Clinical trial NCT02651766: The Effects of Cupping Massage in Patients With Chronic Neck Pain - A Randomized Controlled Trial
Official title: Randomised Controlled Trial on the Influence of Cupping Massage on Pain Intensity and Sensory Mechanical and Pain Thresholds in Patients With Chronic Non Specific Neck Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neck Pain
Mechanical/Motor Problems With Neck and Trunk
Lead sponsor: Universität Duisburg-Essen
Sponsor class: OTHER
First posted: 2016-01-11
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 cupping massage treatments on chronic non specific neck pain. 50 patients with neck pain are randomised into cupping treatment and waiting list control group. Before and after the intervention the investigators evaluate the neck pain (VAS), the neck related disability (NDI), pain on movement (POM) and the quality of life (SF36) and safety. To investigate neurophysiological effects of cupping the investigators also measure mechanical detection threshold (MDT), vibration detection threshold (VDT) and pressure pain threshold (PPT) and the two point discrimination threshold at pain related and control areas.

The treatment group receives 5 cupping treatments over a period of 3 weeks.

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)

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: 3 weeks
Secondary outcomes:
measure: Pain on movement (POM)
timeFrame: 3 weeks
measure: Neck disability index
timeFrame: 3 weeks
measure: Quality of Life SF-36
timeFrame: 3 weeks
measure: mechanical detection threshold MDT
timeFrame: 3 weeks
measure: vibration detection threshold VDT
timeFrame: 3 weeks
measure: pressure pain threshold PPT
timeFrame: 3 weeks
measure: Adverse events
timeFrame: 3 weeks
measure: two point discrimination threshold
timeFrame: 3 weeks
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 Dobos, Prof MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Saha FJ, Schumann S, Cramer H, Hohmann C, Choi KE, Rolke R, Langhorst J, Rampp T, Dobos G, Lauche R. The Effects of Cupping Massage in Patients with Chronic Neck Pain - A Randomised Controlled Trial. Complement Med Res. 2017;24(1):26-32. doi: 10.1159/000454872. Epub 2017 Feb 15.
citation: Schumann S, Lauche R, Hohmann C, Zirbes T, Dobos G, Saha FJ. [Development of lipoma following a single cupping massage - a case report]. Forsch Komplementmed. 2012;19(4):202-5. doi: 10.1159/000341869. Epub 2012 Aug 20. German.
citation: Schumann S, Lauche R, Irmisch G, Hohmann C, Rolke R, Saha F, Cramer H, Choi KE, Langhorst J, Rampp T, Dobos G, Musial F. The effects of 5 sessions of cupping massage on chronic non-specific neck pain: A randomized controlled pilot study. BMC Complementary and Alternative Medicine, 2012, 12 (Supplement 1): 80.