Efficacy and safety of acupuncture with chronic pain caused by osteoarthritis of the knee (gonarthrosis): a multi-centre and randomised controlled clinical trial
| ISRCTN | ISRCTN27450856 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN27450856 |
| Protocol serial number | N/A |
| Sponsor | Ruhr University Bochum (Germany) |
| Funder | German Health Insurances (AOK, IKK, BKK, Bundesknappschaft, BLK, SKK) (Germany) |
- Submission date
- 25/06/2003
- Registration date
- 27/10/2003
- Last edited
- 29/08/2007
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Hanns-Peter Scharf
Scientific
Scientific
Klinikum der Stadt Mannheim
Theodor-Kutzer-Ufer
Mannheim
68167
Germany
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study acronym | GERAC-GA |
| Study objectives | Not provided at time of registration |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure(s) |
Not provided at time of registration |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 01/03/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target sample size at registration | 900 |
| Key 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) |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/11/2001 |
| Date of final enrolment | 01/03/2004 |
Locations
Countries of recruitment
- Germany
Study participating centre
Klinikum der Stadt Mannheim
Mannheim
68167
Germany
68167
Germany
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | Results | 04/07/2006 | Yes | No | |
| Protocol article | Protocol | 24/03/2004 | Yes | No |
