NCT01822236

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable low-back-pain

Timeline
Completed

Started Apr 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 24, 2013

Completed
8 days until next milestone

Study Start

First participant enrolled

April 1, 2013

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 2, 2013

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

March 25, 2015

Status Verified

March 1, 2015

Enrollment Period

8 months

First QC Date

March 24, 2013

Last Update Submit

March 23, 2015

Conditions

Low Back Pain

Keywords

low back painManual TherapyRandomized Controlled TrialQuality of life

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (3)

  • Change for the Lifestyle indicators

    At baseline, 10 weeks and 15 weeks

  • Change on Neural Network Analysis

    At baseline, 10 weeks and 15 weeks

  • Change on Quality of Life

    At baseline, 10 weeks and 15 weeks

Study Arms (2)

Craniosacral Therapy Program

EXPERIMENTAL

A program of 10 craniosacral therapy techniques

Other: Craniosacral Therapy Program

One technique of craniosacral therapy

ACTIVE COMPARATOR

Decompression L5-S1.

Other: One technique of craniosacral therapy

Interventions

Craniosacral Therapy ProgramOTHER

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.

Craniosacral Therapy Program
One technique of craniosacral therapyOTHER

Decompression L5-S1: lumbosacral decompression

One technique of craniosacral therapy

Eligibility Criteria

Age25 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidad de Almeria

Almería, Almeria, 04120, Spain

Location

Related 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.

    PMID: 23337558BACKGROUND

  • 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.

    PMID: 23131379BACKGROUND

  • 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.

    PMID: 21732734BACKGROUND

  • 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.

    PMID: 21214395BACKGROUND

  • 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.

    PMID: 20702514BACKGROUND

  • 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.

    PMID: 23369067BACKGROUND

  • 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.

    PMID: 19733816BACKGROUND

  • 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.

    PMID: 19729492BACKGROUND

  • 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.

    PMID: 19469218BACKGROUND

  • 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.

    PMID: 18541041BACKGROUND

  • 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.

    PMID: 18350746BACKGROUND

  • 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.

    PMID: 18047438BACKGROUND

  • 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.

    PMID: 17154138BACKGROUND

  • 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.

    PMID: 17154136BACKGROUND

  • Bergkvist H. [A reflection over craniosacral therapy]. Ugeskr Laeger. 2005 Oct 3;167(40):3801-2. No abstract available. Danish.

    PMID: 16221407BACKGROUND

  • 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.

    PMID: 15062718BACKGROUND

  • 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.

    PMID: 11313614BACKGROUND

  • 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.

    PMID: 10709302BACKGROUND

  • Upledger JE. Craniosacral therapy. Phys Ther. 1995 Apr;75(4):328-30. doi: 10.1093/ptj/75.4.328. No abstract available.

    PMID: 7899490BACKGROUND

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Adelaida Castro-Sánchez, PhD

    Universidad de Almeria

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD (Lecturer)

Study Record Dates

First Submitted

March 24, 2013

First Posted

April 2, 2013

Study Start

April 1, 2013

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

March 25, 2015

Record last verified: 2015-03

Locations

ES(1)