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

Randomised Controlled Pilot Study: the Effect of Dry Cupping on Pain and Sensory Thresholds in the Treatment of Chronic Non Specific Neck Pain

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.

Study Overview

• Status: Completed
• Conditions: Neck Pain; Neck Pain Musculoskeletal; Mechanical/Motor Problems With Neck and Trunk
• Intervention / Treatment: Procedure: Dry Cupping or fire cupping

Detailed Description

see above

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • NRW
    • Essen, NRW, Germany, 45276
      • Knappschaftskrankenhaus

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: Cupping is: heating glas cups to create a vacuum on the skin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain intensity	100mm Visual Analogue Scale	at T2 (Day 25)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
pain related to movement	100mm Visual Analogue Scale for 6 movement directions (Irnich, BMJ 2001)	at T2 (Day 25)
pain diary	Daily rating of pain intensity (numeric rating scale from 0-10)	from T0 (Day 0) to T2 (Day25)
Neck disability index	NDI measures neck pain complaints (Vernon und Mior 1991)	at T2 (Day 25)
Quality of Life SF-36	the sf-36 is a short form health survey consisting of 8 scales to measure functional health and wellbeing (Bullinger & Kirchberger 1998)	at T2 (Day 25)
mechanical detection threshold MDT	by von Frey filaments to measure perception threshold for light touch (Rolke, Pain, 2006)	at T2 (Day 25)
vibration detection threshold VDT	with a tuning fork to measure perception threshold for vibration (Rolke, Pain, 2006)	at T2 (Day 25)
pressure pain threshold PPT	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	at T2 (Day 25)
Side effects	open question on any side effects or other experiences with the treatment	from T1 (Day 7) to T2 (Day 25)
Medication diary	patient report used medication during the study period (amount, dose)	From T0 (Day 0) to T2 (Day 25)

Collaborators and Investigators

• Sponsor: Universität Duisburg-Essen
• Investigators: Principal Investigator: Gustav J Dobos, Prof. MD, University of Duisburg-Essen, Chair of Complementary and Integrative Medicine

Publications and helpful links

General Publications

• Lauche R, Cramer H, Choi KE, Rampp T, Saha FJ, Dobos GJ, Musial F. The influence of a series of five dry cupping treatments on pain and mechanical thresholds in patients with chronic non-specific neck pain--a randomised controlled pilot study. BMC Complement Altern Med. 2011 Aug 15;11:63. doi: 10.1186/1472-6882-11-63.

Study record dates

Study Major Dates

• Study Start: July 1, 2009
• Primary Completion (Actual): December 1, 2009
• Study Completion (Actual): December 1, 2009

Study Registration Dates

• First Submitted: January 31, 2011
• First Submitted That Met QC Criteria: February 3, 2011
• First Posted (Estimate): February 4, 2011

Study Record Updates

• Last Update Posted (Estimate): August 19, 2011
• Last Update Submitted That Met QC Criteria: August 18, 2011
• Last Verified: July 1, 2009

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Neck Pain
• Other Study ID Numbers: DryCupping2009