Randomised controlled trial for the treatment of hand arthrosis with prednisolone and naproxen

ISRCTN	ISRCTN68990076
DOI	https://doi.org/10.1186/ISRCTN68990076
Protocol serial number	IDS 04-05
Sponsor	Vienna Medical University (Austria)
Funder	Vienna Medical University (Austria)

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 Josef Smolen
Scientific

Department of Internal Medicine III
Division of Rheumatology
Wahringer Gurtel 18-20
Vienna
A-1090
Austria

Phone	+43 (0)140 400 4381
Email	josef.smolen@wienkav.at

Primary study design	Interventional
Study design	Single-centre, randomised, double-blind, placebo-controlled clinical trial
Secondary study design	Randomised controlled trial
Scientific title
Study acronym	BELIOA2
Study objectives	The primary hypothesis is that patients with hand arthrosis treated with prednisolone for one week (3 days 50 mg, 4 days 25 mg) will improve significantly in different clinical parameters
Ethics approval(s)	The study was approved by the Internal Review Board and Ethical Committee of the Vienna Medical University on 14/02/2006, reference number 481/2005
Health condition(s) or problem(s) studied	Hand arthrosis
Intervention	Patients are randomised to receive treatment with either prednisolone or naproxen or placebo
Intervention type	Drug
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Prednisolone and naproxen
Primary outcome measure(s)	Pain in the target hand measured on a 100 mm VAS
Key secondary outcome measure(s)	1. Morning stiffness 2. VAS for disease activity 3. Tender and swollen joint counts (inflammatory and bony swelling) 4. Functioning measured with: a. Health Assessment Questionnaire (HAQ) b. Score for Assessment and Quantification of Chronic Rheumatic Affections of the Hands (SACRAH) c. Arthritis Impact Measurement Scales 2 - Short Form (AIMS2-SF) d. Grip strength e. Moberg picking-up test
Completion date	01/12/2006

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	246
Key inclusion criteria	1. Hand arthrosis 2. Age over 18 years 3. Pain on a 100 mm Visual Analogue Scale (VAS) in the target hand more than 40 mm 4. Willingness to comply with the protocol
Key exclusion criteria	1. Current treatment with steroids 2. Cardiac insufficiency 3. Infection 4. Uncontrolled hypertension 5. History of gastrointestinal bleeding 6. Diabetes mellitus 7. Allergy against study medication 8. Pregnancy
Date of first enrolment	01/12/2005
Date of final enrolment	01/12/2006

Department of Internal Medicine III

Vienna
A-1090
Austria

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan