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The Effect of 5 Times Dry Cupping in the Treatment of Chronic Neck Pain (TS)

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ClinicalTrials.gov Identifier: NCT01289964
Recruitment Status : Completed
First Posted : February 4, 2011
Last Update Posted : August 19, 2011
Sponsor:
Information provided by:
Universität Duisburg-Essen

Study Description
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Brief Summary:
The study aims to investigate the influence of 5 dry cupping treatments on chronic non specific neck pain. 50 patients with neck pain are randomised into cupping treatment and waiting list control group at T0 (Day 0). At T1 (Day 7)the investigators evaluate the neck pain (VAS), the neck related disability (NDI), pain related to movement (PRTM) and the quality of life (SF36). To investigate neurophysiological effects of cupping we also measure mechanical detection threshold (MDT), vibration detection threshold (VDT) and pressure pain threshold (PPT) at pain related and control areas. The treatment group then receives 5 cupping treatments over a period of two weeks. After the cupping series resp. a waiting period for the waiting list control group (T2, Day 25) all measurements from T1 are repeated (VAS, NDI, PRTM, SF36, MDT, PPT, VDT). At last, a pain and medication diary is filled in by the patients from T0(Day 0) until T2 (Day 25). The investigators hypothesize, that cupping treatment is effective against neck pain (diary, VAS, NDI, PRTM, SF36) and that it leads to changes on perceptual level (MDT, VDT, PPT), when compared to the waiting list control group.

Condition or disease Intervention/treatment Phase
Neck Pain Neck Pain Musculoskeletal Mechanical/Motor Problems With Neck and Trunk Procedure: Dry Cupping or fire cupping Not Applicable

Detailed Description:
see above
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomised Controlled Pilot Study: the Effect of Dry Cupping on Pain and Sensory Thresholds in the Treatment of Chronic Non Specific Neck Pain
Study Start Date : July 2009
Actual Primary Completion Date : December 2009
Actual Study Completion Date : December 2009

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Arms and Interventions
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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
Active Comparator: Treatment group
Received the 5 cupping treatments, application twice a week, non standardised application - individual determinations of trigger points
 Procedure: Dry Cupping or fire cupping
5 dry cupping treatments, application twice a week, non standardised procedure
Other Name: Cupping is: heating glas cups to create a vacuum on the skin


Outcome Measures
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Primary Outcome Measures :
  1. Pain intensity [ Time Frame: at T2 (Day 25) ]
    100mm Visual Analogue Scale


Secondary Outcome Measures :
  1. pain related to movement [ Time Frame: at T2 (Day 25) ]
    100mm Visual Analogue Scale for 6 movement directions (Irnich, BMJ 2001)

  2. pain diary [ Time Frame: from T0 (Day 0) to T2 (Day25) ]
    Daily rating of pain intensity (numeric rating scale from 0-10)

  3. Neck disability index [ Time Frame: at T2 (Day 25) ]
    NDI measures neck pain complaints (Vernon und Mior 1991)

  4. Quality of Life SF-36 [ Time Frame: at T2 (Day 25) ]
    the sf-36 is a short form health survey consisting of 8 scales to measure functional health and wellbeing (Bullinger & Kirchberger 1998)

  5. mechanical detection threshold MDT [ Time Frame: at T2 (Day 25) ]
    by von Frey filaments to measure perception threshold for light touch (Rolke, Pain, 2006)

  6. vibration detection threshold VDT [ Time Frame: at T2 (Day 25) ]
    with a tuning fork to measure perception threshold for vibration (Rolke, Pain, 2006)

  7. pressure pain threshold PPT [ Time Frame: at T2 (Day 25) ]
    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

  8. Side effects [ Time Frame: from T1 (Day 7) to T2 (Day 25) ]
    open question on any side effects or other experiences with the treatment

  9. Medication diary [ Time Frame: From T0 (Day 0) to T2 (Day 25) ]
    patient report used medication during the study period (amount, dose)


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:

  • 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)
  • having been in treatment to an orthopaedic or to a neurologist

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.
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): NCT01289964


Locations
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Germany
Knappschaftskrankenhaus
Essen, NRW, Germany, 45276
Sponsors and Collaborators
Universität Duisburg-Essen
Investigators
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Principal Investigator: Gustav J Dobos, Prof. MD University of Duisburg-Essen, Chair of Complementary and Integrative Medicine
More Information
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Publications of Results:

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Responsible Party: Gustav Dobos, University of Duisburg-Essen, Chair of Complementary and Integrative Medicine
ClinicalTrials.gov Identifier: NCT01289964    
Other Study ID Numbers: DryCupping2009
First Posted: February 4, 2011    Key Record Dates
Last Update Posted: August 19, 2011
Last Verified: July 2009
Additional relevant MeSH terms:
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Neck Pain
Pain
Neurologic Manifestations