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Home Use of Cupping Massage in Chronic Neck Pain (NaSK)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Romy Lauche, Universität Duisburg-Essen
ClinicalTrials.gov Identifier:
NCT01500330
First received: December 22, 2011
Last updated: October 8, 2013
Last verified: October 2013
History of Changes
  Purpose

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.


Condition Intervention
Neck Pain
 Procedure: cupping massage
Procedure: Progressive muscle relaxation

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Universität Duisburg-Essen:

Primary Outcome Measures:
  • Pain Intensity [ Time Frame: T2 (84 days) ] [ Designated as safety issue: No ]
    Pain intensity on a 100mm visual analogue scale


Secondary Outcome Measures:
  • Pain diary [ Time Frame: week 12 ] [ Designated as safety issue: No ]
    Pain intensity on a visual analogue scale

  • pain intensity in motion [ Time Frame: T2 (84 days) ] [ Designated as safety issue: No ]
    Pain intensity induced by flexion, extension, lateral flexion and rotation of the head

  • pain quality [ Time Frame: T2 (84 days) ] [ Designated as safety issue: No ]
    sensory and affective pain quality, questionnaire

  • well being [ Time Frame: T2 (84 days) ] [ Designated as safety issue: No ]
    Well being measured by questionnaire (FEW16)

  • Quality of life [ Time Frame: T2 (84 days) ] [ Designated as safety issue: No ]
    measured by the SF-36

  • Stress perception [ Time Frame: T2 (84 days) ] [ Designated as safety issue: No ]
    Measured by the PSQ20

  • Control belief [ Time Frame: T2 (84 days) ] [ Designated as safety issue: No ]
    measured by the GKÜ (questionnaire on control beliefs)

  • Pressure pain threshold [ Time Frame: T2 (84 days) ] [ Designated as safety issue: No ]
    pressure pain threshold measured with an algometer on predefined muscles and the pain maximum

  • Safety [ Time Frame: T2(84 days) ] [ Designated as safety issue: No ]
    all adverse events are recorded
Enrollment: 84
Study Start Date: January 2012
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: cupping massage
12 weeks home use of cupping massage (delivered by the partner or friend) twice a week for 20 minutes
 Procedure: cupping massage
the upper back is covered in massage oil the cupping glass is drawn along the back muscles
Other Name: cupping massage
Active Comparator: control group
progressive muscle relaxation twice a week for 20 minutes
 Procedure: Progressive muscle relaxation
standardized programme on muscle relaxation according to Jacobson
Other Name: Progressive muscle relaxation

Detailed Description:

see above

  Eligibility
Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01500330

Locations
Germany
Klinik für Naturheilkunde
Essen, Germany
Sponsors and Collaborators
Universität Duisburg-Essen
Investigators
Principal Investigator: Thomas Rampp, MD Chair of Complementary and Integrative Medicine, University Duisburg-Essen, Germany
  More Information

Additional Information:
Homepage "Klinik für Naturheilkunde"  This link exits the ClinicalTrials.gov site

Publications:

Responsible Party: Romy Lauche, Study coordinator, Universität Duisburg-Essen
ClinicalTrials.gov Identifier: NCT01500330     History of Changes
Other Study ID Numbers: NaSK
Study First Received: December 22, 2011
Last Updated: October 8, 2013
Health Authority: Germany: Ethics Commission

Additional relevant MeSH terms:
Neck Pain
Nervous System Diseases
Neurologic Manifestations
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on March 03, 2015