Clinical Study for the Treatment of Adhesive Capsulitis of the Shoulder (AC)
Adhesive Capsulitis, Frozen Shoulder
About this trial
This is an interventional treatment trial for Adhesive Capsulitis focused on measuring Adhesive Capsulitis, Frozen Shoulder, Shoulder Range of Motion limitation, Shoulder Pain
Eligibility Criteria
Inclusion Criteria:
- Unilateral idiopathic adhesive capsulitis of one shoulder for at least 3 months but not more than 12 months (Frozen Stage)
- Normal range of motion in the contralateral shoulder
Restricted active range of motion (AROM) in the affected shoulder defined as: a deficit of at least 60 degrees in total AROM in the affected shoulder as compared with the total AROM in the contralateral shoulder and a deficit of at least 30 degrees in AROM in at least one of the following planes as compared with the contralateral shoulder:
- Forward flexion
- Abduction
- External rotation with the elbow up to 90 degrees abduction
- Internal rotation with the elbow up to 90 degrees abduction
Exclusion Criteria:
Has received treatment for adhesive capsulitis or is planning to receive treatment for adhesive capsulitis at any time during the study including but not limited to:
- physical therapy or acupuncture within 2 weeks before the first injection of study drug
- intra-articular or intrabursal injection(s) of lidocaine; suprascapular nerve blocks; corticosteroids, electroanalgesic and/or thermoanalgesic modalities within 1 month before the screening visit
- intra-articular or intrabursal injection(s) of sodium hyaluronate and/or glenohumeral distension arthrography within 3 months before the screening visit
- surgical intervention (including shoulder manipulation under anesthesia) at any time
Has any of the following conditions, as determined by investigator to be potentially confounding to the evaluation of safety and efficacy:
- Adhesive capsulitis as a result of traumatic injury (ie, direct injury to the shoulder such as fracture of the humerus or clavicle immediately preceding the onset of this episode of adhesive capsulitis). Traumatic events in the past that are not temporally related to the onset of this episode of adhesive capsulitis would not necessarily exclude a subject from participating in the study.
- Active subacromial impingement in the affected shoulder
- Calcified tendonitis in the affected shoulder
- Glenohumeral joint arthritis in the affected shoulder
- Arthrosis of the affected shoulder
- Chondrolysis of the affected shoulder
- Subscapularis tendon rupture of the affected shoulder
- Other rotator cuff injuries of the affected shoulder
- Uncontrolled hypertension
- Uncontrolled diabetes
- Uncontrolled thyroid disease
- History of thrombosis or post-thrombosis syndrome
- Physical impairment that would preclude performing the protocol defined exercises
- Active infection in area to be treated
- Clinically significant neurological disease
- Bleeding disorder
- Chronic use of anticoagulation medications and the subject cannot be cleared medically to stop taking medication for 7 days prior to each injection. Less than or equal to 150 mg aspirin is allowed during the study.
- Known active hepatitis A, B, or C
- Other significant medical condition (eg, morbid obesity, cervical disc disease), which in the investigator's opinion would make the subject unsuitable for enrollment in the study
- Has received oral or intravenous steroids for any reason within 3 weeks before the screening visit
- Has received an investigational drug or treatment within 30 days before the first dose of study drug.
- Has a known allergy to collagenase or any other excipient of AA4500 or any other procedural medication.
- Has, at any time, received collagenase for the treatment of adhesive capsulitis.
- Is unable to undergo an x-ray or MRI (contraindication) evaluation of the affected shoulder.
- Is planning to be treated with commercial XIAFLEX at any time during the study.
Sites / Locations
- Alabama Orthopaedic Center-Research
- Coastal Clinical Research
- Arizona Research Center, Inc.
- Advance Med Clinical Research
- Triwest Research Associates
- Core Orthopedic Medical Center
- Temecula Rheumatology & Internal Medicine
- Clearview Medical Research
- Colorado Orthopedic Consultants, PC
- Florida Research Associates
- Shrock Orthopedic Research, LLC
- Jewett Orthopedic Clinic
- Clinical Research of West Florida
- Non-Surgical Orthopedics, P.C. / Georgia Institute for Clinical Research, LLC
- Injury Care Medical Center
- Rockford Orthopedic Associates
- Rockford Orthopedics Associates
- Indiana Hand to Shoulder Center
- PRN of Kansas
- Central Kentucky Research Associates
- Bone and Joint Clinic
- MedPharmics, LLC
- Arthritis and Rheumatism Associates, PC
- Great Falls Clinic
- Nevada Orthopedic & Spine Center
- Stony Brook University Medical Center (SUNY)
- Triangle Orthopedic Associates, PA
- Wake Research Associates
- The Neuromusculoskeletal Center of the Cascades d.b.a. The Center
- Blair Orthopedic Associates, Inc.
- University of Pennsylvania Penn Orthopaedics
- Texas Orthopedic Specialist
- Centex Studies
- Commonwealth Orthopaedics & Rehabilitation
- Danville Orthopedic Clinic, Inc.
- Sports Medicine Professionals
- Hunter Clinical Research
- Royal Prince Alfred
- St George Hospital
- Peninsula Private Hospital
- QPharm
- Menzies Research Institute
- Emeritus Research
- Epworth Hospital
- Repatriation Hospital
- Hand and Upper Limb Centre
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Collagenase Clostridium Histolyticum
Placebo
Up to 3 injections of .58 mg/1 mL of collagenase clostridium histolyticum (CCH), minimum of 21 days apart and home shoulder exercise.
Up to 3 1-mL injections of placebo, minimum of 21 days apart and home shoulder exercise.