NCT01822236

Craniosacral Therapy to Treat Chronic Low Back Pain

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 70 (actual)
• Sponsor: Universidad de Almeria · Academic / Other
• Sex: All
• Age: 25 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Low Back Pain

Interventions

Type	Name	Description
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.
OTHER	One technique of craniosacral therapy	Decompression L5-S1: lumbosacral decompression

Timeline

• Start date: 2013-04-01
• Primary completion: 2013-12-01
• Completion: 2013-12-01
• First posted: 2013-04-02
• Last updated: 2015-03-25

Locations

1 site across 1 country: Spain