Condition category
Musculoskeletal Diseases
Date applied
25/06/2003
Date assigned
27/10/2003
Last edited
29/08/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Hanns-Peter Scharf

ORCID ID

Contact details

Klinikum der Stadt Mannheim
Theodor-Kutzer-Ufer
Mannheim
68167
Germany

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

GERAC-GA

Study hypothesis

Not provided at time of registration

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Osteoarthritis of the knee (gonarthrosis)

Intervention

Physiotherapy for all participants, additionally three intervention groups:
A. Standard therapy with diclofenac or rofecoxib
B. Defined specific acupuncture regarding Traditional Chinese Medicine (TCM) (verum acupuncture)
C. Defined unspecific acupuncture (sham acupuncture)

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Not provided at time of registration

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/11/2001

Overall trial end date

01/03/2004

Reason abandoned

Eligibility

Participant inclusion criteria

1. Patients (male and female) over 40 with chronic pain (greater than 6 months) due to gonarthrosis (American College of Rheumatology [ACR] criteria)
2. A Kellgren-Lawrence-Score of 2 or 3
3. A Western Ontario and McMaster Universities Arthritis Index (WOMAC) of greater than 3 (scale: 0 - 10)

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

900

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/11/2001

Recruitment end date

01/03/2004

Locations

Countries of recruitment

Germany

Trial participating centre

Klinikum der Stadt Mannheim
Mannheim
68167
Germany

Sponsor information

Organisation

Ruhr University Bochum (Germany)

Sponsor details

Department for Medical Information Technology
Biometry and Epidemiology (AMIB)
c/o Prof. Dr. HJ Trampisch
Overbergstr. 17
Bochum
44780
Germany

Sponsor type

University/education

Website

Funders

Funder type

Government

Funder name

German Health Insurances (AOK, IKK, BKK, Bundesknappschaft, BLK, SKK) (Germany)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Protocol in: http://www.ncbi.nlm.nih.gov/sites/entrez?cmd=Retrieve&db=PubMed&list_uids=15040805

Results in: http://www.ncbi.nlm.nih.gov/sites/entrez?db=pubmed&cmd=Retrieve&dopt=AbstractPlus&list_uids=16818924

Publication citations

  1. Protocol

    Streitberger K, Witte S, Mansmann U, Knauer C, Krämer J, Scharf HP, Victor N, Efficacy and safety of acupuncture for chronic pain caused by gonarthrosis: a study protocol of an ongoing multi-centre randomised controlled clinical trial [ISRCTN27450856]., BMC Complement Altern Med, 2004, 4, 6, doi: 10.1186/1472-6882-4-6.

  2. Results

    Scharf HP, Mansmann U, Streitberger K, Witte S, Krämer J, Maier C, Trampisch HJ, Victor N, Acupuncture and knee osteoarthritis: a three-armed randomized trial., Ann. Intern. Med., 2006, 145, 1, 12-20.

Additional files

Editorial Notes