Effects of Craniosacral Therapy on Chronic Neck Pain

Neck Pain Clinical Trial

— CranioS  

Official title:

Effects of Craniosacral Therapy on Chronic Neck Pain: A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01526447
• Other study ID #: 11-4850
• Status: Completed
• Phase: N/A
• Start date: February 2012
• Est. completion date: April 2013

Study information

• Verified date: February 2019
• Source: Universität Duisburg-Essen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this randomized controlled trial is to determinate the efficacy and safety of Craniosacral Therapy in the treatment of chronic unspecific neck pain.

Description:

Craniosacral Therapy (CST) is a variation of osteopathic manipulation with an integrative approach. By soft manual palpation of the craniosacral and fascia system sensory, motor, cognitive, and emotional processes can be influenced. In the prevention and treatment of chronic pain syndromes Craniosacral Therapy is demonstrated to be effective in clinical practice and quite a few scientific trials. But yet there are no randomized controlled studies concerning to chronic neck pain. So the aim of this study is to investigate whether a total of 8 CST units of 45 minutes will be effective in patients suffering from chronic nonspecific neck pain in contrast to sham therapy of the same extent. The prospective study design includes measurement points at baseline, post treatment, and 3 months follow-up.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: April 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Chronic unspecific neck pain for at least 3 months

• Mean neck pain of moderate intensity (>/=45mm on VAS)

• Therapy-naive subjects

Exclusion Criteria:

• Specific neck pain due to severe deformity of the spine, prolapse, rheumatic or neurological disorder, trauma, operation or cancer

• other severe somatic or psychiatric comorbidity

• pregnancy

• regular intake of opiates, corticosteroids (>10mg prednisolon), muscle relaxants or antidepressants

• recent invasive or manipulative treatment of the spine

• participation in other clinical trials

Related Conditions & MeSH terms

• Neck Pain

Intervention

Procedure:
• Craniosacral Therapy
Standardized therapy protocol (according to Upledger): Still point technique, diaphragm release, compression-decompression and lift techniques of the cranial bones, facial balancing in the region of shoulder and pelvis and somato-emotional unwinding
• Sham Craniosacral Therapy
Standardized sham protocol: Placing hands on various parts of the clothed body for two minutes each time without therapeutic intention

Locations

Country	Name	City	State
Germany	Kliniken Essen-Mitte	Essen	NRW

Sponsors (1)

Lead Sponsor	Collaborator
Universität Duisburg-Essen

Country where clinical trial is conducted

Germany, 

References & Publications (2)

Haller H, Lauche R, Cramer H, Rampp T, Saha FJ, Ostermann T, Dobos G. Craniosacral Therapy for the Treatment of Chronic Neck Pain: A Randomized Sham-controlled Trial. Clin J Pain. 2016 May;32(5):441-9. doi: 10.1097/AJP.0000000000000290. — View Citation

Haller H, Ostermann T, Lauche R, Cramer H, Dobos G. Credibility of a comparative sham control intervention for Craniosacral Therapy in patients with chronic neck pain. Complement Ther Med. 2014 Dec;22(6):1053-9. doi: 10.1016/j.ctim.2014.09.007. Epub 2014 Oct 6. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain intensity	Pain intensity on a 100mm visual analogue scale (VAS)	week 8
Secondary	Pain intensity in motion	Pain intensity induced by flexion, extension, lateral flexion and rotation of the head on a 100mm visual analogue scale (VAS)	week 8
Secondary	Pressure pain threshold	Pressure pain threshold (PPT) measured with an algometer on predefined muscles and the pain maximum	week 8
Secondary	Disability	Measured by the Neck Disability Indx (NDI)	week 8
Secondary	Quality of life	Measured by the Short-Form Health Survey (SF-12)	week 8
Secondary	Well being	Measured by the Questionnaire for Assessing Subjective Physical Well-Being (FEW-16)	week 8
Secondary	Anxiety and depression	Measured by the Hospital Anxiety and Depression Scale (HADS)	week 8
Secondary	Stress perception	Measured by the Perceived Stress Questionnaire (PSQ-20)	week 8
Secondary	Pain acceptance	Measured by the Emotional and Rational Disease Acceptance Questionnaire (ERDA)	week 8
Secondary	Body awareness	Measured by the Scale of Body Connection (SBC)	week 8
Secondary	Global Impression	Measured by the Patient Global Impression of Improvement Questionnaire (PGI-I)	week 8
Secondary	Safety	All adverse events are recorded	week 8