Back to resultsHome Use of Cupping Massage in Chronic Neck Pain (NaSK)
Primary Purpose
Neck Pain
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
cupping massage
Progressive muscle relaxation
Sponsored by
About this trial
This is an interventional treatment trial for Neck Pain
Eligibility Criteria
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
Sites / Locations
- Klinik für Naturheilkunde
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
cupping massage
control group
Arm Description
12 weeks home use of cupping massage (delivered by the partner or friend) twice a week for 20 minutes
progressive muscle relaxation twice a week for 20 minutes
Outcomes
Primary Outcome Measures
Pain Intensity
Pain intensity on a 100mm visual analogue scale
Secondary Outcome Measures
Pain diary
Pain intensity on a visual analogue scale
pain intensity in motion
Pain intensity induced by flexion, extension, lateral flexion and rotation of the head
pain quality
sensory and affective pain quality, questionnaire
well being
Well being measured by questionnaire (FEW16)
Quality of life
measured by the SF-36
Stress perception
Measured by the PSQ20
Control belief
measured by the GKÜ (questionnaire on control beliefs)
Pressure pain threshold
pressure pain threshold measured with an algometer on predefined muscles and the pain maximum
Safety
all adverse events are recorded
Full Information
NCT ID
NCT01500330
First Posted
December 22, 2011
Last Updated
October 8, 2013
Sponsor
Universität Duisburg-Essen
1. Study Identification
Unique Protocol Identification Number
NCT01500330
Brief Title
Home Use of Cupping Massage in Chronic Neck Pain
Acronym
NaSK
Official Title
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]
Study Type
Interventional
2. Study Status
Record Verification Date
October 2013
Overall Recruitment Status
Completed
Study Start Date
January 2012 (undefined)
Primary Completion Date
May 2012 (Actual)
Study Completion Date
May 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universität Duisburg-Essen
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
Detailed Description
see above
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neck Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
84 (Actual)
8. Arms, Groups, and Interventions
Arm Title
cupping massage
Arm Type
Experimental
Arm Description
12 weeks home use of cupping massage (delivered by the partner or friend) twice a week for 20 minutes
Arm Title
control group
Arm Type
Active Comparator
Arm Description
progressive muscle relaxation twice a week for 20 minutes
Intervention Type
Procedure
Intervention Name(s)
cupping massage
Intervention Description
the upper back is covered in massage oil the cupping glass is drawn along the back muscles
Intervention Type
Procedure
Intervention Name(s)
Progressive muscle relaxation
Intervention Description
standardized programme on muscle relaxation according to Jacobson
Primary Outcome Measure Information:
Title
Pain Intensity
Description
Pain intensity on a 100mm visual analogue scale
Time Frame
T2 (84 days)
Secondary Outcome Measure Information:
Title
Pain diary
Description
Pain intensity on a visual analogue scale
Time Frame
week 12
Title
pain intensity in motion
Description
Pain intensity induced by flexion, extension, lateral flexion and rotation of the head
Time Frame
T2 (84 days)
Title
pain quality
Description
sensory and affective pain quality, questionnaire
Time Frame
T2 (84 days)
Title
well being
Description
Well being measured by questionnaire (FEW16)
Time Frame
T2 (84 days)
Title
Quality of life
Description
measured by the SF-36
Time Frame
T2 (84 days)
Title
Stress perception
Description
Measured by the PSQ20
Time Frame
T2 (84 days)
Title
Control belief
Description
measured by the GKÜ (questionnaire on control beliefs)
Time Frame
T2 (84 days)
Title
Pressure pain threshold
Description
pressure pain threshold measured with an algometer on predefined muscles and the pain maximum
Time Frame
T2 (84 days)
Title
Safety
Description
all adverse events are recorded
Time Frame
T2(84 days)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Rampp, MD
Organizational Affiliation
Chair of Complementary and Integrative Medicine, University Duisburg-Essen, Germany
Official's Role
Principal Investigator
Facility Information:
Facility Name
Klinik für Naturheilkunde
City
Essen
Country
Germany
12. IPD Sharing Statement
Citations:
PubMed Identifier
23762355
Citation
Lauche R, Materdey S, Cramer H, Haller H, Stange R, Dobos G, Rampp T. Effectiveness of home-based cupping massage compared to progressive muscle relaxation in patients with chronic neck pain--a randomized controlled trial. PLoS One. 2013 Jun 7;8(6):e65378. doi: 10.1371/journal.pone.0065378. Print 2013.
Results Reference
result
Links:
URL
http://www.kliniken-essen-mitte.de/leistung/fachabteilungen/naturheilkunde-u-integrative-medizin/home.html
Description
Homepage "Klinik für Naturheilkunde"
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Home Use of Cupping Massage in Chronic Neck Pain
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