The Use of Intra-articular Corticosteroid Injection to Treat Osteoarthritis of the Carpometacarpal Joint: A Randomized Control Trial
Trial Snapshot
- Phase
- Phase 4
- Status
- Active, not recruiting
- Sponsor
- University of Alberta
- Enrollment
- 90
- Locations
- 1
- Primary Endpoint
- Change in Pain with movement
Study Overview
Brief Summary
This randomized clinical trial (RCT) will evaluate 6-month outcomes following intra-articular injections for arthritis of the thumb carpometacarpal (CMC) joint by comparing corticosteroid plus local anesthetic versus saline (placebo) plus local anesthetic.
Detailed Description
Background & Significance:
The burden of chronic diseases such as osteoarthritis (OA) is increasing globally, having a major impact on both health services and society. 1,2 The CMC joint of the thumb is the most commonly affected joint in the upper extremity by OA, and may lead to pain, decreased hand function and poor health-related quality of life. 3-6 The prevalence of CMC OA varies depending on the population being studied and is not yet well defined. Haara et al. 6 reported age-adjusted CMC OA prevalence of 7% in men and 15% in women among adults thirty years of age or older in Finland. The ROTTERDAM study7 showed that 67% of the women and 54.8% of the men had OA in at least one hand joint, with 35.8% occurring at the CMC joint. The Framingham Study reported higher prevalence of symptomatic hand OA in women (26.2%) compared to men (13.4%) aged 70 year or older. Symptomatic participants in this cohort had 10% reduced maximal grip strength, reported more difficulty with activities of daily living such as writing, handling, or fingering small objects (odds ratio = 3.4), and increased difficulty lifting over 10-pound objects (odds ratio = 1.7 and 1.6, respectively).8
Treating CMC OA is challenging, since evidence is contradictory. A study looking at the natural history of hand OA over a 6 year period showed variation in pain and functional changes, with half of the population reporting deterioration of symptoms and the other half reporting improvements of outcomes with different treatments. 9 Clinical changes (pain and function) and radiographic progression of CMC OA were not related in this study. 9 Non-operative management (i.e. splints, medications, physiotherapy) is usually the first choice of treatment for symptomatic CMC OA, followed by surgery if failed non-operative management. 3,10 Current non-operative guidelines for treatment of hand OA are based on a combination of research findings and expertise opinion. 11-13 2007EULAR, 2012 American College of Rheumatology and 2014 NICE guidelines recommendations for the treatment of hand OA include general considerations (i.e. clinical presentation, risk factors and associated diseases), non-pharmacological (i.e. splint, education, exercises, thermal modalities), and pharmacological (i.e. pain medications, oral and topical anti-inflammatories, opioids) approaches. 11-13 2007EULAR and 2014 NICE also recommend intra-articular corticosteroid injections as an adjunct treatment if patients didn't respond to other treatment approaches, even though evidence is weak.11,13
Effectiveness of guided intra-articular injections for CMC OA evidence is inconsistent. There is only one published RCT looking specifically at efficacy of corticosteroid injections in CMC OA that found no clinical benefit from intra-articular corticosteroid injection to moderate to severe CMC OA compared with placebo injection. This study ended earlier due to recruitment issues and is underpowered to detect true differences between groups. 14 A meta-analysis investigating intra-articular injections of corticosteroids or hyaluronic acid in thumb OA stated that corticosteroids may be helpful in decreasing pain and hyaluronic acid in improving pulp pinch force in a period of 5 to 6 months. 15 Due to high heterogeneity of included studies in this meta-analysis, the evidence is still inconclusive. Another RCT compared the efficacy of intra-articular hyaluronic acid and corticoid injections in CMC OA and found that both study groups had decreased pain and improved function when compared to baseline data, with no significant differences between groups. 16 A recent systematic review on non-surgical therapies for hand OA found inconsistent evidence when comparing intra-articular steroids and placebo. 17 They found three RCTs comparing intra-articular steroids to placebo, with two studies showing no difference and one study showing significant improvement in pain with movement between groups.17
Based on the lack of strong evidence regarding the use of guided corticosteroid injections to treat CMC OA, this randomized clinical trial (RCT) will compare 6-months outcomes following fluoroscopic guided injections of corticosteroid plus local anesthetic or saline (placebo) plus local anesthetic in adult participants with carpometacarpal osteoarthritis (OA).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Participants must be 18 years old or older at recruitment
- •Present clinical and radiographic signs of thumb CMC OA using the American College of Rheumatology (ACR) criteria for the classification of hand osteoarthritis.
Exclusion Criteria
- •History of inflammatory arthritis
- •Previous steroid joint injection to either thumb CMC joint
- •Pregnancy or breastfeeding
- •Psychiatric illness
- •Cognitive impairment, or health conditions that preclude informed consent or receiving the injection
- •People who do not speak/read/understand English, have no fixed address or contact, or are unwilling to complete follow-ups
Arms & Interventions
Corticosteroid Injection
Pre-filled opaque syringe containing 40 mg (1cc) of depo-medrol combined with 0.5 cc of 1% lidocaine (or 1cc saline + 0.5 cc 1% lidocaine) will be injected in the symptomatic CMC joint using fluoroscopic imaging to ensure injection into the joint. If both CMC joints are symptomatic, the most symptomatic joint will be injected. If both CMC joints are equally symptomatic, the dominant hand will be injected.
Intervention: Depo-Medrol Injectable Product (Drug)
Saline
Pre-filled opaque syringe containing 0.5 cc of 1% lidocaine (or 1cc saline + 0.5 cc 1% lidocaine) will be injected in the symptomatic CMC joint using ultrasound imaging to ensure accuracy of injected location. If both CMC joints are symptomatic, the most symptomatic joint will be injected. If both CMC joints are equally symptomatic, the dominant hand will be injected.
Intervention: Saline (Drug)
Outcomes
Primary Outcomes
Change in Pain with movement
Time Frame: baseline, 6 weeks, 3 months, 6 months
Pain will be assessed using Visual Analogue Scale (VAS) where zero equaled no pain and 10 the worst possible pain. a minimal difference of 20 mm (20%) between groups will be considered clinically important.
Secondary Outcomes
- Change in Brief Michigan Hand Outcomes Questionnaire(baseline, 6 weeks, 3 months, 6 months)
- Change in Pinch Strength(baseline, 6 weeks, 3 months, 6 months)
- Change in Quick Disabilities of the Arm, Shoulder and Hand (Quick-DASH) Questionnaire(baseline, 6 weeks, 3 months, 6 months)
