None listed
Conditions
Brief summary
Basal thumb osteoarthritis is common, painful and debilitating disease with no current prevention or cure. There are a number of surgical options which include bone (trapezium) removal, joint replacement, ligament reconstruction or a combination of these. The recovery is slow, often painful and requires prolonged splinting and physical therapy. Before getting to surgery, conservative treatments include lifestyle modification, taking over the counter pain killers, splinting or occupational hand therapy with mixed success. Corticosteroids injections into the joint can provide pain relief but typically for 3 months only. Hyaluronic acid treatment has proved successful in many joints but often requires multiple injections, increasing the risk of joint infection. A new, stabilised hyaluronic acid is now available that has a longer half life than other hyaluronic compounds, extending its residence in joints and thus its benefit. This hyaluronic acid compound has been shown to relieve pain, improve joint function and help to restore quality of life when injected into knee, shoulder, hip and ankle joints and requires one injection only, avoiding complications associated with multiple injections. These qualities should also be of benefit for the treatment of osteoarthritis symptoms in the basal thumb joint but have yet to be trialed. We aim to conduct a prospective trial to compare hyaluronic acid injections with methylprednisolone acetate (steroid injections) and placebo to see if it reduces pain from osteoarthritis and improves function when injected into the base of thumb joint. We will assess changes in pain and function before and after a once off injection with assessments 2, 4, 12 and 26 weeks after treatment and compare use of pain killers before and after injection by requiring participants to keep a diary of their pain killer usage.
Interventions
The intervention requires an intra-articular injection of one of 3 randomised substances to the participant's carpometacarpal joint with the goal to examine which intervention is the most effective at reducing pain and improving function after a single injection.
Participants will initially receive 2ml of 2% lignocaine injected subcutaneously at the injection site at least four minutes prior to intervention. Participants will be randomised in equal proportions between the following three treatme
The intervention requires an intra-articular injection of one of 3 randomised substances to the participant's carpometacarpal joint with the goal to examine which intervention is the most effective at reducing pain and improving function after a single injection. Participants will initially receive 2ml of 2% lignocaine injected subcutaneously at the injection site at least four minutes prior to intervention. Participants will be randomised in equal proportions between the following three treatment options: a single 1ml injection of 8mg hyaluronic acid (arm 1), a single 1ml injection of 40mg methylprednisolone acetate (arm 2) or a single 1ml injection of sterile saline (arm 3) which will be injected intra-articularly to the first carpometacarpal joint of the affected hand using radiological guidance with a mini c-arm. The injections will be performed by one of two hand surgeons at Plastic Surgery Victoria. Participants will also be given a "pain killer diary" to record their use of analgesia in the 2 weeks prior to and 6 months after their intervention. This diary will be viewed at every visit to monitor adherence.
Sponsors
Prof. Warren Rozen
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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.
Exclusion criteria
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.
Outcome results
None listed