NCT01289964

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.

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 Jul 2009

Shorter than P25 for not_applicable

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

July 1, 2009

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

January 31, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 4, 2011

Completed
Last Updated

August 19, 2011

Status Verified

July 1, 2009

Enrollment Period

5 months

First QC Date

January 31, 2011

Last Update Submit

August 18, 2011

Conditions

Neck PainNeck Pain MusculoskeletalMechanical/Motor Problems With Neck and Trunk

Outcome Measures

Primary Outcomes (1)

  • Pain intensity

    100mm Visual Analogue Scale

    at T2 (Day 25)

Secondary Outcomes (9)

  • pain related to movement

    at T2 (Day 25)

  • pain diary

    from T0 (Day 0) to T2 (Day25)

  • Neck disability index

    at T2 (Day 25)

  • Quality of Life SF-36

    at T2 (Day 25)

  • mechanical detection threshold MDT

    at T2 (Day 25)

  • +4 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

Treatment group

ACTIVE COMPARATOR

Received the 5 cupping treatments, application twice a week, non standardised application - individual determinations of trigger points

Procedure: Dry Cupping or fire cupping

Interventions

Dry Cupping or fire cuppingPROCEDURE

5 dry cupping treatments, application twice a week, non standardised procedure

Also known as: Cupping is: heating glas cups to create a vacuum on the skin
Treatment group

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)
  • having been in treatment to an orthopaedic or to a neurologist

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 (1)

  • 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.

    PMID: 21843336RESULT

MeSH Terms

Conditions

Neck Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Gustav J 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

Study Record Dates

First Submitted

January 31, 2011

First Posted

February 4, 2011

Study Start

July 1, 2009

Primary Completion

December 1, 2009

Study Completion

December 1, 2009

Last Updated

August 19, 2011

Record last verified: 2009-07

Locations

DE(1)