COMBO
ACTRN12616000353493
Treatment
Not Applicable
Government body,National Health and Medical Research Council
Dr Sarah Rubia Robbins
Osteoarthritis (OA) is a chronic disorder affecting the joints, most commonly involving the hands, knees and hips. In view of the strong association of OA with ageing, major concerns with the disease exist due to the continuous rise in the number of elderly. Pain is the most common symptom in addition to progressive difficulty or incapacity to perform daily activities. Among the different disease phenotypes, OA of the hands is a frequent condition, causing symptoms in up to 15% of the population .... Read more
- Age greater than or equal to 40 years - Clinical diagnosis of OA in the first CMC joint in at least one hand - Chronic pain at the base of the thumb at least half of the days in the past month and at least 48 hours prior to the screening visit - Average VAS pain greater than or equal to 40 out of 100 (range, 0 – 100) over past 30 days - FIHOA scores greater than or equal to 6 (range, 0 - 30) - Radiographic evidence of OA in the first CMC joint read by a trained rheumatologist (KLG greater than .... Read more
- Known diagnosis of crystal-related arthritis (e.g. gout, CPPD), autoimmune arthritis (e.g. rheumatoid arthritis, psoriatic arthritis), hemochromatosis or fibromyalgia - Hand surgery in the last 6 months or planning to undergo surgery in the next 6 months - Use of concomitant medications potentially directed at OA, unless at a stable dosage for at least 1 month for analgesics and NSAIDs or 3 months for slow acting symptomatic or structure modifying drugs - Intra-articular hyaluronic acid inject .... Read more
Yes
Sample Size 204
Min. age 40 Years
Max. age No limit
Sex Both males and females
Condition category thumb base osteoarthritis
Condition code Musculoskeletal
Intervention code Treatment: Devices , Treatment: Drugs , Treatment: Other
The intervention will be composed of four components: EDUCATION ABOUT THE DISEASE AND JOINT PROTECTION TECHNIQUES All participants will be provided with education about disease and joint protection techniques through an educational brochure delivered at baseline and through face-to-face meetings of approximately 30 minutes each with the study therapist at baseline and 2-week visit. The brochure and the visit will aim to provide information about the disease including: diagnosis, disease course, .... Read more
Control group Active
The control group will be provided with education about disease and joint protection techniques through an educational brochure delivered at baseline and through face-to-face meetings of approximately 30 minutes each with the study therapist at baseline and 2-week visit. The brochure and the visit will aim to provide information about the disease including: diagnosis, disease course, objectives of treatment, self-management and instruction in joint protection techniques. The brochure was develop .... Read more
Outcome: Change in pain level at the base of the thumb assessed by the visual analogue scale (VAS) (range, 0-100mm)Timepoint: Baseline, and at 6 weeks after intervention commencement
Outcome: Change in hand function assessed by the Functional index for hand osteoarthritis (FIHOA)Timepoint: Baseline, and at 6 weeks after intervention commencement
yes
We will share the data of 196 consented participants including demographics, clinical characteristics and outcome measures at baseline, weeks 2, 6 and 12.
After a secondary researcher proposal has been approved by the data custodians. Data are available for an indefinite time.
Researchers interested in using IPD for future studies
Any type of analyses