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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
165
Image guided intra-articular, peri-tendinous, or intra-bursal corticosteroid injection
Image guided intra-articular, peri-tendinous, or intra-bursal corticosteroid injection
Stanford University
Redwood City, California, United States
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.
Time frame: 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.
Time frame: Baseline and at 2 weeks, 3 months, and 6 months post intervention
Change in 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.
Time frame: Baseline and at 2 weeks, 3 months, and 6 months post intervention
Change in 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.
Time frame: Baseline and at 2 weeks, 3 months, and 6 months post intervention
Change in 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.
Time frame: Baseline and at 2 weeks, 3 months, and 6 months post intervention
Number of Participants With 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.
Time frame: 6 months post initial intervention
Number of Participants Referred for Surgical Intervention (Conversion to Surgery)
Number (%) 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
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