Clinical trial NCT01526447: Effects of Craniosacral Therapy on Chronic Neck Pain
Official title: Effects of Craniosacral Therapy on Chronic Neck Pain: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neck Pain
Keywords: Neck Pain
Craniosacral Manipulation
Complementary Therapies
Randomized Controlled Trial
Sensory Thresholds
Quality of Life
Lead sponsor: Universität Duisburg-Essen
Sponsor class: OTHER
First posted: 2012-02-03
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Pain intensity
timeFrame: week 8
Secondary outcomes:
measure: Pain intensity in motion
timeFrame: week 8
measure: Pressure pain threshold
timeFrame: week 8
measure: Disability
timeFrame: week 8
measure: Quality of life
timeFrame: week 8
measure: Well being
timeFrame: week 8
measure: Anxiety and depression
timeFrame: week 8
measure: Stress perception
timeFrame: week 8
measure: Pain acceptance
timeFrame: week 8
measure: Body awareness
timeFrame: week 8
measure: Global Impression
timeFrame: week 8
measure: Safety
timeFrame: week 8
Other outcomes:
Locations:
city: Essen
country: Germany
facility: Kliniken Essen-Mitte
state: NRW
Study officials:
affiliation: Department of Internal and Integrative Medicine, Kliniken Essen-Mitte, Faculty of Medicine, University Duisburg-Essen, Germany
name: Gustav Dobos, Prof. MD
role: STUDY_DIRECTOR
References:
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.
citation: 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.