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

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ClinicalTrials.gov Identifier: NCT01500330
Recruitment Status : Completed
First Posted : December 28, 2011
Last Update Posted : October 9, 2013
Sponsor:
Information provided by (Responsible Party):
Romy Lauche, Universität Duisburg-Essen

Study Description
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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.

Condition or disease Intervention/treatment Phase
Neck Pain Procedure: cupping massage Procedure: Progressive muscle relaxation Not Applicable

Detailed Description:
see above

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 84 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (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]
Study Start Date : January 2012
Actual Primary Completion Date : May 2012
Actual Study Completion Date : May 2012

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Arms and Interventions
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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
 Procedure: cupping massage
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
 Procedure: Progressive muscle relaxation
standardized programme on muscle relaxation according to Jacobson


Outcome Measures
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Primary Outcome Measures :
  1. Pain Intensity [ Time Frame: T2 (84 days) ]
    Pain intensity on a 100mm visual analogue scale


Secondary Outcome Measures :
  1. Pain diary [ Time Frame: week 12 ]
    Pain intensity on a visual analogue scale

  2. pain intensity in motion [ Time Frame: T2 (84 days) ]
    Pain intensity induced by flexion, extension, lateral flexion and rotation of the head

  3. pain quality [ Time Frame: T2 (84 days) ]
    sensory and affective pain quality, questionnaire

  4. well being [ Time Frame: T2 (84 days) ]
    Well being measured by questionnaire (FEW16)

  5. Quality of life [ Time Frame: T2 (84 days) ]
    measured by the SF-36

  6. Stress perception [ Time Frame: T2 (84 days) ]
    Measured by the PSQ20

  7. Control belief [ Time Frame: T2 (84 days) ]
    measured by the GKÜ (questionnaire on control beliefs)

  8. Pressure pain threshold [ Time Frame: T2 (84 days) ]
    pressure pain threshold measured with an algometer on predefined muscles and the pain maximum

  9. Safety [ Time Frame: T2(84 days) ]
    all adverse events are recorded


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
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Additional Information:
Homepage "Klinik für Naturheilkunde"  This link exits the ClinicalTrials.gov site

Publications of Results:

Responsible Party: Romy Lauche, Study coordinator, Universität Duisburg-Essen
ClinicalTrials.gov Identifier: NCT01500330     History of Changes
Other Study ID Numbers: NaSK
First Posted: December 28, 2011    Key Record Dates
Last Update Posted: October 9, 2013
Last Verified: October 2013

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