search
Back to results

Craniosacral Therapy to Treat Chronic Low Back Pain

Primary Purpose

Low Back Pain

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Craniosacral Therapy Program
One technique of craniosacral therapy
Sponsored by
Universidad de Almeria
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain focused on measuring low back pain, Manual Therapy, Randomized Controlled Trial, Quality of life

Eligibility Criteria

25 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Universidad de Almeria

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Craniosacral Therapy Program

One technique of craniosacral therapy

Arm Description

A program of 10 craniosacral therapy techniques

Decompression L5-S1.

Outcomes

Primary Outcome Measures

Change for the Roland Morris Disability Questionnaire
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

Change for the Lifestyle indicators
Estimation interstitial fluid biochemistry and measure the following indicators: body mass, hormonal, autonomic nervous system and oxidative stress.
Change on Neural Network Analysis
Analysis of the projection on the spine and segmental innervation projection
Change on Quality of Life
SF-36 Health questionnaire scores range from 0 to 100% and indicate the self-perceived health-related quality of life

Full Information

First Posted
March 24, 2013
Last Updated
March 23, 2015
Sponsor
Universidad de Almeria
Collaborators
Universidad de Granada
search

1. Study Identification

Unique Protocol Identification Number
NCT01822236
Brief Title
Craniosacral Therapy to Treat Chronic Low Back Pain
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 Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
April 2013 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad de Almeria
Collaborators
Universidad de Granada

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain
Keywords
low back pain, Manual Therapy, Randomized Controlled Trial, Quality of life

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Craniosacral Therapy Program
Arm Type
Experimental
Arm Description
A program of 10 craniosacral therapy techniques
Arm Title
One technique of craniosacral therapy
Arm Type
Active Comparator
Arm Description
Decompression L5-S1.
Intervention Type
Other
Intervention Name(s)
Craniosacral Therapy Program
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
One technique of craniosacral therapy
Intervention Description
Decompression L5-S1: lumbosacral decompression
Primary Outcome Measure Information:
Title
Change for the Roland Morris Disability Questionnaire
Description
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
Time Frame
At baseline, 10 weeks and 15 weeks
Secondary Outcome Measure Information:
Title
Change for the Lifestyle indicators
Description
Estimation interstitial fluid biochemistry and measure the following indicators: body mass, hormonal, autonomic nervous system and oxidative stress.
Time Frame
At baseline, 10 weeks and 15 weeks
Title
Change on Neural Network Analysis
Description
Analysis of the projection on the spine and segmental innervation projection
Time Frame
At baseline, 10 weeks and 15 weeks
Title
Change on Quality of Life
Description
SF-36 Health questionnaire scores range from 0 to 100% and indicate the self-perceived health-related quality of life
Time Frame
At baseline, 10 weeks and 15 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adelaida Castro-Sánchez, PhD
Organizational Affiliation
Universidad de Almeria
Official's Role
Study Director
Facility Information:
Facility Name
Universidad de Almeria
City
Almeria
ZIP/Postal Code
04120
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
23337558
Citation
Arnadottir TS, Sigurdardottir AK. Is craniosacral therapy effective for migraine? Tested with HIT-6 Questionnaire. Complement Ther Clin Pract. 2013 Feb;19(1):11-4. doi: 10.1016/j.ctcp.2012.09.003. Epub 2012 Nov 9.
Results Reference
background
PubMed Identifier
23131379
Citation
Jakel A, von Hauenschild P. A systematic review to evaluate the clinical benefits of craniosacral therapy. Complement Ther Med. 2012 Dec;20(6):456-65. doi: 10.1016/j.ctim.2012.07.009. Epub 2012 Aug 22.
Results Reference
background
PubMed Identifier
21732734
Citation
Curtis P, Gaylord SA, Park J, Faurot KR, Coble R, Suchindran C, Coeytaux RR, Wilkinson L, Mann JD. Credibility of low-strength static magnet therapy as an attention control intervention for a randomized controlled study of CranioSacral therapy for migraine headaches. J Altern Complement Med. 2011 Aug;17(8):711-21. doi: 10.1089/acm.2010.0277. Epub 2011 Jul 6.
Results Reference
background
PubMed Identifier
21214395
Citation
Harrison RE, Page JS. Multipractitioner Upledger CranioSacral Therapy: descriptive outcome study 2007-2008. J Altern Complement Med. 2011 Jan;17(1):13-7. doi: 10.1089/acm.2009.0644. Epub 2011 Jan 9.
Results Reference
background
PubMed Identifier
20702514
Citation
Castro-Sanchez AM, Mataran-Penarrocha GA, Sanchez-Labraca N, Quesada-Rubio JM, Granero-Molina J, Moreno-Lorenzo C. A randomized controlled trial investigating the effects of craniosacral therapy on pain and heart rate variability in fibromyalgia patients. Clin Rehabil. 2011 Jan;25(1):25-35. doi: 10.1177/0269215510375909. Epub 2010 Aug 11.
Results Reference
background
PubMed Identifier
23369067
Citation
Elden H, Ostgaard HC, Glantz A, Marciniak P, Linner AC, Olsen MF. Effects of craniosacral therapy as adjunct to standard treatment for pelvic girdle pain in pregnant women: a multicenter, single blind, randomized controlled trial. Acta Obstet Gynecol Scand. 2013 Jul;92(7):775-82. doi: 10.1111/aogs.12096. Epub 2013 Mar 4.
Results Reference
background
PubMed Identifier
19733816
Citation
Gillespie BR. Case study in attention-deficit/hyperactivity disorder: the corrective aspect of craniosacral fascial therapy. Explore (NY). 2009 Sep-Oct;5(5):296-8. doi: 10.1016/j.explore.2009.06.003. No abstract available.
Results Reference
background
PubMed Identifier
19729492
Citation
Mataran-Penarrocha GA, Castro-Sanchez AM, Garcia GC, Moreno-Lorenzo C, Carreno TP, Zafra MD. Influence of craniosacral therapy on anxiety, depression and quality of life in patients with fibromyalgia. Evid Based Complement Alternat Med. 2011;2011:178769. doi: 10.1093/ecam/nep125. Epub 2011 Jun 15.
Results Reference
background
PubMed Identifier
19469218
Citation
Holla M, Ijland MM, van der Vliet AM, Edwards M, Verlaat CW. [Death of an infant following 'craniosacral' manipulation of the neck and spine]. Ned Tijdschr Geneeskd. 2009 Apr 25;153(17):828-31. Dutch.
Results Reference
background
PubMed Identifier
18541041
Citation
Mann JD, Faurot KR, Wilkinson L, Curtis P, Coeytaux RR, Suchindran C, Gaylord SA. Craniosacral therapy for migraine: protocol development for an exploratory controlled clinical trial. BMC Complement Altern Med. 2008 Jun 9;8:28. doi: 10.1186/1472-6882-8-28.
Results Reference
background
PubMed Identifier
18350746
Citation
Gerdner LA, Hart LK, Zimmerman MB. Craniosacral still point technique: exploring its effects in individuals with dementia. J Gerontol Nurs. 2008 Mar;34(3):36-45. doi: 10.3928/00989134-20080301-04.
Results Reference
background
PubMed Identifier
18047438
Citation
McManus V, Gliksten M. The use of CranioSacral therapy in a physically impaired population in a disability service in southern Ireland. J Altern Complement Med. 2007 Nov;13(9):929-30. doi: 10.1089/acm.2007.0521. No abstract available.
Results Reference
background
PubMed Identifier
17154138
Citation
Downey PA, Barbano T, Kapur-Wadhwa R, Sciote JJ, Siegel MI, Mooney MP. Craniosacral therapy: the effects of cranial manipulation on intracranial pressure and cranial bone movement. J Orthop Sports Phys Ther. 2006 Nov;36(11):845-53. doi: 10.2519/jospt.2006.36.11.845.
Results Reference
background
PubMed Identifier
17154136
Citation
Flynn TW, Cleland JA, Schaible P. Craniosacral therapy and professional responsibility. J Orthop Sports Phys Ther. 2006 Nov;36(11):834-6. doi: 10.2519/jospt.2006.0112. No abstract available.
Results Reference
background
PubMed Identifier
16221407
Citation
Bergkvist H. [A reflection over craniosacral therapy]. Ugeskr Laeger. 2005 Oct 3;167(40):3801-2. No abstract available. Danish.
Results Reference
background
PubMed Identifier
15062718
Citation
Maher CG. Effective physical treatment for chronic low back pain. Orthop Clin North Am. 2004 Jan;35(1):57-64. doi: 10.1016/S0030-5898(03)00088-9.
Results Reference
background
PubMed Identifier
11313614
Citation
Moran RW, Gibbons P. Intraexaminer and interexaminer reliability for palpation of the cranial rhythmic impulse at the head and sacrum. J Manipulative Physiol Ther. 2001 Mar-Apr;24(3):183-90.
Results Reference
background
PubMed Identifier
10709302
Citation
Green C, Martin CW, Bassett K, Kazanjian A. A systematic review of craniosacral therapy: biological plausibility, assessment reliability and clinical effectiveness. Complement Ther Med. 1999 Dec;7(4):201-7. doi: 10.1016/s0965-2299(99)80002-8.
Results Reference
background
PubMed Identifier
7899490
Citation
Upledger JE. Craniosacral therapy. Phys Ther. 1995 Apr;75(4):328-30. doi: 10.1093/ptj/75.4.328. No abstract available.
Results Reference
background

Learn more about this trial

Craniosacral Therapy to Treat Chronic Low Back Pain

We'll reach out to this number within 24 hrs