Effects of Craniosacral Therapy on Chronic Neck Pain

NCT ID: NCT01526447

Last Updated: 2019-02-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 54 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-02-29
• Study Completion Date: 2013-04-30

Brief 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.

Detailed 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.

Conditions

Neck Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Craniosacral Therapy (CST)

Each participant of the experimental group receives 8 Craniosacral Therapy units once a week of 45 minutes.

Group Type: EXPERIMENTAL

Craniosacral Therapy

Intervention Type: PROCEDURE

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 (SHAM)

Each participant of the sham group receives 8 sham therapy units once a week of 45 minutes.

Group Type: SHAM_COMPARATOR

Sham Craniosacral Therapy

Intervention Type: PROCEDURE

Standardized sham protocol: Placing hands on various parts of the clothed body for two minutes each time without therapeutic intention

Interventions

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

Intervention Type: PROCEDURE

Sham Craniosacral Therapy

Standardized sham protocol: Placing hands on various parts of the clothed body for two minutes each time without therapeutic intention

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universität Duisburg-Essen

OTHER

Sponsor Role: lead

Responsible Party

Heidemarie Haller

Postdoctoral Research Fellow

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gustav Dobos, Prof. MD

Role: STUDY_DIRECTOR

Department of Internal and Integrative Medicine, Kliniken Essen-Mitte, Faculty of Medicine, University Duisburg-Essen, Germany

Locations

Kliniken Essen-Mitte

Essen, North Rhine-Westphalia, Germany

Countries

Germany

References

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.

Reference Type: BACKGROUND

PMID: 25453528 (View on PubMed)

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.

Reference Type: RESULT

PMID: 26340656 (View on PubMed)

Other Identifiers

11-4850

Identifier Type: -

Identifier Source: org_study_id