Intraarticular Application of Opioids versus Glucocorticoids versus Placebo in Gonarthritis
| ISRCTN | ISRCTN72633488 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN72633488 |
| Protocol serial number | N/A |
| Sponsor | Charité - University Medicine Berlin (Charité - Universitätsmedizin Berlin) (Germany) |
| Funder | German Research Foundation (Deutsche Forschungsgemeinschaft) KFO 100 |
- Submission date
- 24/08/2005
- Registration date
- 21/10/2005
- Last edited
- 06/02/2008
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Joachim Sieper
Scientific
Scientific
Charité Campus Benjamin Franklin
Dept of Rheumatology
Hindenburgdamm 30
Berlin
12200
Germany
| Phone | +49 (0)3084454414 |
|---|---|
| joachim.sieper@charite.de |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | Assessment of efficacy and safety of intraarticular applicated Morphine versus Dexamethasone versus Placebo in gonarthritis in inflammatory rheumatic disease |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Gonarthritis in inflammatory rheumatic disease |
| Intervention | Single injection of Morphine 3 mg or Dexamethasone 4 mg or Placebo during needle arthroscopy. Rearthroscopy after 7 days. |
| Intervention type | Drug |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Morphine, Dexamethasone |
| Primary outcome measure(s) |
Improvement of VAS pain of at least 20 mm on a 0-100 scale. |
| Key secondary outcome measure(s) |
Impovement of a numeric pain scale, sleep quality, global daily activity, knee mobility with Lysholm and Gilquist Score, Western Ontario McMaster Universities Osteoarthritis (WOMAC) index, relief of pain on a numeric scale from 0-3. |
| Completion date | 01/01/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 60 |
| Key inclusion criteria | 1. Age 19-70 2. Gonarthritis with sonographically evident effusion in inflammatory rheumatic disease 3. Visual analogue score (VAS) pain >30 mm 4. Body weight 50-90 kg 5. Written informed consent |
| Key exclusion criteria | 1. Pregnancy, lactation 2. Severe or opportunistic infection, infection of the knee 3. Malignant diseases 4. Any other severe diseases 5. Platelets <100/nl, Quick <50 6. Significant findings during clinical examination 7. Participation in a clinical trial within 30 days before inclusion 8. Abuse of hard drugs, benzodiacepines, analgesics, alcohol 9. Therapy with anticoagulants |
| Date of first enrolment | 01/01/2004 |
| Date of final enrolment | 01/01/2006 |
Locations
Countries of recruitment
- Germany
Study participating centre
Charité Campus Benjamin Franklin
Berlin
12200
Germany
12200
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 |
