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Tests treatment safety and results for Adhesive Capsulitis
Official title A Study to Determine the Safety and Efficacy of Bevacizumab Administered Via Injection Into the Shoulder Joint of Participants With Adhesive Capsulitis (Frozen Shoulder)
ClinicalTrials.gov ID: NCT06976671
What this study is testing
What is Bevacizumab?
Bevacizumab is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for adhesive capsulitis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- IC1. Over 18 years of age (inclusive) at the time of signing informed consent IC2. Clinical diagnosis of adhesive capsulitis which is defined as:
- 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...
- Normal x-ray of the shoulder with no evidence of glenohumeral joint degenerative changes or sequelae of previous trauma. IC3. Capable of giving...
- Female participants must not be pregnant or breastfeeding AND are either abstinent from heterosexual intercourse as their preferred usual lifestyle...
You likely can't join if
- EC1. History of previous surgery or treatment with corticosteroid prior to screening, platelet-rich plasma, or anti-VEGF injections in the...
- Intra-articular or intrabursal injection(s) of lidocaine, suprascapular nerve blocks; corticosteroids, electroanalgesic and/or thermoanalgesic...
- Intra-articular or intrabursal injection(s) of sodium hyaluronate and/or glenohumeral distension arthrography
- Surgical intervention EC10. Progressive pain and stiffness in the affected shoulder that is for a period less than 2 months or greater than 6 months...
See the full eligibility criteria
- IC1. Over 18 years of age (inclusive) at the time of signing informed consent IC2. Clinical diagnosis of adhesive capsulitis which is defined as:
- 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...
- Normal x-ray of the shoulder with no evidence of glenohumeral joint degenerative changes or sequelae of previous trauma. IC3. Capable of giving signed informed consent as described in Section 14 of the protocol which...
- 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...
- Male participants must refrain from donating sperm AND are either abstinent from heterosexual intercourse as their preferred usual lifestyle OR must agree to use an adequate method of contraception/barrier method (i.e...
- Female participants in a post-menopausal state (defined as not experiencing menses for 12 consecutive months without an alternative cause)
- Documented permanent sterilisation method (including, but not limited to, hysterectomy, bilateral salpingectomy, bilateral oophorectomy, and vasectomy)
- EC1. History of previous surgery or treatment with corticosteroid prior to screening, platelet-rich plasma, or anti-VEGF injections in the ipsilateral shoulder EC2. History of adhesive capsulitis in ipsilateral shoulder...
- 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 EC10. Progressive pain and stiffness in the affected shoulder that is for a period less than 2 months or greater than 6 months EC11. Hypersensitivity to the study intervention, including any...
The study team makes the final eligibility decision.
Where it's taking place
- North Ryde, New South Wales, Australia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include North Ryde, New South Wales, Australia. Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.