- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02651766
The Effects of Cupping Massage in Patients With Chronic Neck Pain - A Randomized Controlled Trial (SKM)
Randomised Controlled Trial on the Influence of Cupping Massage on Pain Intensity and Sensory Mechanical and Pain Thresholds in Patients With Chronic Non Specific Neck Pain
The study aims to investigate the influence of 5 cupping massage treatments on chronic non specific neck pain. 50 patients with neck pain are randomised into cupping treatment and waiting list control group. Before and after the intervention the investigators evaluate the neck pain (VAS), the neck related disability (NDI), pain on movement (POM) and the quality of life (SF36) and safety. To investigate neurophysiological effects of cupping the investigators also measure mechanical detection threshold (MDT), vibration detection threshold (VDT) and pressure pain threshold (PPT) and the two point discrimination threshold at pain related and control areas.
The treatment group receives 5 cupping treatments over a period of 3 weeks.
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
NRW
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Essen, NRW, Germany, 45276
- Knappschaftskrankenhaus
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- age between 18 and 75
- permanent neck pain for at least three months in a row
- a minimum of 40mm of neck pain on a 100mm visual analogue scale (VAS)
Exclusion Criteria:
- neck pain caused by trauma, inflammatory or malignant disease, by congenital malformation of the spine or if pain was accompanied by radicular symptoms such as radiating pain, paresis, prickling or tingling.
- invasive treatments within the last 4 weeks, surgery to the spine within the last year, corticosteroid or opioid treatment.
- serious acute or chronic organic disease such as diabetes or cancer, mental disorders, pregnancy, and haemorrhagic tendency or anticoagulation treatment.
- non steroidal pain medication and physiotherapy were allowed if the treatment regimen was not altered for four weeks before and continued during the study.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Waiting List control group
No treatment within the study period, were allowed to continue physiotherapy and medication.
Were offered the treatment after finishing the study
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|
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Experimental: Cupping massage treatment
Received the 5 cupping treatments, application twice a week on the upper back and neck
|
Using suction on the skin by means of glass cups, and moving the cups after applying massage oil on the skin
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain intensity
Time Frame: 3 weeks
|
100mm Visual Analogue Scale from 0mm 'no pain' to 100mm 'maximal pain'
|
3 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain on movement (POM)
Time Frame: 3 weeks
|
100mm Visual Analogue Scale from 0mm 'no pain' to 100mm 'maximal pain' Intensity rated for 6 movement directions flexion, tension, and rotation
|
3 weeks
|
|
Neck disability index
Time Frame: 3 weeks
|
NDI measures neck pain complaints (Vernon und Mior 1991)
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3 weeks
|
|
Quality of Life SF-36
Time Frame: 3 weeks
|
the sf-36 is a short form health survey consisting of 8 scales to measure functional health and wellbeing (Bullinger & Kirchberger 1998)
|
3 weeks
|
|
mechanical detection threshold MDT
Time Frame: 3 weeks
|
by von Frey filaments to measure perception threshold for light touch (Rolke, Pain, 2006)
|
3 weeks
|
|
vibration detection threshold VDT
Time Frame: 3 weeks
|
with a tuning fork to measure perception threshold for vibration (Rolke, Pain, 2006)
|
3 weeks
|
|
pressure pain threshold PPT
Time Frame: 3 weeks
|
with a pressure gauge algometer to determine threshold for painful pressure (Rolke, Pain, 2006) on the area of maximal neck pain, the adjacent and hand and foot
|
3 weeks
|
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Adverse events
Time Frame: 3 weeks
|
Number of patients with adverse events
|
3 weeks
|
|
two point discrimination threshold
Time Frame: 3 weeks
|
using a pair of circles, determining the distance necessary between those to perceive them as separate sensations
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3 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: GUstav Dobos, Prof MD, University of Duisburg-Essen, Chair of Complementary and Integrative Medicine
Publications and helpful links
General Publications
- Saha FJ, Schumann S, Cramer H, Hohmann C, Choi KE, Rolke R, Langhorst J, Rampp T, Dobos G, Lauche R. The Effects of Cupping Massage in Patients with Chronic Neck Pain - A Randomised Controlled Trial. Complement Med Res. 2017;24(1):26-32. doi: 10.1159/000454872. Epub 2017 Feb 15.
- Schumann S, Lauche R, Hohmann C, Zirbes T, Dobos G, Saha FJ. [Development of lipoma following a single cupping massage - a case report]. Forsch Komplementmed. 2012;19(4):202-5. doi: 10.1159/000341869. Epub 2012 Aug 20. German.
- Schumann S, Lauche R, Irmisch G, Hohmann C, Rolke R, Saha F, Cramer H, Choi KE, Langhorst J, Rampp T, Dobos G, Musial F. The effects of 5 sessions of cupping massage on chronic non-specific neck pain: A randomized controlled pilot study. BMC Complementary and Alternative Medicine, 2012, 12 (Supplement 1): 80.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 09-3987-BO
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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