The Use of Intra-articular Corticosteroid Injection to Treat Osteoarthritis of the Carpometacarpal Joint
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04177433|
Recruitment Status : Recruiting
First Posted : November 26, 2019
Last Update Posted : January 22, 2021
|Condition or disease||Intervention/treatment||Phase|
|Osteoarthritis of the Carpometacarpal Joint Thumb Osteoarthritis||Drug: Depo-Medrol Injectable Product Drug: Saline||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||90 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Outcomes Assessor)|
|Official Title:||The Use of Intra-articular Corticosteroid Injection to Treat Osteoarthritis of the Carpometacarpal Joint: A Randomized Control Trial|
|Actual Study Start Date :||December 2, 2020|
|Estimated Primary Completion Date :||January 29, 2022|
|Estimated Study Completion Date :||January 29, 2023|
Experimental: 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.
Drug: Depo-Medrol Injectable Product
Placebo Comparator: 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.
- 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.
- Change in Quick Disabilities of the Arm, Shoulder and Hand (Quick-DASH) Questionnaire [ Time Frame: baseline, 6 weeks, 3 months, 6 months ]it's a 11-item, patient-reported questionnaire that measures the function and psychosocial impact of upper extremity musculoskeletal conditions in patients' quality of life. It is scored between 0 (no disability) and 100(very disable). The minimal important change expected is a 10-point difference in mean DASH score among groups.
- Change in Michigan Hand Outcomes Questionnaire [ Time Frame: baseline, 6 weeks, 3 months, 6 months ]It is a 37-item self-administered questionnaire that assess function, appearance, pain, and satisfaction in patients with hand and wrist conditions and injuries, including arthritis. It is scored between 1 (very good/not at all difficult/always/very mild/very satisfied) to 5 (very poor/very difficult/never/severe/very dissatisfied). The minimal important change expected is a 3-point difference for pain, 11-points difference for function and 13-point difference for activities of daily living (ADL) between groups.
- Change in Pinch Strength [ Time Frame: baseline, 6 weeks, 3 months, 6 months ]Pinch strength will be measured with a mechanical pinch gauge that is a reliable and valid method to detect difference in thumb strength. Pinch strength will be measured using the following standard positions: 1) Tip pinch: pinch between the thumb and index finger, and 2) Tripod pinch: pinch between the thumb, index and middle fingers. A minimal difference of 0.33 kg for tip and 0.35 kg for tripod pinch among groups will be considered clinically important.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04177433
|Contact: Anelise Silveira, PT, MScfirstname.lastname@example.org|
|Contact: Lauren Beaupre, PhDemail@example.com|
|Western Upper Limb Facility, Sturgeon Community Hospital||Recruiting|
|St. Albert, Alberta, Canada, T8N 6C4|
|Contact: Anelise Silveira|