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

This study has been completed.
Sponsor:
Information provided by:
Universität Duisburg-Essen
ClinicalTrials.gov Identifier:
NCT01289964
First received: January 31, 2011
Last updated: August 18, 2011
Last verified: July 2009
  Purpose

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 Intervention
Neck Pain
Neck Pain Musculoskeletal
Mechanical/Motor Problems With Neck and Trunk
Procedure: Dry Cupping or fire cupping

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Universität Duisburg-Essen:

Primary Outcome Measures:
  • Pain intensity [ Time Frame: at T2 (Day 25) ] [ Designated as safety issue: No ]
    100mm Visual Analogue Scale


Secondary Outcome Measures:
  • pain related to movement [ Time Frame: at T2 (Day 25) ] [ Designated as safety issue: No ]
    100mm Visual Analogue Scale for 6 movement directions (Irnich, BMJ 2001)

  • pain diary [ Time Frame: from T0 (Day 0) to T2 (Day25) ] [ Designated as safety issue: No ]
    Daily rating of pain intensity (numeric rating scale from 0-10)

  • Neck disability index [ Time Frame: at T2 (Day 25) ] [ Designated as safety issue: No ]
    NDI measures neck pain complaints (Vernon und Mior 1991)

  • Quality of Life SF-36 [ Time Frame: at T2 (Day 25) ] [ Designated as safety issue: No ]
    the sf-36 is a short form health survey consisting of 8 scales to measure functional health and wellbeing (Bullinger & Kirchberger 1998)

  • mechanical detection threshold MDT [ Time Frame: at T2 (Day 25) ] [ Designated as safety issue: No ]
    by von Frey filaments to measure perception threshold for light touch (Rolke, Pain, 2006)

  • vibration detection threshold VDT [ Time Frame: at T2 (Day 25) ] [ Designated as safety issue: No ]
    with a tuning fork to measure perception threshold for vibration (Rolke, Pain, 2006)

  • pressure pain threshold PPT [ Time Frame: at T2 (Day 25) ] [ Designated as safety issue: No ]
    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

  • Side effects [ Time Frame: from T1 (Day 7) to T2 (Day 25) ] [ Designated as safety issue: Yes ]
    open question on any side effects or other experiences with the treatment

  • Medication diary [ Time Frame: From T0 (Day 0) to T2 (Day 25) ] [ Designated as safety issue: No ]
    patient report used medication during the study period (amount, dose)


Enrollment: 50
Study Start Date: July 2009
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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:

  • 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
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: NCT01289964

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

Publications:
Responsible Party: Gustav Dobos, University of Duisburg-Essen, Chair of Complementary and Integrative Medicine
ClinicalTrials.gov Identifier: NCT01289964     History of Changes
Other Study ID Numbers: DryCupping2009
Study First Received: January 31, 2011
Last Updated: August 18, 2011
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 November 25, 2014