A Study to Determine the Safety and Effectiveness of a Connective Tissue Allograft (ActiveMatrix) Verses Standard of Care in Adhesive Capsulitis of the Shoulder

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare ActiveMatrix® to standard of care corticosteroid injection in the treatment of adhesive capsulitis of the shoulder (frozen shoulder).

Official Title
-----------------
Double Blinded Prospective Pilot Study to Determine the Safety and Effectiveness of a Connective Tissue Allograft (ActiveMatrix) vs. Standard of Care in Adhesive Capsulitis of the Shoulder

Conditions
-----------------
Adhesive Capsulitis

Intervention / Treatment
-----------------
* Drug: Corticosteroid
* Other: ActiveMatrix
* Drug: Lidocaine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Provision of signed and dated informed consent form Stated willingness to comply with all study procedures and availability for the duration of the study Have a clinical diagnosis of adhesive capsulitis, defined as: i. pain along the C5 dermatome; and ii. limitations of passive range of motion of more than 20 degrees in the abduction internal rotation, neutral external rotation, forward elevation and abduction planes when compared to the contralateral shoulder Have no contraindications or allergies to the treatment administered Have experienced shoulder pain for more than 6 weeks and less than 1 year (to ensure the patient is in the freezing stage of adhesive capsulitis). Have current imaging studies (plain radiographs and MRI exams) of the shoulder to rule out other etiologic diagnoses. Exclusion Criteria: Any prior treatment for this episode of shoulder pain, such as prior intra-articular injection or prior physiotherapy Evidence, based on MRI or plain radiographs, of any pathology within the shoulder other than adhesive capsulitis (e.g., glenohumeral osteoarthritis, full thickness tears of the labrum or rotator cuff, tendinosis, calcific tendonitis) A history of significant trauma to the shoulder Poorly controlled diabetes mellitus, as defined by HbA1c > 7.5 mmol/L and glucose > 200 mg/dL. For diabetic participants HbA1c and glucose levels will be measured prior to intervention and documented for later analysis. For non-diabetic participants, previous labs will be utilized. All other medical diseases will be documented for later analysis. History of Cardiovascular Accident (CVA) such as stroke or Transient Ischemic Attack (TIA) Blood dyscrasias Use of any NSAIDs besides Tylenol. A letter will be sent to each participant's primary care physician(s) requesting that no additional pain medications be given for the duration of the study Prior shoulder surgery

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Intra-articular Injection of Corticosteroid Plus Lidocaine<br>Participants will receive a corticosteroid injection consisting of Triamcinolone 20 mg (1cc) with Lidocaine 10 mg/ml (5 cc). | Drug: Corticosteroid<br>* Triamcinolone 20 mg (1cc)<br>* Other names: Triamcinolone;Drug: Lidocaine<br>* Lidocaine 10 mg/mL (5cc)<br>|
| Experimental: Intra-articular Injection of ActiveMatrix Plus Lidocaine<br>Participants will receive an injection consisting of ActiveMatrix (1cc; Skye Biologics, Inc.) with Lidocaine 10 mg/ml (5cc). | Other: ActiveMatrix<br>* 1cc ActiveMatrix (Skye Biologics, Inc.)<br>* Other names: Human Placental Connective Tissue-Derived Allograft;Drug: Lidocaine<br>* Lidocaine 10 mg/mL (5cc)<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Pain as assessed by the Shoulder Pain and Disability Index (SPADI) | SPADI is a self-administered questionnaire that measures a combination of pain and functional disability. SPADI is scored from 0 to 100 with a high score representing more pain and disability. | Baseline | 
| Change in Pain as assessed by the Shoulder Pain and Disability Index (SPADI) | SPADI is a self-administered questionnaire that measures a combination of pain and functional disability. SPADI is scored from 0 to 100 with a high score representing more pain and disability. | 4 weeks following injection | 
| Change in Pain as assessed by the Shoulder Pain and Disability Index (SPADI) | SPADI is a self-administered questionnaire that measures a combination of pain and functional disability. SPADI is scored from 0 to 100 with a high score representing more pain and disability. | 12 weeks following injection | 
| Change in Pain as assessed by the Shoulder Pain and Disability Index (SPADI) | SPADI is a self-administered questionnaire that measures a combination of pain and functional disability. SPADI is scored from 0 to 100 with a high score representing more pain and disability. | 6 months following injection | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in pain intensity as assessed by the Visual Analog Scale (VAS) | VAS is scored on a 100mm horizontal line that represents pain intensity, from 0mm to 100mm, with a higher score corresponding to increased pain intensity. | Baseline | 
| Change in pain intensity as assessed by the Visual Analog Scale (VAS) | VAS is scored on a 100mm horizontal line that represents pain intensity, from 0mm to 100mm, with a higher score corresponding to increased pain intensity. | 4 weeks following injection | 
| Change in pain intensity as assessed by the Visual Analog Scale (VAS) | VAS is scored on a 100mm horizontal line that represents pain intensity, from 0mm to 100mm, with a higher score corresponding to increased pain intensity. | 12 weeks following injection | 
| Change in pain intensity as assessed by the Visual Analog Scale (VAS) | VAS is scored on a 100mm horizontal line that represents pain intensity, from 0mm to 100mm, with a higher score corresponding to increased pain intensity. | 6 months following injection | 
| Change in range of motion as assessed by the Passive Range of Motion (PROM) assessment using a goniometer (left side) | A goniometer will be used to measure range of motion during the PROM assessment. The goniometer measures the angle between the beginning position and the ending position of available motion, and the result is reported in degrees. | Baseline | 
| Change in range of motion as assessed by the Passive Range of Motion (PROM) assessment using a goniometer (left side) | A goniometer will be used to measure range of motion during the PROM assessment. The goniometer measures the angle between the beginning position and the ending position of available motion, and the result is reported in degrees. | 4 weeks following injection | 
| Change in range of motion as assessed by the Passive Range of Motion (PROM) assessment using a goniometer (left side) | A goniometer will be used to measure range of motion during the PROM assessment. The goniometer measures the angle between the beginning position and the ending position of available motion, and the result is reported in degrees. | 12 weeks following injection | 
| Change in range of motion as assessed by the Passive Range of Motion (PROM) assessment using a goniometer (left side) | A goniometer will be used to measure range of motion during the PROM assessment. The goniometer measures the angle between the beginning position and the ending position of available motion, and the result is reported in degrees. | 6 months following injection | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Frozen Shoulder, musculoskeletal injuries