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Comparative Effectiveness of Particulate Versus Nonparticulate Steroid Injections for Musculoskeletal Conditions

Primary Purpose

Osteoarthritis, Tendinopathy, Impingement Shoulder

Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Triamcinolone or Betamethasone
Dexamethasone
Sponsored by
Stanford University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis focused on measuring corticosteroid injection, particulate steroid, non-particulate steroid

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

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

Sites / Locations

  • Stanford UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Particulate Corticosteroid Injection

Non-particulate Corticosteroid Injection

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index
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)
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.
American Shoulder and Elbow Surgeons (ASES) Standardized Shoulder Assessment Form
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.
Number of repeat corticosteroid injections
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.
Conversion to surgery
Percent of participants who were referred for surgical intervention on the specific anatomical site during the study follow up period.

Full Information

First Posted
February 13, 2020
Last Updated
March 17, 2023
Sponsor
Stanford University
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1. Study Identification

Unique Protocol Identification Number
NCT04278833
Brief Title
Comparative Effectiveness of Particulate Versus Nonparticulate Steroid Injections for Musculoskeletal Conditions
Official Title
Comparative Effectiveness of Particulate Versus Nonparticulate Corticosteroid Injections for the Treatment of Musculoskeletal Conditions
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2020 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This aims of this study are: 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Tendinopathy, Impingement Shoulder
Keywords
corticosteroid injection, particulate steroid, non-particulate steroid

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
Participant
Masking Description
Participants will be blinded to the type of corticosteroid (particulate or non-particulate) that they receive.
Allocation
Randomized
Enrollment
198 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Particulate Corticosteroid Injection
Arm Type
Other
Arm Description
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.
Arm Title
Non-particulate Corticosteroid Injection
Arm Type
Other
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Triamcinolone or Betamethasone
Other Intervention Name(s)
Particulate Steroid
Intervention Description
Image guided intra-articular, peri-tendinous, or intra-bursal corticosteroid injection
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Other Intervention Name(s)
Non-Particulate Steroid
Intervention Description
Image guided intra-articular, peri-tendinous, or intra-bursal corticosteroid injection
Primary Outcome Measure Information:
Title
Mean change in average pain from baseline
Description
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.
Time Frame
Baseline and at 2 weeks, 3 months, and 6 months post intervention
Secondary Outcome Measure Information:
Title
Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index
Description
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.
Time Frame
Baseline and at 2 weeks, 3 months, and 6 months post intervention
Title
Quick Disabilities of Arm, Shoulder, and Hand (QDASH)
Description
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.
Time Frame
Baseline and at 2 weeks, 3 months, and 6 months post intervention
Title
American Shoulder and Elbow Surgeons (ASES) Standardized Shoulder Assessment Form
Description
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.
Time Frame
Baseline and at 2 weeks, 3 months, and 6 months post intervention
Title
Number of repeat corticosteroid injections
Description
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.
Time Frame
6 months post initial intervention
Title
Conversion to surgery
Description
Percent of participants who were referred for surgical intervention on the specific anatomical site during the study follow up period.
Time Frame
6 months post initial intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eugene Roh, MD
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University
City
Redwood City
State/Province
California
ZIP/Postal Code
94063
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Agnes Martinez Ith
Phone
650-721-7600
Email
mith@stanford.edu

12. IPD Sharing Statement

Plan to Share IPD
No
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Comparative Effectiveness of Particulate Versus Nonparticulate Steroid Injections for Musculoskeletal Conditions

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