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Spinal manipulation and exercise for low back pain in adolescents: study protocol for a randomized controlled trial.

ABSTRACT: 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.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.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.(ClinicalTrials.gov NCT01096628).

SUBMITTER: Schulz C

PROVIDER: S-EPMC4046145 | biostudies-literature | 2014

REPOSITORIES: biostudies-literature

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Spinal manipulation and exercise for low back pain in adolescents: study protocol for a randomized controlled trial.

Schulz Craig C Leininger Brent B Evans Roni R Vavrek Darcy D Peterson Dave D Haas Mitchell M Bronfort Gert G

Chiropractic & manual therapies 20140523

<h4>Background</h4>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 ...[more]

PMID: 24904748

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Project description:There have been no full-scale trials of the optimal number of visits for the care of any condition with spinal manipulation.To identify the dose-response relationship between visits to a chiropractor for spinal manipulation and chronic low back pain (cLBP) outcomes and to determine the efficacy of manipulation by comparison with a light massage control.Practice-based randomized controlled trial.Four hundred participants with cLBP.The primary cLBP outcomes were the 100-point modified Von Korff pain intensity and functional disability scales evaluated at the 12- and 24-week primary end points. Secondary outcomes included days with pain and functional disability, pain unpleasantness, global perceived improvement, medication use, and general health status.One hundred participants with cLBP were randomized to each of four dose levels of care: 0, 6, 12, or 18 sessions of spinal manipulation from a chiropractor. Participants were treated three times per week for 6 weeks. At sessions when manipulation was not assigned, they received a focused light massage control. Covariate-adjusted linear dose effects and comparisons with the no-manipulation control group were evaluated at 6, 12, 18, 24, 39, and 52 weeks.For the primary outcomes, mean pain and disability improvement in the manipulation groups were 20 points by 12 weeks and sustainable to 52 weeks. Linear dose-response effects were small, reaching about two points per six manipulation sessions at 12 and 52 weeks for both variables (p<.025). At 12 weeks, the greatest differences from the no-manipulation control were found for 12 sessions (8.6 pain and 7.6 disability points, p<.025); at 24 weeks, differences were negligible; and at 52 weeks, the greatest group differences were seen for 18 visits (5.9 pain and 8.8 disability points, p<.025).The number of spinal manipulation visits had modest effects on cLBP outcomes above those of 18 hands-on visits to a chiropractor. Overall, 12 visits yielded the most favorable results but was not well distinguished from other dose levels.

Project description:UNLABELLED: BACKGROUND:This pilot randomized controlled trial evaluated the feasibility of conducting a full scale study and compared the efficacy of exercise, spinal manipulation, and a mind-body therapy called Neuro Emotional Technique for the treatment of pregnancy-related low back pain, a common morbidity of pregnancy. METHODS:Healthy pregnant women with low back pain of insidious onset were eligible to enroll in the study at any point in their pregnancy. Once enrolled, they remained in the study until they had their babies. Women were randomly allocated into one of three treatment groups using opaque envelopes. The treatment schedule paralleled the prenatal care schedule and women received individualized intervention. Our null hypothesis was that spinal manipulation and Neuro Emotional Technique would perform no better than exercise in enhancing function and decreasing pain. Our primary outcome measure was the Roland Morris Disability Questionnaire and our secondary outcome measure was the Numeric Pain Rating Scale. Intention to treat analysis was conducted. For the primary analysis, regression was conducted to compare groups on the outcome measure scores. In a secondary responder analysis, difference in proportions of participants in attaining 30% and 50% improvement were calculated. Feasibility factors for conducting a future larger trial were also evaluated such as recruitment, compliance to study protocols, cost, and adverse events. RESULTS:Fifty-seven participants were randomized into the exercise (n?=?22), spinal manipulation (n?=?15), and Neuro Emotional Technique (n?=?20) treatment arms. At least 50% of participants in each treatment group experienced clinically meaningful improvement in symptoms for the Roland Morris Disability Questionnaire. At least 50% of the exercise and spinal manipulation participants also experienced clinically meaningful improvement for the Numeric Pain Rating Scale. There were no clinically meaningful or statistically significant differences between groups in any analysis. CONCLUSIONS:This pilot study demonstrated feasibility for recruitment, compliance, safety, and affordability for conducting a larger study in the future. Spinal manipulation and exercise generally performed slightly better than did Neuro Emotional Technique for improving function and decreasing pain, but the study was not powered to detect the between-group differences as statistically significant. TRIAL REGISTRATION:ClinicalTrials.gov (Identifier: NCT00937365).

Project description:IntroductionExercise therapy is the most recommended treatment for chronic low back pain (LBP). Effect sizes for exercises are usually small to moderate and could be due to the heterogeneity of people presenting with LBP. Thus, if patients could be better matched to exercise based on individual factors, then the effects of treatment could be greater. A recently published study provided evidence of better outcomes when patients are matched to the appropriate exercise type. The study demonstrated that a 15-item questionnaire, the Lumbar Spine Instability Questionnaire (LSIQ), could identify patients who responded best to one of the two exercise approaches for LBP (motor control and graded activity). The primary aim of the current study isill be to evaluate whether preidentified baseline characteristics, including the LSIQ, can modify the response to two of the most common exercise therapies for non-specific LBP. Secondary aims include an economic evaluations with a cost-effectiveness analysis.Methods and analysisParticipants (n=414) will be recruited by primary care professionals and randomised (1:1) to receive motor control exercises or graded activity. Participants will undergo 12 sessions of exercise therapy over an 8-week period. The primary outcome will be physical function at 2 months using the Oswestry Disability Index. Secondary outcomes will be pain intensity, function and quality of life measured at 2, 6 and 12 months. Potential effect modifiers will be the LSIQ, self-efficacy, coping strategies, kinesiophobia and measures of nociceptive pain and central sensitisation. We will construct linear mixed models with terms for participants (fixed), treatment group, predictor (potential effect modifier), treatment group×predictor (potential effect modifier), physiotherapists, treatment group×physiotherapists and baseline score for the dependent variable.Ethics and disseminationThis study received ethics approval from the Hamilton Integrate Research Ethics Board. Results will be submitted for publication in peer-reviewed journals.Trial registration numberNCT04283409.

Project description:BackgroundPain hypersensitivity can be assessed using Quantitative Sensory Testing (QST) and is associated with persistent low back pain. Spinal manipulation appears to modify pain hypersensitivity, and this could function as one mechanism leading to clinical improvements. In the current study, we applied a comprehensive QST battery to assess pain sensitivity in a cohort of low back pain patients before and after spinal manipulation to improve our understanding of the association between QST and clinical improvements. This study addresses two questions: Are clinical improvements following spinal manipulation in low back pain patients contingent on pain hypersensitivity, and does pain sensitivity change following spinal manipulation?MethodsWe performed a secondary analysis of data from a randomized clinical trial. One hundred and thirty-two participants with persistent LBP were treated with spinal manipulation four times over two weeks. Patient-reported outcomes and QST were assessed at baseline, after the fourth spinal manipulation session, and 14-days later. The clinical outcomes were changes in low back pain intensity and disability. Using latent profile analysis, we categorized the participants into clusters depending on their baseline QST scores. We used linear mixed models to examine the association between clusters and changes in patient-reported outcomes and QST.ResultsTwo clusters emerged: a Sensitized and a Not sensitized. The former had significantly lower regional pressure and thermal pain thresholds, remote pressure pain tolerance, and lower inhibitory conditioned pain modulation than the Not sensitized group. However, we only found between-cluster differences for regional pressure pain threshold following spinal manipulation. Thus, the clusters were not associated with patient-reported pain and disability changes or the remaining QST outcomes.ConclusionsWe report that the baseline QST profile was not associated with clinical improvements following spinal manipulation. We did observe a substantial change for regional pressure pain threshold, which suggests that any effect of spinal manipulation on pain sensitivity is most likely to be observed as changes in regional, mechanical pain threshold. However, the mechanism that invokes clinical improvement and pain sensitivity changes appear distinct. Due to methodological caveats, we advise caution when interpreting the results.Trial registrationClinical.Trial.gov identifier: NCT04086667 , registered 11 September 2019 - Retrospectively registered, https://clinicaltrials.gov/ct2/show/NCT04086667.

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Spinal manipulation and exercise for low back pain in adolescents: study protocol for a randomized controlled trial.

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Spinal manipulation and exercise for low back pain in adolescents: study protocol for a randomized controlled trial.

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