- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01500330
Home Use of Cupping Massage in Chronic Neck Pain (NaSK)
October 8, 2013 updated by: Romy Lauche, Universität Duisburg-Essen
Randomised Controlled Study on the Effectiveness of Cupping Massage for Home Use in Chronic Neck Pain [Randomisierte Kontrollierte Studie Zur Wirksamkeit Der Schröpfkopfmassage Als Heimanwendung Bei Chronischen Nackenschmerzen]
The purpose of this randomized controlled study is to determine the effectiveness of cupping massage as home use for patients with chronic nonspecific neck pain compared to relaxation exercise.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
see above
Study Type
Interventional
Enrollment (Actual)
84
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Essen, Germany
- Klinik für Naturheilkunde
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- mean neck pain intensity 45mm
- neck pain for at least 3 months
- age 18-75
- partner or friend for the application of the massage
Exclusion Criteria:
- specific neck pain due to trauma, neurological disorder, prolapse, operation, cancer
- severe deformity of the spine
- skin disease, allergy on the neck area
- hemophilia, anticoagulation, antiplatelet disorder
- severe psychiatric disorder
- severe comorbidity
- regular intake of opiates and corticosteroids >10mg prednisolon
- pregnancy
- participation in other clinical trials
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: cupping massage
12 weeks home use of cupping massage (delivered by the partner or friend) twice a week for 20 minutes
|
the upper back is covered in massage oil the cupping glass is drawn along the back muscles
|
Active Comparator: control group
progressive muscle relaxation twice a week for 20 minutes
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standardized programme on muscle relaxation according to Jacobson
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain Intensity
Time Frame: T2 (84 days)
|
Pain intensity on a 100mm visual analogue scale
|
T2 (84 days)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain diary
Time Frame: week 12
|
Pain intensity on a visual analogue scale
|
week 12
|
pain intensity in motion
Time Frame: T2 (84 days)
|
Pain intensity induced by flexion, extension, lateral flexion and rotation of the head
|
T2 (84 days)
|
pain quality
Time Frame: T2 (84 days)
|
sensory and affective pain quality, questionnaire
|
T2 (84 days)
|
well being
Time Frame: T2 (84 days)
|
Well being measured by questionnaire (FEW16)
|
T2 (84 days)
|
Quality of life
Time Frame: T2 (84 days)
|
measured by the SF-36
|
T2 (84 days)
|
Stress perception
Time Frame: T2 (84 days)
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Measured by the PSQ20
|
T2 (84 days)
|
Control belief
Time Frame: T2 (84 days)
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measured by the GKÜ (questionnaire on control beliefs)
|
T2 (84 days)
|
Pressure pain threshold
Time Frame: T2 (84 days)
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pressure pain threshold measured with an algometer on predefined muscles and the pain maximum
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T2 (84 days)
|
Safety
Time Frame: T2(84 days)
|
all adverse events are recorded
|
T2(84 days)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Thomas Rampp, MD, Chair of Complementary and Integrative Medicine, University Duisburg-Essen, Germany
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2012
Primary Completion (Actual)
May 1, 2012
Study Completion (Actual)
May 1, 2012
Study Registration Dates
First Submitted
December 22, 2011
First Submitted That Met QC Criteria
December 22, 2011
First Posted (Estimate)
December 28, 2011
Study Record Updates
Last Update Posted (Estimate)
October 9, 2013
Last Update Submitted That Met QC Criteria
October 8, 2013
Last Verified
October 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NaSK
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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