The Use of Intra-articular Corticosteroid Injection to Treat Osteoarthritis of the Carpometacarpal Joint

NCT04177433 | Completed Phase 4

• 1 other identifier: Pro00092745
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoarthritis of the Carpometacarpal Joint; Thumb Osteoarthritis

Keywords

Basal thumb arthritis; Carpometacarpal arthritis; Steroid injection; Thumb osteoarthritis

Outcome Measures

Primary Outcomes (1)

• Change in Pain with movement

  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.

  baseline, 6 weeks, 3 months, 6 months

Secondary Outcomes (5)

• Change in Quick Disabilities of the Arm, Shoulder and Hand (Quick-DASH) Questionnaire

  baseline, 6 weeks, 3 months, 6 months

• 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

• Thumb Range of Motion

  Baseline, 6 weeks, 3 months, 6 months

• Conversion to Surgery

  From enrollment to December 31, 2025.

Study Arms (2)

Corticosteroid Injection

EXPERIMENTAL

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

Saline

PLACEBO COMPARATOR

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.

Drug: Saline

Interventions

Depo-Medrol Injectable Product DRUG

Corticosteroid

Corticosteroid Injection

Saline DRUG

Placebo

Saline

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Alberta: lead

Study Sites (1)

Western Hand & Upper Limb Facility, Sturgeon Community Hospital

St. Albert, Alberta, T8N 6C4, Canada

Location

MeSH Terms

Interventions

Sodium Chloride

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2019
• First Posted: November 26, 2019
• Study Start: December 2, 2020
• Primary Completion: September 29, 2025
• Study Completion: December 31, 2025
• Last Updated: April 2, 2026

Record last verified: 2026-03

Locations

CA (1)