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

Neck Pain Clinical Trial

— TS  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01289964
• Other study ID #: DryCupping2009
• Status: Completed
• Phase: N/A
• First received: January 31, 2011
• Last updated: August 18, 2011
• Start date: July 2009
• Est. completion date: December 2009

Study information

• Verified date: July 2009
• Source: Universität Duisburg-Essen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

Description:

see above

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Mechanical/Motor Problems With Neck and Trunk
• Neck Pain
• Neck Pain Musculoskeletal

Intervention

Procedure:
• Dry Cupping or fire cupping
5 dry cupping treatments, application twice a week, non standardised procedure

Locations

Country	Name	City	State
Germany	Knappschaftskrankenhaus	Essen	NRW

Sponsors (1)

Lead Sponsor	Collaborator
Universität Duisburg-Essen

Country where clinical trial is conducted

Germany, 

References & Publications (1)

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 Complem — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain intensity	100mm Visual Analogue Scale	at T2 (Day 25)	No
Secondary	pain related to movement	100mm Visual Analogue Scale for 6 movement directions (Irnich, BMJ 2001)	at T2 (Day 25)	No
Secondary	pain diary	Daily rating of pain intensity (numeric rating scale from 0-10)	from T0 (Day 0) to T2 (Day25)	No
Secondary	Neck disability index	NDI measures neck pain complaints (Vernon und Mior 1991)	at T2 (Day 25)	No
Secondary	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)	No
Secondary	mechanical detection threshold MDT	by von Frey filaments to measure perception threshold for light touch (Rolke, Pain, 2006)	at T2 (Day 25)	No
Secondary	vibration detection threshold VDT	with a tuning fork to measure perception threshold for vibration (Rolke, Pain, 2006)	at T2 (Day 25)	No
Secondary	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)	No
Secondary	Side effects	open question on any side effects or other experiences with the treatment	from T1 (Day 7) to T2 (Day 25)	Yes
Secondary	Medication diary	patient report used medication during the study period (amount, dose)	From T0 (Day 0) to T2 (Day 25)	No