Effectiveness of intra-articular hyaluronic acid compared to corticosteroid or placebo injections to treat basal thumb osteoarthritis: a prospective, randomised, blinded clinical study

Prof. Warren Rozen0 sites90 target enrollmentJuly 13, 2020

Overview

No summary available.

Registry

who.int

Start Date

July 13, 2020

End Date

TBD

Last Updated

5 years ago

Study Type

Interventional

Sex

All

Sponsor

Prof. Warren Rozen

•Participants eligible for the trial must comply with all of the following at randomization:
•1\.Age greater or equal to 40 years
•2\.Symptomatic 1st carpometacarpal osteoarthritis requiring non\-operative treatment, diagnosed by both standard clinical and radiographic measures as below
•a.Clinical osteoarthritis includes the following
•i.History of carpometacarpal tenderness, thumb or wrist pain at rest or with activity, joint stiffness or decreased function
•ii.Examination yielding dorsoradial prominence of the thumb metacarpal base, tenderness over the joint, crepitus, positive grind” test or positive distraction” test
•b.Radiographic evidence of osteoarthritis of any Eaton\-Littler\-Burton classification
•Patients who have received previous injections to the carpometacarpal joint to be treated of either hyaluronic acid or steroid will be included if they have had 1 or 2 prior injections with reported improvement in pain and function after the injections as they will be likely to have benefit from a further injection.

•1\.Prior surgery to affected thumb/wrist
•2\.Injury to joint in last 6 months
•3\.Prior or current infection in affected joint
•4\.History of inflammatory arthritis or skin disease at the injection site
•5\.Pre\-existing chondrocalcinosis, thoracic outlet syndrome, carpal tunnel syndrome, Guyon’s canal syndrome, cubital tunnel syndrome, diabetic neuropathy or cheiroarthropathy, palmar tenosynovitis, trigger thumb, fibromyalgia, pain syndrome, psoriasis
•6\.Pregnant or lactating women
•7\.Known allergy to local anaesthetic, cortisone or hyaluronic acid derivative products
•8\.Visual Analogue Scale \<40mm
•9\.Regular opiate use for a concomitant condition or analgesics unless stable dosage for over or equal to 1 month
•10\.If participants have had more than 2 injections of either hyaluronic acid or corticosteroid to the first carpometacarpal joint or an injection in the last 6 months.