NCT02651766

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2009

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2011

Completed
4.9 years until next milestone

First Submitted

Initial submission to the registry

January 7, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 11, 2016

Completed
Last Updated

May 2, 2018

Status Verified

April 1, 2018

Enrollment Period

1.8 years

First QC Date

January 7, 2016

Last Update Submit

April 30, 2018

Conditions

Neck PainMechanical/Motor Problems With Neck and Trunk

Outcome Measures

Primary Outcomes (1)

  • Pain intensity

    100mm Visual Analogue Scale from 0mm 'no pain' to 100mm 'maximal pain'

    3 weeks

Secondary Outcomes (8)

  • Pain on movement (POM)

    3 weeks

  • Neck disability index

    3 weeks

  • Quality of Life SF-36

    3 weeks

  • mechanical detection threshold MDT

    3 weeks

  • vibration detection threshold VDT

    3 weeks

  • +3 more secondary outcomes

Study Arms (2)

Waiting List control group

NO INTERVENTION

No treatment within the study period, were allowed to continue physiotherapy and medication. Were offered the treatment after finishing the study

Cupping massage treatment

EXPERIMENTAL

Received the 5 cupping treatments, application twice a week on the upper back and neck

Procedure: Cupping massage

Interventions

Cupping massagePROCEDURE

Using suction on the skin by means of glass cups, and moving the cups after applying massage oil on the skin

Also known as: Moving cupping treatment
Cupping massage treatment

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Knappschaftskrankenhaus

Essen, North Rhine-Westphalia, 45276, Germany

Location

Related Publications (3)

  • 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.

    PMID: 28219058BACKGROUND

  • 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.

    PMID: 22964987RESULT

  • 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.

    RESULT

MeSH Terms

Conditions

Neck Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • GUstav Dobos, Prof MD

    University of Duisburg-Essen, Chair of Complementary and Integrative Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle investigator

Study Record Dates

First Submitted

January 7, 2016

First Posted

January 11, 2016

Study Start

May 1, 2009

Primary Completion

February 1, 2011

Study Completion

February 1, 2011

Last Updated

May 2, 2018

Record last verified: 2018-04

Locations

DE(1)