Clinical trial NCT04278833: 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
Overall status: TERMINATED
Phase: PHASE4
Conditions: Osteoarthritis
Tendinopathy
Impingement Shoulder
Keywords: corticosteroid injection
particulate steroid
non-particulate steroid
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2020-02-20
Enrollment: 165
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Mean Change in Average Pain From Baseline
timeFrame: Baseline and at 2 weeks, 3 months, and 6 months post intervention
measure: Number of Participants With ≥50% Decrease in Pain From Baseline
timeFrame: Baseline and at 2 weeks, 3 months, and 6 months post intervention
Secondary outcomes:
measure: Change in Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index
timeFrame: Baseline and at 2 weeks, 3 months, and 6 months post intervention
measure: Change in Quick Disabilities of Arm, Shoulder, and Hand (QDASH)
timeFrame: Baseline and at 2 weeks, 3 months, and 6 months post intervention
measure: Change in American Shoulder and Elbow Surgeons (ASES) Standardized Shoulder Assessment Form
timeFrame: Baseline and at 2 weeks, 3 months, and 6 months post intervention
measure: Number of Participants With Repeat Corticosteroid Injections
timeFrame: 6 months post initial intervention
measure: Number of Participants Referred for Surgical Intervention (Conversion to Surgery)
timeFrame: 6 months post initial intervention
Other outcomes:
Locations:
city: Redwood City
country: United States
facility: Stanford University
state: California
Study officials:
affiliation: Stanford University
name: Eugene Roh, MD
role: PRINCIPAL_INVESTIGATOR
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