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Effects of Craniosacral Therapy on Chronic Neck Pain (CranioS)

Primary Purpose

Neck Pain

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Craniosacral Therapy
Sham Craniosacral Therapy
Sponsored by
Universität Duisburg-Essen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neck Pain focused on measuring Neck Pain, Craniosacral Manipulation, Complementary Therapies, Randomized Controlled Trial, Sensory Thresholds, Quality of Life

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Kliniken Essen-Mitte

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Craniosacral Therapy (CST)

Sham Craniosacral Therapy (SHAM)

Arm Description

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

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

Outcomes

Primary Outcome Measures

Pain intensity
Pain intensity on a 100mm visual analogue scale (VAS)

Secondary Outcome Measures

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

Full Information

First Posted
February 1, 2012
Last Updated
February 20, 2019
Sponsor
Universität Duisburg-Essen
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1. Study Identification

Unique Protocol Identification Number
NCT01526447
Brief Title
Effects of Craniosacral Therapy on Chronic Neck Pain
Acronym
CranioS
Official Title
Effects of Craniosacral Therapy on Chronic Neck Pain: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
February 2012 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
April 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universität Duisburg-Essen

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neck Pain
Keywords
Neck Pain, Craniosacral Manipulation, Complementary Therapies, Randomized Controlled Trial, Sensory Thresholds, Quality of Life

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
54 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Craniosacral Therapy (CST)
Arm Type
Experimental
Arm Description
Each participant of the experimental group receives 8 Craniosacral Therapy units once a week of 45 minutes.
Arm Title
Sham Craniosacral Therapy (SHAM)
Arm Type
Sham Comparator
Arm Description
Each participant of the sham group receives 8 sham therapy units once a week of 45 minutes.
Intervention Type
Procedure
Intervention Name(s)
Craniosacral Therapy
Intervention Description
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
Intervention Name(s)
Sham Craniosacral Therapy
Intervention Description
Standardized sham protocol: Placing hands on various parts of the clothed body for two minutes each time without therapeutic intention
Primary Outcome Measure Information:
Title
Pain intensity
Description
Pain intensity on a 100mm visual analogue scale (VAS)
Time Frame
week 8
Secondary Outcome Measure Information:
Title
Pain intensity in motion
Description
Pain intensity induced by flexion, extension, lateral flexion and rotation of the head on a 100mm visual analogue scale (VAS)
Time Frame
week 8
Title
Pressure pain threshold
Description
Pressure pain threshold (PPT) measured with an algometer on predefined muscles and the pain maximum
Time Frame
week 8
Title
Disability
Description
Measured by the Neck Disability Indx (NDI)
Time Frame
week 8
Title
Quality of life
Description
Measured by the Short-Form Health Survey (SF-12)
Time Frame
week 8
Title
Well being
Description
Measured by the Questionnaire for Assessing Subjective Physical Well-Being (FEW-16)
Time Frame
week 8
Title
Anxiety and depression
Description
Measured by the Hospital Anxiety and Depression Scale (HADS)
Time Frame
week 8
Title
Stress perception
Description
Measured by the Perceived Stress Questionnaire (PSQ-20)
Time Frame
week 8
Title
Pain acceptance
Description
Measured by the Emotional and Rational Disease Acceptance Questionnaire (ERDA)
Time Frame
week 8
Title
Body awareness
Description
Measured by the Scale of Body Connection (SBC)
Time Frame
week 8
Title
Global Impression
Description
Measured by the Patient Global Impression of Improvement Questionnaire (PGI-I)
Time Frame
week 8
Title
Safety
Description
All adverse events are recorded
Time Frame
week 8

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gustav Dobos, Prof. MD
Organizational Affiliation
Department of Internal and Integrative Medicine, Kliniken Essen-Mitte, Faculty of Medicine, University Duisburg-Essen, Germany
Official's Role
Study Director
Facility Information:
Facility Name
Kliniken Essen-Mitte
City
Essen
State/Province
NRW
ZIP/Postal Code
45276
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
25453528
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.
Results Reference
background
PubMed Identifier
26340656
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.
Results Reference
result

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Effects of Craniosacral Therapy on Chronic Neck Pain

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