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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01500330
Other study ID # NaSK
Secondary ID
Status Completed
Phase N/A
First received December 22, 2011
Last updated October 8, 2013
Start date January 2012
Est. completion date May 2012

Study information

Verified date October 2013
Source Universität Duisburg-Essen
Contact n/a
Is FDA regulated No
Health authority Germany: Ethics Commission
Study type Interventional

Clinical Trial 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.


Description:

see above


Recruitment information / eligibility

Status Completed
Enrollment 84
Est. completion date May 2012
Est. primary completion date May 2012
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 75 Years
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Procedure:
cupping massage
the upper back is covered in massage oil the cupping glass is drawn along the back muscles
Progressive muscle relaxation
standardized programme on muscle relaxation according to Jacobson

Locations

Country Name City State
Germany Klinik für Naturheilkunde Essen

Sponsors (1)

Lead Sponsor Collaborator
Universität Duisburg-Essen

Country where clinical trial is conducted

Germany, 

References & Publications (1)

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 — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Pain Intensity Pain intensity on a 100mm visual analogue scale T2 (84 days) No
Secondary Pain diary Pain intensity on a visual analogue scale week 12 No
Secondary pain intensity in motion Pain intensity induced by flexion, extension, lateral flexion and rotation of the head T2 (84 days) No
Secondary pain quality sensory and affective pain quality, questionnaire T2 (84 days) No
Secondary well being Well being measured by questionnaire (FEW16) T2 (84 days) No
Secondary Quality of life measured by the SF-36 T2 (84 days) No
Secondary Stress perception Measured by the PSQ20 T2 (84 days) No
Secondary Control belief measured by the GKÜ (questionnaire on control beliefs) T2 (84 days) No
Secondary Pressure pain threshold pressure pain threshold measured with an algometer on predefined muscles and the pain maximum T2 (84 days) No
Secondary Safety all adverse events are recorded T2(84 days) No
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