Comparative Effectiveness of Particulate Versus Nonparticulate Steroid Injections for Musculoskeletal Conditions

Phase 4

Completed

• Conditions: Impingement Shoulder; Osteoarthritis; Tendinopathy
• Interventions: Drug: Triamcinolone or Betamethasone; Drug: Dexamethasone

• Registration Number: NCT04278833
• Lead Sponsor: Stanford University

Brief Summary

This aims of this study are:

1. To determine if particulate or non-particulate corticosteroid injections are more effective at treating pain from musculoskeletal pathologies of the hip, glenohumeral joint, biceps tendon, or subacromial/subdeltoid bursa at 2 weeks, 3 months, or 6 months.

2. To determine if there is a significantly different side effect profile between particulate and non-particulate corticosteroids when used for hip, glenohumeral joint, biceps tendon, or subacromial/subdeltoid bursa injections.

Detailed Description

This will be a single center, prospective, single blind, randomized controlled trial of hip, glenohumeral joint, peri-tendinous biceps brachii, and subacromial/subdeltoid bursa injections comparing the efficacy of particulate (triamcinolone, betamethasone) versus non-particulate (dexamethasone) corticosteroids.

Participants will be recruited for the study by trained physicians and physician extenders at Stanford orthopedic and PM\&R clinics only after they have already opted for corticosteroid injection as a part of their routine medical care. The initial decision to pursue steroid injection will be based entirely on joint decision making between the patient and their medical provider prior to mention of the study.

After consenting, basic demographic data, average numeric pain score (NRS) over the past week, and information on other medical interventions tried for their pain (including medication use, physical therapy, chiropractic care, and massage) will be collected. The participant will then be randomized to receive either a particulate (triamcinolone or betamethasone) or non-particulate (dexamethasone) corticosteroid, both of which are within current standards of care. Ultrasound or fluoroscopic guided injection will then be completed using sterile technique as per current clinic practice.

After the injection, patients will follow up in clinic or over the phone at 2 weeks, 3 months, and 6 months and will be asked their average NRS over the past week, functional questionnaires appropriate to pertinent body parts (WOMAC, ASES, QDASH), other treatments they have tried in the interim, and for any side effects they have experienced. In addition to obtaining outcome measures, the treating physicians may order repeat injections, medications, or refer the subject to surgery, at their discretion based upon the patient's pain and functional limitations. Up to a total of three injections to the same musculoskeletal structure are allowed during the 6 month study period. Any injection into a separate space (i.e. glenohumeral joint followed by subdeltoid bursa) will be considered different structures, and follow up for the new anatomical site will begin at the time of that injection. Data collection and follow up on the previous anatomical injection site will continue on the same timeline. Data on number and timing of repeat injections, surgeries, side effects, and medications will be recorded as part of the study.

Study Timeline

• Study First Submitted: 2020-02-13
• Study First Submitted QC: 2020-02-19
• Study First Posted: 2020-02-20
• Study Start: 2020-09-01
• Primary Completion: 2021-05-28
• Study Completion: 2021-05-28
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-20
• Last Update Posted: 2024-11-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 165

Inclusion Criteria

• Age greater than or equal to 18
• Ability to provide informed consent
• Capable of complying with the outcome instruments used
• Capable of attending all planned follow up visits
• Patient is deemed appropriate for intra-articular hip, glenohumeral, peri-tendinous biceps, or subdeltoid bursa corticosteroid injection by their treating physician for the treatment of painful musculoskeletal condition
• Average pain of greater than or equal to 4/10 over the last 7 days

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Exclusion Criteria

• Unclear diagnosis
• Pregnancy
• Incarcerated patients
• Prior corticosteroid injection into the same anatomical site within the last 3 months
• Prior prosthetic surgery on the joint
• Any condition that increases injection risk such as bleeding tendencies, uncontrolled diabetes, current active infection, or infection requiring antibiotics within the last 7 days
• Chronic opioid use to control pain
• Workers compensation and litigation
• BMI > 40

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Particulate Corticosteroid Injection	Triamcinolone or Betamethasone	Intra-articular, peri-tendinous, or intra-bursal corticosteroid injection using 10-80mg of triamcinolone or 3-9mg of betamethasone depending on anatomical structure. Injections may be repeated up to 3 times in the 6 month study period based on physician discretion.
Non-particulate Corticosteroid Injection	Dexamethasone	Intra-articular, peri-tendinous, or intra-bursal corticosteroid injection using 4-10mg of dexamethasone depending on anatomical structure. Injections may be repeated up to 3 times in the 6 month study period based on physician discretion.

Primary Outcome Measures

Name	Time	Method
Mean change in average pain from baseline	Baseline and at 2 weeks, 3 months, and 6 months post intervention	Mean change in pain averaged over last 7 days compared to baseline as rated on 11 point numerical rating scale (NRS, score range from 0-10) with higher values indicating worse outcomes.

Secondary Outcome Measures

Name	Time	Method
Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index	Baseline and at 2 weeks, 3 months, and 6 months post intervention	The WOMAC questionnaire will be used for participants who underwent hip injection. The outcome of interest is the mean change in score compared to baseline. The WOMAC is a 24 item scale with scores ranging from 0 to 96, with higher scores indicating worse outcomes.
Quick Disabilities of Arm, Shoulder, and Hand (QDASH)	Baseline and at 2 weeks, 3 months, and 6 months post intervention	The QDASH questionnaire will be used for participants who underwent glenohumeral joint, subdeltoid bursa, or peritendinous biceps injection. The outcome of interest is the mean change in score compared to baseline. The QDASH is an 11 item scale with scores ranging from 0 to 100, with higher scores indicating worse outcomes.
Number of repeat corticosteroid injections	6 months post initial intervention	Total number of corticosteroid injections to the specific anatomical site during the study period. The study protocol allows for a maximum of 3 injections during the 6 month study period based on the treating physician's discretion.
American Shoulder and Elbow Surgeons (ASES) Standardized Shoulder Assessment Form	Baseline and at 2 weeks, 3 months, and 6 months post intervention	The ASES questionnaire will be used for participants who underwent glenohumeral joint, subdeltoid bursa, or peritendinous biceps injection. The outcome of interest is the mean change in score compared to baseline. The ASES is an 11 item scale with scores ranging from 0 to 100, with higher scores indicating better outcomes.
Conversion to surgery	6 months post initial intervention	Percent of participants who were referred for surgical intervention on the specific anatomical site during the study follow up period.

Trial Locations

Locations (1)

Stanford University; 🇺🇸 Redwood City, California, United States