This study is intended to test a new treatment for a condition called adhesive capsulitis, also known as frozen shoulder. The treatment being tested is called bevacizumab. Participants will receive a single dose of bevacizumab (50mg, 100mg, 150mg, or 200mg) via injection into their shoulder joint. After the injection, participants will return to site 6 times over the course of a year for safety assessments, questionnaires to track pain levels, and range of movement tests conducted by a physiotherapist.
The main goal of this study is to:
1. Evaluate the safety and effectiveness of bevacizumab when it is injected into the frozen shoulder joint. 2. Determine the maximum dose of bevacizumab that can be given without side effects.
This is an investigator initiated clinical trial sponsored by Macquarie University. There will be a maximum of 28 participants enrolled and the only site involved in recruitment is Macquarie University.
Progressive pain and stiffness for a period greater than 2 months but less than 6 months; and,
Either thickening or signal hyperintensity associated with coracohumeral ligament, axillary pouch, or rotator interval joint capsule OR obliteration of the subcoracoid fat triangle as confirmed by radiological examination (magnetic resonance imaging); and,
Normal x-ray of the shoulder with no evidence of glenohumeral joint degenerative changes or sequelae of previous trauma.
Female participants must not be pregnant or breastfeeding AND are either abstinent from heterosexual intercourse as their preferred usual lifestyle OR engage in an adequate method of contraception (i.e., the oral contraceptive pill, intrauterine device, or other)
Intra-articular or intrabursal injection(s) of lidocaine, suprascapular nerve blocks; corticosteroids, electroanalgesic and/or thermoanalgesic modalities
Intra-articular or intrabursal injection(s) of sodium hyaluronate and/or glenohumeral distension arthrography
Surgical intervention
Single group
Bevacizumab
Drugintra-articular bevacizumab
Evaluate the safety of bevacizumab over a 52-week period in participants with adhesive capsulitis
* Incidence of adverse events (including medically significant changes in physical assessments, laboratory assessments, vital signs, and electrocardiogram), and serious adverse events, at 7 days (V3), 14 days (V4), 28 days (V5), 84 days (V6), 168 days (V7), and 364 days (V8) * Incidence of adverse events and serious adverse events at 3 days (V2)
Determine the maximum tolerated dose of intra-articular bevacizumab at 1 week (V3) per cohort
Maximum tolerated dose as defined as the highest dose where 0 out of 3 participants or no more than 1 out of 6 participants experienced any dose-limiting toxicity (defined as a grade 3 or higher adverse event as per Common Terminology Criteria for Adverse Events version 5.0
Evaluate the efficacy of bevacizumab over a 52-week period in participants with adhesive capsulitis
Change in passive global range of motion loss against contralateral shoulder at baseline (V1) versus 14 days (V4), 28 days (V5), 84 days (V6), 168 days (V7), and 364 days (V8)
Evaluate the efficacy of bevacizumab over a 52-week period in participants with adhesive capsulitis
Change in pain levels (assessed by a visual analogue scale: 0 to 100, higher score indicating worse outcome) at baseline (V1) versus 14 days (V4), 28 days (V5), 84 days (V6), 168 days (V7), and 364 days (V8).
Evaluate the efficacy of bevacizumab over a 52-week period in participants with adhesive capsulitis
Change in Shoulder Pain and Disability Index assessment (Roach, 1991) at baseline (V1) versus 14 days (V4), 28 days (V5), 84 days (V6), 168 days (V7), and 364 days (V8)
Evaluate the efficacy of bevacizumab over a 52-week period in participants with adhesive capsulitis
Change in Quick Disabilities of the Arm, Shoulder and Hand assessment (Work and Health, 2006) at baseline (V1) versus 14 days (V4), 28 days (V5), 84 days (V6), 168 days (V7), and 364 days (V8)
Evaluate the safety of bevacizumab over a 52-week period in participants with adhesive capsulitis
Incidence of study discontinuations and withdrawals due to adverse events at 3 days (V2), 7 days (V3), 14 days (V4), 28 days (V5), 84 days (V6), 168 days (V7), and 364 days (V8)
Evaluate the efficacy of bevacizumab over a 24-week period in participants with adhesive capsulitis
Change in passive global range of motion loss against contralateral shoulder at baseline (V1) versus 84 days (V6) and 168 days (V7)
Evaluate the efficacy of bevacizumab over a 24-week period in participants with adhesive capsulitis
Change in Shoulder Pain and Disability Index assessment (Roach, 1991) at baseline (V1) versus 84 days (V6) and 168 days (V7)
Evaluate the efficacy of bevacizumab over a 24-week period in participants with adhesive capsulitis
Change in Quick Disabilities of the Arm, Shoulder and Hand assessment (Work and Health, 2006) at baseline (V1) versus 84 days (V6) and 168 days (V7)
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