Effect of combined conservative therapies on clinical outcomes in patients with thumb base osteoarthritis: a randomised, controlled trial (COMBO)

Not Applicable

Completed

• Conditions: thumb base osteoarthritis; Musculoskeletal - Osteoarthritis

• Registration Number: ACTRN12616000353493
• Lead Sponsor: The University of Sydney a body corporate established pursuant to the University of Sydney Act 1989 represented and acting through the Dept of Rheumatology, Northern Clinical School

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-03-18
• Study Completion: 2019-05-21
• Last Update Posted: 15 May 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 204

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 or equal to 2)

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 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified