Comparative Effectiveness of Particulate Versus Nonparticulate Steroid Injections for Musculoskeletal Conditions

Sponsor

Stanford University (Other)

Overall Status

Recruiting

CT.gov ID

NCT04278833

Collaborator

(none)

198

Enrollment

Location

Arms

Anticipated Duration (Months)

7.3

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Osteoarthritis Tendinopathy Impingement Shoulder	Drug: Triamcinolone or Betamethasone Drug: Dexamethasone	Phase 4

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 Design

Study Type:

Interventional

Anticipated Enrollment :

198 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention 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.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:

Single (Participant)

Masking Description:

Participants will be blinded to the type of corticosteroid (particulate or non-particulate) that they receive.

Primary Purpose:

Treatment

Official Title:

Comparative Effectiveness of Particulate Versus Nonparticulate Corticosteroid Injections for the Treatment of Musculoskeletal Conditions

Actual Study Start Date :

Sep 1, 2020

Anticipated Primary Completion Date :

Dec 1, 2022

Anticipated Study Completion Date :

Dec 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Other: Particulate Corticosteroid Injection 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 Image guided intra-articular, peri-tendinous, or intra-bursal corticosteroid injection Other Names: Particulate Steroid
Other: Non-particulate Corticosteroid Injection 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 Image guided intra-articular, peri-tendinous, or intra-bursal corticosteroid injection Other Names: Non-Particulate Steroid

Arm

Intervention/Treatment

Other: Particulate Corticosteroid Injection

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

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

Other Names:

Particulate Steroid

Other: Non-particulate Corticosteroid Injection

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

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

Other Names:

Non-Particulate Steroid

Outcome Measures

Primary Outcome Measures

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

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.
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.
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.
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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