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

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ClinicalTrials.gov Identifier: NCT04177433
Recruitment Status : Recruiting
First Posted : November 26, 2019
Last Update Posted : January 22, 2021
Sponsor:
Information provided by (Responsible Party):
Shoulder & Upper Extremity Research Group of Edmonton

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.

Condition or disease Intervention/treatment Phase
Osteoarthritis of the Carpometacarpal Joint Thumb Osteoarthritis Drug: Depo-Medrol Injectable Product Drug: Saline Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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
Corticosteroid

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.
Drug: Saline
Placebo




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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.

  2. 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.

  3. 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.



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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Participants must be 40 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

Information from the National Library of Medicine

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


Contacts
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Contact: Anelise Silveira, PT, MSc 780-492-2398 anelise.silveira@ahs.ca
Contact: Lauren Beaupre, PhD 780-492-2686 lauren.beaupre@ahs.ca

Locations
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Canada, Alberta
Western Upper Limb Facility, Sturgeon Community Hospital Recruiting
St. Albert, Alberta, Canada, T8N 6C4
Contact: Anelise Silveira         
Sponsors and Collaborators
Shoulder & Upper Extremity Research Group of Edmonton
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Responsible Party: Shoulder & Upper Extremity Research Group of Edmonton
ClinicalTrials.gov Identifier: NCT04177433    
Other Study ID Numbers: Pro00092745
First Posted: November 26, 2019    Key Record Dates
Last Update Posted: January 22, 2021
Last Verified: January 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Shoulder & Upper Extremity Research Group of Edmonton:
Basal thumb arthritis
Carpometacarpal arthritis
Steroid injection
Thumb osteoarthritis
Additional relevant MeSH terms:
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Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Methylprednisolone
Methylprednisolone Acetate
Methylprednisolone Hemisuccinate
Prednisolone
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Neuroprotective Agents
Protective Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents