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The Effects of Cupping Massage in Patients With Chronic Neck Pain - A Randomized Controlled Trial (SKM)

Primary Purpose

Neck Pain, Mechanical/Motor Problems With Neck and Trunk

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Cupping massage
Sponsored by
Universität Duisburg-Essen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neck Pain

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Knappschaftskrankenhaus

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Waiting List control group

Cupping massage treatment

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Pain on movement (POM)
100mm Visual Analogue Scale from 0mm 'no pain' to 100mm 'maximal pain' Intensity rated for 6 movement directions flexion, tension, and rotation
Neck disability index
NDI measures neck pain complaints (Vernon und Mior 1991)
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)
mechanical detection threshold MDT
by von Frey filaments to measure perception threshold for light touch (Rolke, Pain, 2006)
vibration detection threshold VDT
with a tuning fork to measure perception threshold for vibration (Rolke, Pain, 2006)
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
Adverse events
Number of patients with adverse events
two point discrimination threshold
using a pair of circles, determining the distance necessary between those to perceive them as separate sensations

Full Information

First Posted
January 7, 2016
Last Updated
April 30, 2018
Sponsor
Universität Duisburg-Essen
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1. Study Identification

Unique Protocol Identification Number
NCT02651766
Brief Title
The Effects of Cupping Massage in Patients With Chronic Neck Pain - A Randomized Controlled Trial
Acronym
SKM
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

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
May 2009 (undefined)
Primary Completion Date
February 2011 (Actual)
Study Completion Date
February 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universität Duisburg-Essen

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neck Pain, Mechanical/Motor Problems With Neck and Trunk

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Waiting List control group
Arm Type
No Intervention
Arm Description
No treatment within the study period, were allowed to continue physiotherapy and medication. Were offered the treatment after finishing the study
Arm Title
Cupping massage treatment
Arm Type
Experimental
Arm Description
Received the 5 cupping treatments, application twice a week on the upper back and neck
Intervention Type
Procedure
Intervention Name(s)
Cupping massage
Other Intervention Name(s)
Moving cupping treatment
Intervention Description
Using suction on the skin by means of glass cups, and moving the cups after applying massage oil on the skin
Primary Outcome Measure Information:
Title
Pain intensity
Description
100mm Visual Analogue Scale from 0mm 'no pain' to 100mm 'maximal pain'
Time Frame
3 weeks
Secondary Outcome Measure Information:
Title
Pain on movement (POM)
Description
100mm Visual Analogue Scale from 0mm 'no pain' to 100mm 'maximal pain' Intensity rated for 6 movement directions flexion, tension, and rotation
Time Frame
3 weeks
Title
Neck disability index
Description
NDI measures neck pain complaints (Vernon und Mior 1991)
Time Frame
3 weeks
Title
Quality of Life SF-36
Description
the sf-36 is a short form health survey consisting of 8 scales to measure functional health and wellbeing (Bullinger & Kirchberger 1998)
Time Frame
3 weeks
Title
mechanical detection threshold MDT
Description
by von Frey filaments to measure perception threshold for light touch (Rolke, Pain, 2006)
Time Frame
3 weeks
Title
vibration detection threshold VDT
Description
with a tuning fork to measure perception threshold for vibration (Rolke, Pain, 2006)
Time Frame
3 weeks
Title
pressure pain threshold PPT
Description
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
Time Frame
3 weeks
Title
Adverse events
Description
Number of patients with adverse events
Time Frame
3 weeks
Title
two point discrimination threshold
Description
using a pair of circles, determining the distance necessary between those to perceive them as separate sensations
Time Frame
3 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GUstav Dobos, Prof MD
Organizational Affiliation
University of Duisburg-Essen, Chair of Complementary and Integrative Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Knappschaftskrankenhaus
City
Essen
State/Province
NRW
ZIP/Postal Code
45276
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
28219058
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.
Results Reference
background
PubMed Identifier
22964987
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.
Results Reference
result
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.
Results Reference
result

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The Effects of Cupping Massage in Patients With Chronic Neck Pain - A Randomized Controlled Trial

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