Treatment of Tenosynovitis among rheumatoid arthritis patients
- Conditions
- MedDRA version: 16.0Level: LLTClassification code 10042869Term: Synovitis and tenosynovitisSystem Organ Class: 100000004859Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
- Registration Number
- EUCTR2013-003486-34-DK
- Lead Sponsor
- Knowledge Centre for Rheumatology and Back Diseases
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
Ultrasonic signs of treatment demanding tenosynovitis in flexor or extensor tendons in the hand (1st - 6th compatment) or flexor- , extensor-, or peroneus tendons in the ankle.
Rheumatoid arthritis according to ACR/EULAR 2010 criteria
Above 18 years of age
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 40
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10
Lack of ability to understand the information given about the study.
Recent operation in hands or feet.
Start of Disease-modifying anti-rheumatic drugs (DMARDs) / biological treatment within the last 12 weeks
Change of DMARD / biological or glucocorticoid treatment within the last 6 weeks.
Allergy to betamethasone.
Start of Non-Steroidal Anti-Inflammatory Drugs (NSAID) treatment within the last 10 days.
Systemic fungal infection
Positive urine HCG among women in the age of fertility.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Explore whether ultrasound-guided glucocorticoid injection in the synovial sheath has better effect than intramuscularly glucocorticoid injection among patients with tenosynovitis, assessed by US examination, pain VAS-score and clinical evaluation. ;Secondary Objective: Not applicable;Primary end point(s): Differences in the scoring of tenosynovitis evaluated by US, between treatment arm A and B (US-tenosynovitis scoring = 1 4 weeks after the injektion), assessed by the Mann-Whitney U test.;Timepoint(s) of evaluation of this end point: After the last visit of the last subject.
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Changes in the patient parameters (Clinical and US-sound assessment, as well as the participant’s own reporting and visual Analog Scale for tenosynovitis) assessed by Wilcoxon Pratt test after 2, 4 and 12 weeks.<br><br><br>Correlation between findings (Clinical and US-sound assessment, as well as the participant’s own reporting and visual Analog Scale for tenosynovitis) , assessed by Spearman's correlation analysis after 2, 4 and 12 weeks.<br><br>Differences in the scoring of tenosynovitis evaluated by US, between treatment arm A and B (US-tenosynovitis scoring = 1 12 weeks after the injektion), assessed by the Mann-Whitney U test.<br><br>;Timepoint(s) of evaluation of this end point: After the last visit of the last subject