Clinical trial NCT05844930: A Study to Determine the Safety and Effectiveness of a Connective Tissue Allograft (ActiveMatrix) Verses Standard of Care in Adhesive Capsulitis of the 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Adhesive Capsulitis
Keywords: Frozen Shoulder
musculoskeletal injuries
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
Collaborators: name: Skye Biologics, Inc.
First posted: 2023-05-06
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


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

Primary outcomes:
measure: Change in Pain as assessed by the Shoulder Pain and Disability Index (SPADI)
timeFrame: Baseline
measure: Change in Pain as assessed by the Shoulder Pain and Disability Index (SPADI)
timeFrame: 4 weeks following injection
measure: Change in Pain as assessed by the Shoulder Pain and Disability Index (SPADI)
timeFrame: 12 weeks following injection
measure: Change in Pain as assessed by the Shoulder Pain and Disability Index (SPADI)
timeFrame: 6 months following injection
Secondary outcomes:
measure: Change in pain intensity as assessed by the Visual Analog Scale (VAS)
timeFrame: Baseline
measure: Change in pain intensity as assessed by the Visual Analog Scale (VAS)
timeFrame: 4 weeks following injection
measure: Change in pain intensity as assessed by the Visual Analog Scale (VAS)
timeFrame: 12 weeks following injection
measure: Change in pain intensity as assessed by the Visual Analog Scale (VAS)
timeFrame: 6 months following injection
measure: Change in range of motion as assessed by the Passive Range of Motion (PROM) assessment using a goniometer (left side)
timeFrame: Baseline
measure: Change in range of motion as assessed by the Passive Range of Motion (PROM) assessment using a goniometer (left side)
timeFrame: 4 weeks following injection
measure: Change in range of motion as assessed by the Passive Range of Motion (PROM) assessment using a goniometer (left side)
timeFrame: 12 weeks following injection
measure: Change in range of motion as assessed by the Passive Range of Motion (PROM) assessment using a goniometer (left side)
timeFrame: 6 months following injection
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Eric F Berkman, MD
role: PRINCIPAL_INVESTIGATOR
References: