Intraarticular Application of Opioids versus Glucocorticoids versus Placebo in Gonarthritis

ISRCTN	ISRCTN72633488
DOI	https://doi.org/10.1186/ISRCTN72633488
Secondary identifying numbers	N/A

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

Prof Joachim Sieper
Scientific

Charité Campus Benjamin Franklin
Dept of Rheumatology
Hindenburgdamm 30
Berlin
12200
Germany

Phone	+49 (0)3084454414
Email	joachim.sieper@charite.de

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Treatment
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
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Morphine, Dexamethasone
Primary outcome measure	Improvement of VAS pain of at least 20 mm on a 0-100 scale.
Secondary outcome measures	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.
Overall study start date	01/01/2004
Completion date	01/01/2006

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	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

Charité Campus Benjamin Franklin

Berlin
12200
Germany

Charité - University Medicine Berlin (Charité - Universitätsmedizin Berlin) (Germany)
University/education

Benjamin Franklin Campus
Department of Rheumatology
Hindenburgdamm 30
Berlin
12200
Germany

Research organisation

German Research Foundation (Deutsche Forschungsgemeinschaft) KFO 100

No information available

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan