Phase 2 N=322 Clinical Study for the Treatment of Adhesive Capsulitis of the Shoulder
Adhesive Capsulitis · Frozen Shoulder
Primary: Change From Baseline to Day 95 in Active Forward Flexion — 41.0; 35.9 degrees
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Phase 2 N=50 AA4500 for the Treatment of Adhesive Capsulitis of the Shoulder
Adhesive Capsulitis · Frozen Shoulder
Primary: Change From Baseline to Day 92 in Active Forward Flexion — 22.9; 37.5; 42.9; 23.8 degrees
Phase 4 N=1 Intra-articular Doxycycline: A Novel Treatment of Adhesive Capsulitis
Adhesive Capsulitis · Adhesive Capsulitis of Unspecified Shoulder · Frozen Shoulder
Primary: Change in American Shoulder and Elbow Score (ASES)
Phase 3 N=9 The Anti-Freaze-F Study- "Anti-TNF for Treatment of Frozen Shoulder - a Feasibility Study"
Frozen Shoulder
Primary: Number of Participants Eligible With Pain Predominant Frozen Shoulder — 39 Participants
Phase 4 N=52 A Study to Determine the Safety and Effectiveness of a Connective Tissue Allograft (ActiveMatrix) Verses Standard of Care in Adhesive Capsulitis of the Shoulder
Adhesive Capsulitis
Primary: Change in Pain as Assessed by the Shoulder Pain and Disability Index (SPADI) — -37.8; -9.5 score on a scale
N/A N=46 Percutaneous Interruption of the Coracohumeral Ligament for the Treatment of Frozen Shoulder
Adhesive Capsulitis
Primary: Comparison of Range of Motion of the Shoulder — 61; 49; 80; 64 degrees
Phase 2 N=198 Safety and Efficacy of EN3835 in Participants With Frozen Shoulder
Adhesive Capsulitis · Frozen Shoulder
Primary: Change From Baseline in the Adapted American Shoulder and Elbow Surgeons Shoulder Assessment Form (ASES) Composite Score for the Affected Shoulder at Day 95 — 41.35…
N/A N=54 Should the Joint Capsule of the Painful Stiff Shoulder be Ruptured During Intra-articular Hydraulic Distension?
Adhesive Capsulitis
Primary: Range of Motion (ROM) of the Glenohumeral Joint — 261.95; 241.84 degree
Phase 2 N=9 Glenohumeral Cortisone Injection
Humeral Fractures
Primary: American Shoulder Elbow Society Score — 46; 87 score on a scale
N/A N=59 Changes in Subjects With Posterior Capsule Tightness
Shoulder Pain
Primary: Scapular Kinematics at 4weeks (Pre and Post Treatment) — 34.58; 36.00; 34.76; 35.72 degrees
Phase 2 N=140 Repurposing Anti-TNF for Treating Dupuytren's Disease
Dupuytren's Disease
Primary: Early Disease: Nodule Hardness at 12 Months — 58.1; 61.2 Durometer Arbitrary Units (AU)
N/A N=60 Evaluation of High-Purity Type I Collagen Biologic Wrap to Improve Function After Extensor Tendon Repair of the Hand
Injury of Extensor Tendon of Hand · Tendon Adhesions
Primary: Total Active Motion (TAM) of Involved Finger(s) — 232.4; 201.3 degrees
N/A N=50 Effectiveness of Diacutaneous Fibrolysis in Painful Shoulder
Shoulder Pain
Primary: Change in Active Flexion Movement After Intervention Minus Baseline — 9.48; -1.92 Sexagesimal Degrees — p=<0.01
Phase 3 N=308 AA4500 (XIAFLEX™, Proposed Name) in the Treatment of Dupuytren's Contracture
Dupuytren's Contracture
Primary: Clinical Success (Reduction in Contracture to 5° or Less) of the Primary Joint After the Last Injection — 64; 6.8 Percentage of Joints — p=<0.001
Phase 3 N=254 Treatment Of Dupuytren's Contracture With Collagenase Clostridium Histolyticum Injection (Xiapex)
Dupuytren's Contracture
Primary: Total Passive Extension Deficit (TPED) at Baseline for First Injection — 55.0 degrees
N/A N=49 Compression and Cold Therapy on the Post-Operative Shoulder
Postoperative Pain · Shoulder Pain
Primary: Patient Reported Pain on Day 0 — 30.2; 24.2 Visual Analog Score (0-100)
N/A N=116 Peripheral Nerve Stimulation(PNS) for Subacromial Impingement Syndrome(SIS)
Shoulder Pain · Shoulder Impingement Syndrome · Shoulder Tendinitis
Primary: Change in - Short Form (SF) Question 3 (BPI-SF3) — 6.90; 7.05; 3.58; 3.96 units on a scale
Phase 4 N=421 Pain Increases After Shoulder Injection
Shoulder Pain
Primary: Incidence of a Flare Reaction — 44; 8; 149; 191 Person-visits
Phase 4 N=5 MRI Results in Dupuytren's Contracture Before and After Injection With Xiaflex
Dupuytren's Disease
Primary: The Measured Change in Volume of the Cord by MRI Before and After XIAFLEX Injection and Manual Manipulation. — 482 mm^3 — p=<0.0013
Phase 3 N=40 Impact of TheraWorx Foam on Symptom Relief in Thumb Arthritis
Arthritis
Primary: Numeric Pain Rating Scale — 1.7; 2.4; 3.2 units on a scale — p=0.6
Phase 3 N=66 Non-US Study of AA4500 (XIAFLEX™, Proposed Name) in the Treatment of Advanced Dupuytren's Disease
Advanced Dupuytren's Disease
Primary: Reduction in Primary Joint Contracture to 5° or Less — 44.4; 4.8 Percentage of Joints — p=<.001
Phase 4 N=102 Exparel for Total Shoulder Arthroplasty
Total Shoulder Arthroplasty
Primary: Pain Score in the 24 Hours After Surgery — 0.76; 3.37 score on a scale
N/A N=78 Study of 25% Dextrose Injections in Shoulder Ligaments and Tendons to Promote Their Healing
Rotator Cuff Tendinitis
Primary: Visual Analog Pain Scale 0= no Pain 10 = Maximum Pain — 7.3; 6.9; 6.9 units on a scale
N/A N=35 IFC Therapy in Proximal Humerus Fractures
Interferential Current in Proximal Humerus Fractures
Primary: Constant-Murley Score — 57.0; 48.2; 69.0; 60.7 score on a scale
N/A N=24 Performance and Safety Evaluation of MD-Shoulder Collagen Medical Device in the Treatment of Rotator Cuff Syndrome
Rotator Cuff Tendinitis · Syndrome Rotator Cuff · Tendinopathy
Primary: Change From Baseline in Constant-Murley Score (CMS) at 3 Months — 10.03 units on a scale — p=0.001
N/A N=104 Physical Therapy Versus Steroid Injection for Shoulder Impingement Syndrome
Shoulder Impingement Syndrome
Primary: Shoulder Pain and Disability Index — 21.6; 23.1 units on a scale
N/A N=38 Efficacy of Capacitive-Resistive Therapy on the Treatment of Myofascial Pain
Myofascial Pain Syndrome of Neck
Primary: Visual Analog Scale (VAS) Score Change — 5.9; 5.1; 4.1; 2.3 score on a scale
N/A N=64 Corticosteroid Injection for Common Upper Extremity Problems
Lateral Elbow Pain
Primary: Disabilities of the Arm, Shoulder, and Hand (DASH) Questionnaire — 18; 13 units on a scale
Phase 4 N=70 Exparel for Postoperative Pain Management in Shoulder Surgery
Fracture of Shoulder and Upper Arm
Primary: Quality of Analgesia — 2.1; 2.6; 4.1; 4.0 score on a scale
N/A N=62 Cast Immobilization for Non-Displaced Scaphoid Fractures
Non-displaced Scaphoid Fractures
Primary: Extent of Union — 70; 85 percentage of union