Craniosacral Therapy to Treat Chronic Low Back Pain

March 23, 2015 updated by: Adelaida María Castro-Sánchez, Universidad de Almeria

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Almeria, Spain, 04120
        • Universidad de Almeria

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
Decompression L5-S1.
Other: One technique of craniosacral therapy
Decompression L5-S1: lumbosacral decompression

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
At baseline, 10 weeks and 15 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
At baseline, 10 weeks and 15 weeks
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
At baseline, 10 weeks and 15 weeks
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
At baseline, 10 weeks and 15 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad de Almeria

Collaborators

Universidad de Granada

Investigators

  • Study Director: Adelaida Castro-Sánchez, PhD, Universidad de Almeria

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2013

Primary Completion (Actual)

December 1, 2013

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

March 24, 2013

First Submitted That Met QC Criteria

March 27, 2013

First Posted (Estimate)

April 2, 2013

Study Record Updates

Last Update Posted (Estimate)

March 25, 2015

Last Update Submitted That Met QC Criteria

March 23, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UAL-123

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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