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

Primary Purpose

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

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Dry Cupping or fire cupping
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)
  • 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.

Sites / Locations

  • Knappschaftskrankenhaus

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

Waiting list control group

Treatment group

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, non standardised application - individual determinations of trigger points

Outcomes

Primary Outcome Measures

Pain intensity
100mm Visual Analogue Scale

Secondary Outcome Measures

pain related to movement
100mm Visual Analogue Scale for 6 movement directions (Irnich, BMJ 2001)
pain diary
Daily rating of pain intensity (numeric rating scale from 0-10)
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
Side effects
open question on any side effects or other experiences with the treatment
Medication diary
patient report used medication during the study period (amount, dose)

Full Information

First Posted
January 31, 2011
Last Updated
August 18, 2011
Sponsor
Universität Duisburg-Essen
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1. Study Identification

Unique Protocol Identification Number
NCT01289964
Brief Title
The Effect of 5 Times Dry Cupping in the Treatment of Chronic Neck Pain
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2009
Overall Recruitment Status
Completed
Study Start Date
July 2009 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
December 2009 (Actual)

3. Sponsor/Collaborators

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 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neck Pain, Neck Pain Musculoskeletal, 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
Treatment group
Arm Type
Active Comparator
Arm Description
Received the 5 cupping treatments, application twice a week, non standardised application - individual determinations of trigger points
Intervention Type
Procedure
Intervention Name(s)
Dry Cupping or fire cupping
Other Intervention Name(s)
Cupping is: heating glas cups to create a vacuum on the skin
Intervention Description
5 dry cupping treatments, application twice a week, non standardised procedure
Primary Outcome Measure Information:
Title
Pain intensity
Description
100mm Visual Analogue Scale
Time Frame
at T2 (Day 25)
Secondary Outcome Measure Information:
Title
pain related to movement
Description
100mm Visual Analogue Scale for 6 movement directions (Irnich, BMJ 2001)
Time Frame
at T2 (Day 25)
Title
pain diary
Description
Daily rating of pain intensity (numeric rating scale from 0-10)
Time Frame
from T0 (Day 0) to T2 (Day25)
Title
Neck disability index
Description
NDI measures neck pain complaints (Vernon und Mior 1991)
Time Frame
at T2 (Day 25)
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
at T2 (Day 25)
Title
mechanical detection threshold MDT
Description
by von Frey filaments to measure perception threshold for light touch (Rolke, Pain, 2006)
Time Frame
at T2 (Day 25)
Title
vibration detection threshold VDT
Description
with a tuning fork to measure perception threshold for vibration (Rolke, Pain, 2006)
Time Frame
at T2 (Day 25)
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
at T2 (Day 25)
Title
Side effects
Description
open question on any side effects or other experiences with the treatment
Time Frame
from T1 (Day 7) to T2 (Day 25)
Title
Medication diary
Description
patient report used medication during the study period (amount, dose)
Time Frame
From T0 (Day 0) to T2 (Day 25)

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) 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gustav J 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
21843336
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.
Results Reference
result

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

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