Clinical trial NCT01289964: The Effect of 5 Times Dry Cupping in the Treatment of Chronic Neck Pain
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neck Pain
Neck Pain Musculoskeletal
Mechanical/Motor Problems With Neck and Trunk
Lead sponsor: Universität Duisburg-Essen
Sponsor class: OTHER
First posted: 2011-02-04
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: see above

Eligibility 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.

Primary outcomes:
measure: Pain intensity
timeFrame: at T2 (Day 25)
Secondary outcomes:
measure: pain related to movement
timeFrame: at T2 (Day 25)
measure: pain diary
timeFrame: from T0 (Day 0) to T2 (Day25)
measure: Neck disability index
timeFrame: at T2 (Day 25)
measure: Quality of Life SF-36
timeFrame: at T2 (Day 25)
measure: mechanical detection threshold MDT
timeFrame: at T2 (Day 25)
measure: vibration detection threshold VDT
timeFrame: at T2 (Day 25)
measure: pressure pain threshold PPT
timeFrame: at T2 (Day 25)
measure: Side effects
timeFrame: from T1 (Day 7) to T2 (Day 25)
measure: Medication diary
timeFrame: From T0 (Day 0) to T2 (Day 25)
Other outcomes:
Locations:
city: Essen
country: Germany
facility: Knappschaftskrankenhaus
state: NRW
Study officials:
affiliation: University of Duisburg-Essen, Chair of Complementary and Integrative Medicine
name: Gustav J Dobos, Prof. MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.