Craniosacral Therapy to Treat Chronic Low Back Pain

Low Back Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01822236
• Other study ID #: UAL-123
• Status: Completed
• Phase: N/A
• First received: March 24, 2013
• Last updated: March 23, 2015
• Start date: April 2013
• Est. completion date: December 2013

Study information

• Verified date: March 2015
• Source: Universidad de Almeria
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 25 Years to 60 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Intervention

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.
• One technique of craniosacral therapy
Decompression L5-S1: lumbosacral decompression

Locations

Country	Name	City	State
Spain	Universidad de Almeria	Almeria

Sponsors (2)

Lead Sponsor	Collaborator
Universidad de Almeria	Universidad de Granada

Country where clinical trial is conducted

Spain, 

References & Publications (19)

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. — View Citation

Bergkvist H. [A reflection over craniosacral therapy]. Ugeskr Laeger. 2005 Oct 3;167(40):3801-2. Danish. — View Citation

Castro-Sánchez AM, Matarán-Peñarrocha GA, Sánchez-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. — View 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. — View 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. — View Citation

Elden H, Östgaard HC, Glantz A, Marciniak P, Linnér AC, Olsén 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. — View Citation

Flynn TW, Cleland JA, Schaible P. Craniosacral therapy and professional responsibility. J Orthop Sports Phys Ther. 2006 Nov;36(11):834-6. — View 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. — View 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. — View 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. Review. — View 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. — View 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. — View Citation

Jäkel 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. Review. — View Citation

Maher CG. Effective physical treatment for chronic low back pain. Orthop Clin North Am. 2004 Jan;35(1):57-64. Review. — View 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. — View Citation

Matarán-Peñarrocha GA, Castro-Sánchez AM, García GC, Moreno-Lorenzo C, Carreño 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. — View 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. — View 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. — View Citation

Upledger JE. Craniosacral therapy. Phys Ther. 1995 Apr;75(4):328-30. — View Citation

* Note: There are 19 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	At baseline, 10 weeks and 15 weeks	No
Secondary	Change for the Lifestyle indicators	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	No
Secondary	Change on Neural Network Analysis	Analysis of the projection on the spine and segmental innervation projection	At baseline, 10 weeks and 15 weeks	No
Secondary	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	At baseline, 10 weeks and 15 weeks	No