Comparative Effectiveness of Particulate Versus Nonparticulate Steroid Injections for Musculoskeletal Conditions

NCT04278833 | Terminated Phase 4 Results FDA Drug

• 1 other identifier: 54336
• Study Type: interventional
• Target: 165
• Locations: 1 country
• Sites: 1

Brief Summary

This aims of this study are:

1. 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. 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.

Conditions

Osteoarthritis; Tendinopathy; Impingement Shoulder

Keywords

corticosteroid injection; particulate steroid; non-particulate steroid

Outcome Measures

Primary Outcomes (2)

• Mean Change in Average Pain From Baseline

  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.

  Baseline and at 2 weeks, 3 months, and 6 months post intervention

• Number of Participants With ≥50% Decrease in Pain From Baseline

  Decrease in pain compared to baseline as rated on 11 point numerical rating scale (NRS, score range from 0-10) with higher values indicating worse outcomes.

  Baseline and at 2 weeks, 3 months, and 6 months post intervention

Secondary Outcomes (5)

• Change in Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index

  Baseline and at 2 weeks, 3 months, and 6 months post intervention

• Change in Quick Disabilities of Arm, Shoulder, and Hand (QDASH)

  Baseline and at 2 weeks, 3 months, and 6 months post intervention

• Change in American Shoulder and Elbow Surgeons (ASES) Standardized Shoulder Assessment Form

  Baseline and at 2 weeks, 3 months, and 6 months post intervention

• Number of Participants With Repeat Corticosteroid Injections

  6 months post initial intervention

• Number of Participants Referred for Surgical Intervention (Conversion to Surgery)

  6 months post initial intervention

Study Arms (2)

Particulate Corticosteroid Injection

OTHER

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.

Drug: Triamcinolone or Betamethasone

Non-particulate Corticosteroid Injection

OTHER

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.

Drug: Dexamethasone

Interventions

Triamcinolone or Betamethasone DRUG

Image guided intra-articular, peri-tendinous, or intra-bursal corticosteroid injection

Also known as: Particulate Steroid

Particulate Corticosteroid Injection

Dexamethasone DRUG

Image guided intra-articular, peri-tendinous, or intra-bursal corticosteroid injection

Also known as: Non-Particulate Steroid

Non-particulate Corticosteroid Injection

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University

Redwood City, California, 94063, United States

Location

Related Publications (17)

• Buchbinder R, Green S, Forbes A, Hall S, Lawler G. Arthrographic joint distension with saline and steroid improves function and reduces pain in patients with painful stiff shoulder: results of a randomised, double blind, placebo controlled trial. Ann Rheum Dis. 2004 Mar;63(3):302-9. doi: 10.1136/ard.2002.004655.

  PMID: 14962967 BACKGROUND

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  PMID: 29511701 BACKGROUND

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  PMID: 19770605 BACKGROUND

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  PMID: 26095339 BACKGROUND

• Derby R, Lee SH, Date ES, Lee JH, Lee CH. Size and aggregation of corticosteroids used for epidural injections. Pain Med. 2008 Mar;9(2):227-34. doi: 10.1111/j.1526-4637.2007.00341.x.

  PMID: 18298706 BACKGROUND

• Dreyfuss P, Baker R, Bogduk N. Comparative effectiveness of cervical transforaminal injections with particulate and nonparticulate corticosteroid preparations for cervical radicular pain. Pain Med. 2006 May-Jun;7(3):237-42. doi: 10.1111/j.1526-4637.2006.00162.x.

  PMID: 16712623 BACKGROUND

• Hajialilo M, Ghorbanihaghjo A, Valaee L, Kolahi S, Rashtchizadeh N, Amirkhiz MB, Malekmahdavi I, Khabbazi A. A double-blind randomized comparative study of triamcinolone hexacetonide and dexamethasone intra-articular injection for the treatment of knee joint arthritis in rheumatoid arthritis. Clin Rheumatol. 2016 Dec;35(12):2887-2891. doi: 10.1007/s10067-016-3397-4. Epub 2016 Aug 29.

  PMID: 27572327 BACKGROUND

• Hong JY, Yoon SH, Moon DJ, Kwack KS, Joen B, Lee HY. Comparison of high- and low-dose corticosteroid in subacromial injection for periarticular shoulder disorder: a randomized, triple-blind, placebo-controlled trial. Arch Phys Med Rehabil. 2011 Dec;92(12):1951-60. doi: 10.1016/j.apmr.2011.06.033. Epub 2011 Oct 25.

  PMID: 22030233 BACKGROUND

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  PMID: 24393129 BACKGROUND

• Laemmel E, Segal N, Mirshahi M, Azzazene D, Le Marchand S, Wybier M, Vicaut E, Laredo JD. Deleterious Effects of Intra-arterial Administration of Particulate Steroids on Microvascular Perfusion in a Mouse Model. Radiology. 2016 Jun;279(3):731-40. doi: 10.1148/radiol.2015142746. Epub 2016 Jan 13.

  PMID: 26761719 BACKGROUND

• Lambert RG, Hutchings EJ, Grace MG, Jhangri GS, Conner-Spady B, Maksymowych WP. Steroid injection for osteoarthritis of the hip: a randomized, double-blind, placebo-controlled trial. Arthritis Rheum. 2007 Jul;56(7):2278-87. doi: 10.1002/art.22739.

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  PMID: 27915069 BACKGROUND

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• Roh YH, Yi SR, Noh JH, Lee SY, Oh JH, Gong HS, Baek GH. Intra-articular corticosteroid injection in diabetic patients with adhesive capsulitis: a randomized controlled trial. Knee Surg Sports Traumatol Arthrosc. 2012 Oct;20(10):1947-52. doi: 10.1007/s00167-011-1776-6. Epub 2011 Nov 24.

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  PMID: 23507791 BACKGROUND

MeSH Terms

Conditions

Osteoarthritis; Tendinopathy; Shoulder Impingement Syndrome

Interventions

Triamcinolone; Betamethasone; Dexamethasone

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Muscular Diseases; Tendon Injuries; Wounds and Injuries; Shoulder Injuries

Intervention Hierarchy (Ancestors)

Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Pregnadienetriols

Limitations and Caveats

Early termination led to a small number of hip injection participants analyzed.

Results Point of Contact

• Title: Clinical Research Coordinator
• Organization: Stanford University

jessn16@stanford.edu

(650) 723-0003

Study Officials

• Eugene Roh, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will be blinded to the type of corticosteroid (particulate or non-particulate) that they receive.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Associate Professor

Model Details: Single center, prospective, single blind, randomized controlled trial of hip, glenohumeral joint, biceps tendon, and subacromial bursa injections comparing the efficacy of particulate (triamcinolone, betamethasone) vs non-particulate (dexamethasone) steroids. Participants will be recruited at Stanford orthopedic and PM\&R clinics only after they have already opted for steroid injection as a part of their medical care. They will be randomized to receive either a particulate or non-particulate corticosteroid, then image-guided injection will be completed as per current clinic practice. Patients will follow up in clinic or via phone at 2 weeks, 3 months, and 6 months and will be asked their NRS score, functional questionnaires, other treatments they have tried, and for any side effects experienced. The treating physician may order repeat injections, medications, or refer to surgery, at their discretion. Up to three injections to the same structure are allowed during the study period.

Study Record Dates

• First Submitted: February 13, 2020
• First Posted: February 20, 2020
• Study Start: September 1, 2020
• Primary Completion: May 28, 2021
• Study Completion: May 28, 2021
• Last Updated: February 12, 2025
• Results First Posted: February 12, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)