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Craniosacral Therapy to Treat Chronic Low Back Pain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01822236
Recruitment Status : Completed
First Posted : April 2, 2013
Last Update Posted : March 25, 2015
Sponsor:
Collaborator:
Universidad de Granada
Information provided by (Responsible Party):
Adelaida María Castro-Sánchez, 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.

Condition or disease Intervention/treatment Phase
Low Back Pain Other: Craniosacral Therapy Program Other: One technique of craniosacral therapy Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain

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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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.

  2. 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

  3. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Locations
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Spain
Universidad de Almeria
Almeria, Spain, 04120
Sponsors and Collaborators
Universidad de Almeria
Universidad de Granada
Investigators
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Study Director: Adelaida Castro-Sánchez, PhD Universidad de Almeria
Publications:

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Responsible Party: Adelaida María Castro-Sánchez, PhD (Lecturer), Universidad de Almeria
ClinicalTrials.gov Identifier: NCT01822236    
Other Study ID Numbers: UAL-123
First Posted: April 2, 2013    Key Record Dates
Last Update Posted: March 25, 2015
Last Verified: March 2015
Keywords provided by Adelaida María Castro-Sánchez, Universidad de Almeria:
low back pain
Manual Therapy
Randomized Controlled Trial
Quality of life
Additional relevant MeSH terms:
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Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Signs and Symptoms