repetitions with progressions in challenge and/or resistance over time. ...
Article
Full-text available
Background Spinal pain is a common and disabling condition with considerable socioeconomic burden. Spine pain management in the United States has gathered increased scrutiny amidst concerns of overutilization of costly and potentially harmful interventions and diagnostic tests. Conservative interventions such as spinal manipulation, exercise and self-management may provide value for the care of spinal pain, but little is known regarding the cost-effectiveness of these interventions in the U.S. Our primary objective for this project is to estimate the incremental cost-effectiveness of spinal manipulation, exercise therapy, and self-management for spinal pain using an individual patient data meta-analysis approach. Methods/design We will estimate the incremental cost-effectiveness of spinal manipulation, exercise therapy, and self-management using cost and clinical outcome data collected in eight randomized clinical trials performed in the U.S. Cost-effectiveness will be assessed from both societal and healthcare perspectives using QALYs, pain intensity, and disability as effectiveness measures. The eight randomized clinical trials used similar methods and included different combinations of spinal manipulation, exercise therapy, or self-management for spinal pain. They also collected similar clinical outcome, healthcare utilization, and work productivity data. A two-stage approach to individual patient data meta-analysis will be conducted. Discussion This project capitalizes on a unique opportunity to combine clinical and economic data collected in a several clinical trials that used similar methods. The findings will provide important information on the value of spinal manipulation, exercise therapy, and self-management for spinal pain management in the U.S.
... A detailed description of the full study protocol was published previously. [53] The study was funded by the U.S. Department of Health and Human Services and was registered at clinicaltrials.gov (NCT01096628) This was a two-site, parallel-group randomized controlled trial that used allocation by rank-order minimization. ...
... 8] Detailed descriptions of the interventions are provided in a previous publication. [53] ...
... The primary outcomes were group differences in pain severity at weeks 12, 26, and 52 derived from the linear mixed effect model. Prior to conducting the analysis, the following strategy was agreed-upon by the statistician to control for multiple endpoints, but was not described previously in the protocol [53]. We used Fisher's protected least significant difference approach [38] to control for the repeated measures. ...
Article
Low back pain (LBP) is common in adolescence but there is a paucity of high quality research to inform care. We conducted a multicenter randomized trial comparing 12 weeks of spinal manipulative therapy (SMT) combined with exercise therapy (ET) to ET alone.Participants were 185 adolescents aged 12-18 years with chronic LBP.The primary outcome was LBP severity at 12, 26, and 52 weeks. Secondary outcomes included disability, quality of life, medication use, patient and caregiver-rated improvement and satisfaction. Outcomes were analyzed using longitudinal linear mixed effect models. An omnibus test assessing differences in individual outcomes over the entire year controlled for multiplicity.Of the 185 enrolled patients, 179 (97%) provided data at 12 weeks and 174 (94%) at 26 and 52 weeks. Adding SMT to ET resulted in a larger reduction in LBP severity over the course of one year (P=0.007). The group difference in LBP severity (0-10 scale) was small at the end of treatment (mean difference=0.5; P=0.08), but was larger at weeks 26 (mean difference=1.1; P=0.001) and 52 (mean difference=0.8; P=0.009). At 26 weeks, SMT with ET performed better than ET alone for disability (P=0.04) and improvement (P=0.02). The SMT with ET group reported significantly greater satisfaction with care at all time points (P≤0.02). There were no serious treatment-related adverse events.For adolescents with chronic LBP, spinal manipulation combined with exercise was more effective than exercise alone over a one-year period, with the largest differences occurring at six months. These findings warrant replication and evaluation of cost-effectiveness.
... Patients had the opportunity to participate in the trial if they suffered for >3 months with a history of chronic nonspecific low back pain, were aged between 18 and 60 years, and PI ≥3 on 0-10 Numeric Pain Rating Scale (NPRS). Participants were excluded if they have a baseline pain score of fewer than 3 points, [24] pain referred from the lumbar to the lower extremities, serious spinal disorder, including malignancy, osteoporosis, ankylosing spondylitis, cauda equina compression and infection, previous spinal surgery, fracture of vertebrae, and administered epidural injection. ...
... The study protocol for the parent RCT has been published. 18 A sample of 143 participants recruited and enrolled at a single site (university-associated research clinic in Bloomington, MN) within a 2-site RCT was used for this secondary analysis. Eligible participants were 12 to 18 years of age with subacute recurrent or chronic LBP and a self-rated pain intensity (typical level during the past week) of 3 or greater on a 0-to-10 numeric rating scale (NRS). ...
Article
Study Design Cross-sectional. Background Although low back pain (LBP) occurs commonly in adolescence, little is known about the relationship between objectively measured physical activity and chronic LBP. Objectives Assess the relationship between objective physical activity measures assessed by accelerometers and standard clinical measures (pain intensity, disability, quality of life) in a sample of adolescents with recurrent or chronic LBP. Methods The study used a sub-sample of 143 adolescents, 12 - 18 years of age, from a randomized clinical trial. Pearson's correlation (r) and bivariate linear regression were used to assess the relationship between baseline measures of sedentary, light, and moderate-to-vigorous physical activity using accelerometers and clinical measures of LBP (pain intensity, disability, and quality of life). Results Adolescents spent an average of 610.5 minutes in sedentary activity, 97.6 minutes in light physical activity, and 35.6 minutes in moderate-to-vigorous physical activity per day. Physical activity was very weakly associated with clinical measures of LBP (|r| < 0.13). None of the assessed correlations were statistically significant and bivariate regression models showed physical activity measures explained very little of the variability for clinical measures of LBP (R(2) < 0.02). Conclusion We found no important relationship between objectively measured physical activity and self-reported LBP intensity, disability, or quality of life in adolescents with recurrent or chronic LBP. J Orthop Sports Phys Ther, Epub 12 Sep 2017. doi:10.2519/jospt.2017.7345.
... Cervical kinematics These are evaluated using the Zebris CMS-HS Spine Motion Analyzer (Zebris Inc., Isny im Allgau, Germany) and a modified protocol described by Wang [46]. This reliable and accurate tool has been used in other RCTs [46][47][48][49]. Flexion, extension, lateral flexion and rotation, coupled out of plane motion, and maximum accelerations and velocities in these planes are recorded. ...
Article
Full-text available
Background Cervicogenic headache is a prevalent and costly pain condition commonly treated by chiropractors. There is evidence to support the effectiveness for spinal manipulation, but the dose of treatment required to achieve maximal relief remains unknown. The purpose of this paper is to describe the methodology for a randomized controlled trial evaluating the dose–response of spinal manipulation for chronic cervicogenic headache in an adult population. Methods/Design This is a mixed-methods, two-site, prospective, parallel groups, observer-blind, randomized controlled trial conducted at university-affiliated research clinics in the Portland, OR and Minneapolis, MN areas. The primary outcome is patient reported headache frequency. Other outcomes include self-reported headache intensity, disability, quality of life, improvement, neck pain intensity and frequency, satisfaction, medication use, outside care, cervical motion, pain pressure thresholds, health care utilization, health care costs, and lost productivity. Qualitative interviews are also conducted to evaluate patients’ expectations of treatment. Discussion With growing concerns regarding the costs and side effects of commonly used conventional treatments, greater numbers of headache sufferers are seeking other approaches to care. This is the first full-scale randomized controlled trial assessing the dose–response of spinal manipulation therapy on outcomes for cervicogenic headache. The results of this study will provide important evidence for the management of cervicogenic headache in adults. Trial registration ClinicalTrials.gov (Identifier: NCT01530321)
... 1 The treatment of children with SMT is controversial within the medical community, primarily with respect to adverse events. 71,74 Chiropractic management of pediatric patients, often including manipulation, is well documented and has demonstrated favorable results. 2,3,11,24,36,38,73,75 However, there are few papers evaluating SMT in the physical therapy setting. ...
Article
Study Design Case series. Background Low back pain (LBP) is an increasing problem in health care. The evidence is minimal for using spinal manipulative therapy to treat pediatric patients with LBP. The treatment of pediatrics with manual therapy, particularly spinal manipulation, is controversial within the medical community primarily with respect to adverse events. The purpose of this case series is to illustrate the feasibility and safety of lumbar manipulation plus exercise in the adolescent population with mechanical LBP. Case Description Three patients; a 13-year old female, 15-year old female, and 13-year old male were treated in an outpatient physical therapy setting for mechanical LBP. All three patients were assessed using a lumbar manipulation clinical prediction rule and treated with side-lying lumbar manipulation and exercise. Outcomes Patients were treated for a total of 10 to 14 visits over a course of 8 to 9 weeks. Pain, as measured by the Numerical Pain Rating Scale, and disability, measured by the Modified Oswestry Disability Index, improved to 0/10 and measured 0%, respectively, in each patient. No adverse reactions to manipulation were reported. Discussion The results of this case series describe the use of lumbar thrust manipulation and exercise for the treatment of mechanical LBP in adolescents. The positive results indicate lumbar manipulation may potentially be a safe adjunct therapy. Further studies, including randomized control trials, are needed to determine effectiveness. Level of Evidence Therapy, level 4. J Orthop Sports Phys Ther, Epub 6 Apr 2016. doi:10.2519/jospt.2016.6366.
Article
Full-text available
ABSTRACT Introduction: Spinal manipulation is a technique of specific directed manual thrust which has been effective in aligning a spinal segment, maintaining normal range of motion and reducing pain. Recent studies have reported on management of pain and improvement of quality of life of patients suffering from mechanical low back pain. Aim: To analyse the effectiveness of Spinal Manipulation-High- Velocity Low Amplitude Thrust (SM-HVLA) on pain sensitivity, postural sway and quality of life in patients with Chronic Non-Specific Low Back Pain (CNSLBP). Materials and Methods: This randomised controlled trial was conducted on a sample size of 90 patients with chronic non-specific low back pain (with duration of pain more than three months) recruited from Outpatient Department, Department of Physiotherapy, Lovely Professional University, Phagwara, Punjab, India. Participants were divided into three groups, namely Control Group, Study Group-1, and Study Group-2. Control group received supervised exercise with ergonomic advice (n=30), whereas SM-HVLA thrust with ergonomic advice (n=30), and study group-2 received core stability exercise with ergonomic advice (n=30). Primary outcomes were postural sways (centres of foot pressure) measured by Win Track Platform, and pain sensitivity measured by pressure pain threshold (digital algometer) and quality of life measured by EuroQoL questionnaire score at two weeks and four weeks. Univariate analysis of variance (ANOVA) with post-hoc Tukey’s multiple comparison tests was carried out to examine treatment effects and the relationship between groups changes across outcome measures. Results: For all three treatment groups, outcomes improved after two weeks of treatment. The group received spinal manipulation with ergonomic advice had slightly better outcome than the supervised exercise with ergonomic advice group at two weeks (between-group difference) in pain sensitivity (p=0.001); Postural sway (p=0.001); quality of life (p=0.01) as well as at four weeks (between-group difference): pain sensitivity (p=0.001); postural sway (p=0.001); quality of life (p=0.01). Conclusion: The spinal manipulation with ergonomic advice is effective in treatment of chronic non-specific low back pain. This is an economic model of back care in clinics can be practised widely.
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O uso da TENS para tratamento da espasticidade decorrente do acidente vascular encefálico (AVE) tem sido alvo de muitas pesquisas. O objetivo do trabalho é analisar por meio de uma revisão de literatura a eficácia da aplicação da TENS para a redução da espasticidade em pacientes após AVE. Realizada pesquisa em bancos de dados online (Medline/PubMed, Scielo e Lilacs) onde foram encontrados 58 artigos abordando o tema, porém apenas 10 se encaixaram nos critérios de inclusão, delimitados entre os anos de 2000 a 2014. Foi observada escassez de estudos que abordassem o tema, sendo verificado o emprego das mais variadas modalidades da TENS, indicando que a técnica é favorável na redução da espasticidade. A TENS parece confiável para reduzir a espasticidade decorrente do AVE, porém seus parâmetros ainda não foram bem estabelecidos. Assim, mais ensaios clínicos são necessários.
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Background Reviews indicate that the quality of reporting of randomised controlled trials (RCTs) in the medical literature is less than optimal, poor to moderate, and require improving. However, the reporting quality of chiropractic RCTs is unknown.As a result, the aim of this study was to assess the reporting quality of chiropractic RCTs and identify factors associated with better reporting quality. We hypothesized that quality of reporting of RCTs was influenced by industry funding, positive findings, larger sample sizes, latter year of publication and publication in non-chiropractic journals. MethodsRCTs published between 2005 and 2014 were sourced from clinical trial registers, PubMed and the Cochrane Reviews. RCTs were included if they involved high-velocity, low-amplitude (HVLA) spinal and/or extremity manipulation and were conducted by a chiropractor or within a chiropractic department. Data extraction, and reviews were conducted by all authors independently. Disagreements were resolved by consensus. Outcomes: a 39-point overall quality of reporting score checklist was developed based on the CONSORT 2010 and CONSORT for Non-Pharmacological Treatments statements. Four key methodological items, based on allocation concealment, blinding of participants and assessors, and use of intention-to-treat analysis (ITT) were also investigated. ResultsThirty-five RCTs were included. The overall quality of reporting score ranged between 10 and 33 (median score 26.0; IQR = 8.00). Allocation concealment, blinding of participants and assessors and ITT analysis were reported in 31 (87 %), 16 (46 %), 25 (71 %) and 21 (60 %) of the 35 RCTs respectively. Items most underreported were from the CONSORT for Non-Pharmacological Treatments statement. Multivariate regression analysis, revealed that year of publication (t32 = 5.17, p = 0.000, 95 % CI: 0.76, 1.76), and sample size (t32 = 3.01, p = 0.005, 95 % CI: 1.36, 7.02), were the only two factors associated with reporting quality. Conclusion The overall quality of reporting RCTs in chiropractic ranged from poor to excellent, improving between 2005 and 2014. This study suggests that quality of reporting, was influenced by year of publication and sample size but not journal type, funding source or outcome positivity. Reporting of some key methodological items and uptake of items from the CONSORT Extension for Non-Pharmacological Treatments items was suboptimal. Future recommendations were made.
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In controlled clinical trials, the treatments are likely to be influenced by various prognostic factors, and while assigning treatments sequentially to the patients it is desirable to allot the treatments in such a way that the treatments are balanced over the main effects of prognostic factors and also on some or all interactions between the prognostic factors if the interactions are present. Efran (1971), Pocock and Simon (1975) and Freedman and White (1976) described some methods of balancing the treatments over the prognostic factors. In this paper, we shall describe a new approach in assigning the treatments using multivariate methods.
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Study Design. An international group of back pain researchers considered recommendations for standardized measures in clinical outcomes research in patients with back pain. Objectives. To promote more standardization of outcome measurement in clinical trials and other types of outcomes research, including meta‐analyses, cost‐effectiveness analyses, and multicenter studies. Summary of Background Data. Better standardization of outcome measurement would facilitate comparison of results among studies, and more complete reporting of relevant outcomes. Because back pain is rarely fatal or completely cured, outcome assessment is complex and involves multiple dimensions. These include symptoms, function, general well‐being, work disability, and satisfaction with care. Methods. The panel considered several factors in recommending a standard battery of outcome measures. These included reliability, validity, responsiveness, and practicality of the measures. In addition, compatibility with widely used and promoted batteries such as the American Academy of Orthopaedic Surgeons Lumbar Cluster were considered to minimize the need for changes when these instruments are used. Results. First, a six‐item set was proposed, which is sufficiently brief that it could be used in routine care settings for quality improvement and for research purposes. An expanded outcome set, which would provide more precise measurement for research purposes, includes measures of severity and frequency of symptoms, either the Roland or the Oswestry Disability Scale, either the SF‐12 or the EuroQol measure of general health status, a question about satisfaction with symptoms, three types of "disability days," and an optional single item on overall satisfaction with medical care. Conclusion. Standardized measurement of outcomes would facilitate scientific advances in clinical care. A short, 6‐item questionnaire and a somewhat expanded, more precise battery of questionnaires can be recommended. Although many considerations support such recommendations, more data on responsiveness and the minimally important change in scores are needed for most of the instruments.
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