Low Back PainNCT01822236

Craniosacral Therapy to Treat Chronic Low Back Pain

A study testing Craniosacral Therapy Program and One technique of craniosacral therapy in people with Low Back Pain, run by Universidad de Almeria at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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. Read more about this study

Who is it for?: Ages 25 to 60 years
Conditions the study is for: Low Back Pain
What is being tested?: Craniosacral Therapy Program and One technique of craniosacral therapy
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 70 participants
Where: 1 siteSpain
Study dates: Apr 2013to Dec 2013
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 25 to 60 years
All sexes
No healthy volunteers
Adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Spain1 site

Universidad de Almeria
Almería, Almeria, 04120

Other trials in Spain

About this study

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

Read the 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.

Conditions: Low Back Pain
Being tested: Craniosacral Therapy Program, One technique of craniosacral therapy
Keywords: low back pain, Manual Therapy, Randomized Controlled Trial, Quality of life
Medical subject headings: Low Back Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT01822236
Study group	Role	What they receive
Craniosacral Therapy Program	Experimental	A program of 10 craniosacral therapy techniques Receives: Other: Craniosacral Therapy Program
One technique of craniosacral therapy	Active comparator	Decompression L5-S1. Receives: Other: One technique of craniosacral therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: At baseline, 10 weeks and 15 weeks

Secondary outcomes (3)

Change for the Lifestyle indicators
Estimation interstitial fluid biochemistry and measure the following indicators: body mass, hormonal, autonomic nervous system and oxidative stress.
Measured: At baseline, 10 weeks and 15 weeks
Change on Neural Network Analysis
Analysis of the projection on the spine and segmental innervation projection
Measured: At baseline, 10 weeks and 15 weeks
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
Measured: At baseline, 10 weeks and 15 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2013Dec 2013

First posted2 Apr 2013 (estimated)
Study startApr 2013
Primary completionDec 2013
Study completionDec 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (19)Papers the sponsor has linked to this study.
Other trials for Low Back PainStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Single group
Masking: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 70 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01822236
Sponsor's protocol ID: UAL-123
Status last verified: Mar 2015
First submitted: 24 Mar 2013
Last updated: 25 Mar 2015
Results posted: No
Data monitoring committee: No

Publications

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.
PubMed 23337558
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.
PubMed 23131379
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.
PubMed 21732734
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.
PubMed 21214395
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.
PubMed 20702514
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.
PubMed 23369067
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.
PubMed 19733816
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.
PubMed 19729492
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.
PubMed 19469218
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.
PubMed 18541041
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.
PubMed 18350746
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.
PubMed 18047438
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.
PubMed 17154138
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.
PubMed 17154136
Bergkvist H. [A reflection over craniosacral therapy]. Ugeskr Laeger. 2005 Oct 3;167(40):3801-2. No abstract available. Danish.
PubMed 16221407

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Low Back Pain trials

Study at a glance

From the registry record, last updated by the sponsor on 25 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT01822236
Acronym / sponsor ID: UAL-123
Conditions: Low Back Pain
Keywords: low back pain, Manual Therapy, Randomized Controlled Trial, Quality of life
Study type: Interventional
Recruitment status: Completed
Enrolment: 70 participants (actual)
Lead sponsor: Universidad de AlmeriaUniversity, hospital or other
Collaborators: Universidad de Granada
Study start: Apr 2013
Primary completion: Dec 2013 (actual)
Study completion: Dec 2013 (actual)
First posted: 2 Apr 2013 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Participants: Seventy patients with chronic non-specific low back pain will be randomly assigned to an experimental and control group.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Single group
Masking: Double blind (participant, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Craniosacral Therapy Program	Experimental	Other: Craniosacral Therapy ProgramA program of 10 craniosacral therapy techniques
One technique of craniosacral therapy	Active comparator	Other: One technique of craniosacral therapyDecompression L5-S1.

Who may qualify

Ages: 25 to 60 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (7 listed)

Clinical signs of radiculopathy
Presence of lumbar stenosis
Fibromyalgia
Spondylolisthesis
History of spinal surgery

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Craniosacral Therapy ProgramThe 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.	Other	Craniosacral Therapy Program
One technique of craniosacral therapyDecompression L5-S1: lumbosacral decompression	Other	One technique of craniosacral therapy

Primary outcome

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

3 secondary outcomes

Change for the Lifestyle indicators
Time frame: At baseline, 10 weeks and 15 weeks
Change on Neural Network Analysis
Time frame: At baseline, 10 weeks and 15 weeks
Change on Quality of Life
Time frame: At baseline, 10 weeks and 15 weeks

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2015.
Background: PubMed 23337558Arnadottir 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.
Background: PubMed 23131379Jakel 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.
Background: PubMed 21732734Curtis 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.
Background: PubMed 21214395Harrison 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.
Background: PubMed 20702514Castro-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.
Background: PubMed 23369067Elden 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.
Background: PubMed 19733816Gillespie 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.
Background: PubMed 19729492Mataran-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.
Background: PubMed 19469218Holla 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.
Background: PubMed 18541041Mann 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.
Background: PubMed 18350746Gerdner 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.
Background: PubMed 18047438McManus 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Adelaida Castro-Sánchez, PhD study director

Universidad de Almeria

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Craniosacral Therapy Program and One technique of craniosacral therapy in people with Low Back Pain, run by Universidad de Almeria at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change for the Roland Morris Disability Questionnaire (time frame: At baseline, 10 weeks and 15 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01822236, which also lists 19 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2015.