Craniosacral Therapy to Treat Chronic Low Back Pain

Not Applicable

Completed

• Conditions: Low Back Pain
• Interventions: Other: Craniosacral Therapy Program; Other: One technique of craniosacral therapy

• Registration Number: NCT01822236
• Lead Sponsor: Universidad de Almeria

Brief 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.

Study Timeline

• Study First Submitted: 2013-03-24
• Study First Submitted QC: 2013-03-27
• Study Start: 2013-04
• Study First Posted: 2013-04-02
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-23
• Last Update Posted: 2015-03-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

• Low back pain for > 3 months
• Score > 4 on the Roland Morris Disability questionnaire
• No undergoing another physical therapy treatment

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Craniosacral Therapy Program	Craniosacral Therapy Program	A program of 10 craniosacral therapy techniques
One technique of craniosacral therapy	One technique of craniosacral therapy	Decompression L5-S1.

Primary Outcome Measures

Name	Time	Method
Change for the Roland Morris Disability Questionnaire	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

Secondary Outcome Measures

Name	Time	Method
Change for the Lifestyle indicators	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 Quality of Life	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
Change on Neural Network Analysis	At baseline, 10 weeks and 15 weeks	Analysis of the projection on the spine and segmental innervation projection

Trial Locations

Locations (1)

Universidad de Almeria; 🇪🇸 Almeria, Spain