Effect of combined conservative therapies on clinical outcomes in patients with thumb base osteoarthritis (COMBO) dataset

Brief Summary

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 .... 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 worldwide. The subtype affecting the base of the thumb, in particular, is probably caused by mechanical factors overloading the joint in addition to genetic predisposition. Debilitating symptoms can occur in this subset of patients, including pain during daily activities such as writing and grasping, loss of hand function and joint stiffness. Due to modest effects, current non-surgical treatment frequently do not meet patients’ demand while surgery is only indicated in cases refractory to conservative therapy due to potential complications. For this reason, the need for novel studies addressing new conservative treatment strategies is emphasized by several reviews. Combination of therapies is often used in clinical practice but little evidence exists about its efficacy. Furthermore, the combination of non-pharmacological and pharmacological rehabilitation interventions has never been studied in the context of patients with thumb base OA. Therefore, the objective of this study is to investigate the effect of a combination of therapies compared to a control group receiving usual care. The new strategy will be delivered over a 6-week period and will consist of education about the disease and joint protection, exercises for the hand, splint for the base of the thumb and use of a topical NSAID. The control group will receive education and instructions on joint protection techniques alone. Read more

Key Inclusion Criteria

- 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 .... - 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 or equal to 2) Read more

Key Exclusion Criteria

- 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 .... - 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 injection in the affected joint in the past 6 months - Intra-articular steroid injection in the affected joint in the past month - Significant injury to the affected joint in the past 6 months - Any other hand pathology that is likely to be contributing to the pain at the base of the thumb (e.g. scaphoid fracture, carpal tunnel syndrome, DeQuervain tendinopathy, trigger thumb, first CMC joint laxity or injury, joint infection, cubital tunnel syndrome, diabetic neuropathy, pain referred from the neck, pain following hand or wrist trauma or surgery) - Poor general health likely to interfere with compliance or assessments, judged by the investigator. - Known hypersensitivity to diclofenac - Current history of advanced renal failure - Past or current history of gastrointestinal ulceration, bleeding and/or perforation - Women who are pregnant or breastfeeding - Current use of any study interventions Read more

Can healthy volunteers participate?

Yes