Craniosacral Therapy to Treat Chronic Low Back Pain
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|ClinicalTrials.gov Identifier: NCT01822236|
Recruitment Status : Completed
First Posted : April 2, 2013
Last Update Posted : March 25, 2015
|Condition or disease||Intervention/treatment||Phase|
|Low Back Pain||Other: Craniosacral Therapy Program Other: One technique of craniosacral therapy||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||70 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||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|
|Study Start Date :||April 2013|
|Actual Primary Completion Date :||December 2013|
|Actual Study Completion Date :||December 2013|
Experimental: Craniosacral Therapy Program
A program of 10 craniosacral therapy techniques
Other: Craniosacral Therapy Program
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.
Active Comparator: One technique of craniosacral therapy
Other: One technique of craniosacral therapy
Decompression L5-S1: lumbosacral decompression
- Change for the Roland Morris Disability Questionnaire [ Time Frame: At baseline, 10 weeks and 15 weeks ]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
- Change for the Lifestyle indicators [ Time Frame: At baseline, 10 weeks and 15 weeks ]Estimation interstitial fluid biochemistry and measure the following indicators: body mass, hormonal, autonomic nervous system and oxidative stress.
- Change on Neural Network Analysis [ Time Frame: At baseline, 10 weeks and 15 weeks ]Analysis of the projection on the spine and segmental innervation projection
- Change on Quality of Life [ Time Frame: At baseline, 10 weeks and 15 weeks ]SF-36 Health questionnaire scores range from 0 to 100% and indicate the self-perceived health-related quality of life
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01822236
|Universidad de Almeria|
|Almeria, Spain, 04120|
|Study Director:||Adelaida Castro-Sánchez, PhD||Universidad de Almeria|