Craniosacral Therapy to Treat Chronic Low Back Pain

Study Overview
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Brief Summary
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The purpose of this study is to determine whether a craniosacral therapy program are effective on disability, quality of life, autonomic nervous system and oxidative stress indicators in patients with chronic low back pain.

Detailed Description
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Design: Randomized clinical trial. Objective: to determine the effectiveness of a craniosacral therapy program on disability, quality of life, autonomic nervous system, body mass, hormonal indicators, spinal projection, and oxidative stress indicators in patients with chronic low back pain. Participants: Seventy patients with chronic non-specific low back pain will be randomly assigned to an experimental and control group. Intervention: For 10-week, the experimental group will undergo treatment comprising 10 sessions (1/week) of a craniosacral therapy program with ten techniques, and the control group will receive only one craniosacral technique. Main Outcome Measures: disability, quality of life, biochemical estimation interstitial fluid, body mass indicators, hormonal indicators, indicators of autonomic nervous system,and indicators of oxidative stress will be collected in both groups at baseline, 10 weeks and 15 weeks after the last intervention in the experimental and control groups, by an assessor blinded to the treatment allocation of the patients. Baseline demographic and clinical variables will be examined between both groups with an independent Student t-test for continuous data. Separate 2x3 model ANOVA with time (baseline, 10 weeks and 15 weeks) as the within-subjects factor, group (experimental, control) will be to determine the effects of the treatment.

Official Title
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Effectiveness of a Craniosacral Therapy Program on Disability, Quality of Life, Autonomic Nervous System and Oxidative Stress Indicators in Chronic Low Back Pain: a Randomized Controlled Clinical Trial

Conditions
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Low Back Pain

Intervention / Treatment
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* Other: Craniosacral Therapy Program
* Other: One technique of craniosacral therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Low back pain for > 3 months Score > 4 on the Roland Morris Disability questionnaire No undergoing another physical therapy treatment Exclusion Criteria: Clinical signs of radiculopathy Presence of lumbar stenosis Fibromyalgia Spondylolisthesis History of spinal surgery Treatment with corticosteroids in the past two weeks Disease of the central or peripheral nervous system

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Craniosacral Therapy Program<br>A program of 10 craniosacral therapy techniques | Other: Craniosacral Therapy Program<br>* The ten techniques of craniosacral therapy program are: Still Point (CV-4, Sacred Feet), diaphragms(pelvic, respiratory, thoracic inlet, hyoid, Occipital Cranial Base), Decompression L5-S1, Dural Tube Glide, Lift Front, Parietal Lift, Compression / decompression of the joint sphenobasilar, Temporary Technique, Compression / decompression of the temporomandibular joints, and Still Point CV-4.<br>|
| Active Comparator: One technique of craniosacral therapy<br>Decompression L5-S1. | Other: One technique of craniosacral therapy<br>* Decompression L5-S1: lumbosacral decompression<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change for the Roland Morris Disability Questionnaire | The Roland Morris Disability Questionnaire is a self-administered disability measurement scored on a 24-point scale from 0 = no disability to 24 = severe disability | At baseline, 10 weeks and 15 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change for the Lifestyle indicators | Estimation interstitial fluid biochemistry and measure the following indicators: body mass, hormonal, autonomic nervous system and oxidative stress. | At baseline, 10 weeks and 15 weeks | 
| Change on Neural Network Analysis | Analysis of the projection on the spine and segmental innervation projection | At baseline, 10 weeks and 15 weeks | 
| Change on Quality of Life | SF-36 Health questionnaire scores range from 0 to 100% and indicate the self-perceived health-related quality of life | At baseline, 10 weeks and 15 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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low back pain, Manual Therapy, Randomized Controlled Trial, Quality of life