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

NCT ID: NCT05844930

Last Updated: 2025-07-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-03
• Study Completion Date: 2025-02-04

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).

Conditions

Adhesive Capsulitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Intra-articular Injection of Corticosteroid Plus Lidocaine

Participants will receive a corticosteroid injection consisting of Triamcinolone 20 mg (1cc) with Lidocaine 10 mg/ml (5 cc).

Group Type: ACTIVE_COMPARATOR

Corticosteroid

Intervention Type: DRUG

Triamcinolone 20 mg (1cc)

Lidocaine

Intervention Type: DRUG

Lidocaine 10 mg/mL (5cc)

Intra-articular Injection of ActiveMatrix Plus Lidocaine

Participants will receive an injection consisting of ActiveMatrix (1cc; Skye Biologics, Inc.) with Lidocaine 10 mg/ml (5cc).

Group Type: EXPERIMENTAL

ActiveMatrix

Intervention Type: OTHER

1cc ActiveMatrix (Skye Biologics, Inc.)

Lidocaine

Intervention Type: DRUG

Lidocaine 10 mg/mL (5cc)

Interventions

Corticosteroid

Triamcinolone 20 mg (1cc)

Intervention Type: DRUG

ActiveMatrix

1cc ActiveMatrix (Skye Biologics, Inc.)

Intervention Type: OTHER

Lidocaine

Lidocaine 10 mg/mL (5cc)

Intervention Type: DRUG

Other Intervention Names

Triamcinolone; Human Placental Connective Tissue-Derived Allograft

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Skye Biologics, Inc.

INDUSTRY

Sponsor Role: collaborator

The University of Texas Health Science Center, Houston

OTHER

Sponsor Role: lead

Responsible Party

Eric F Berkman

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Eric F Berkman, MD

Role: PRINCIPAL_INVESTIGATOR

The University of Texas Health Science Center, Houston

Locations

The University of Texas Health Science Center at Houston

Houston, Texas, United States

Countries

United States

Other Identifiers

HSC-MS-21-0706

Identifier Type: -

Identifier Source: org_study_id