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

NCT05844930 | Completed Phase 4 Results FDA Drug

• 1 other identifier: HSC-MS-21-0706
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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

Keywords

Frozen Shoulder; musculoskeletal injuries

Outcome Measures

Primary Outcomes (3)

• 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. The change in score is reported as \[(SPADI at Week 4) - (SPADI at baseline)\] -- a negative value indicates pain and disability decreased over time.

  Baseline, Week 4

• 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. The change in score is reported as \[(SPADI at Week 12) - (SPADI at baseline)\] -- a negative value indicates pain and disability decreased over time.

  Baseline, Week 12

• 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. The change in score is reported as \[(SPADI at 6 months) - (SPADI at baseline)\] -- a negative value indicates pain and disability decreased over time.

  Baseline, week 24

Secondary Outcomes (24)

• Change in Pain Intensity as Assessed by the Visual Analog Scale (VAS)

  Baseline, week 4

• Change in Pain Intensity as Assessed by the Visual Analog Scale (VAS)

  Baseline, week 12

• Change in Pain Intensity as Assessed by the Visual Analog Scale (VAS)

  Baseline, week 24

• Change in Shoulder Function as Assessed by the American Shoulder and Elbow Surgeons (ASES) Score

  Baseline, Week 4

• Change in Shoulder Function as Assessed by the American Shoulder and Elbow Surgeons (ASES) Score

  Baseline, Week 12

Study Arms (2)

Intra-articular Injection of Corticosteroid Plus Lidocaine

ACTIVE COMPARATOR

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

Drug: Corticosteroid; Drug: Lidocaine

Intra-articular Injection of ActiveMatrix Plus Lidocaine

EXPERIMENTAL

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

Other: ActiveMatrix; Drug: Lidocaine

Interventions

Corticosteroid DRUG

Triamcinolone 20 mg (1cc)

Also known as: Triamcinolone

Intra-articular Injection of Corticosteroid Plus Lidocaine

ActiveMatrix OTHER

1cc ActiveMatrix (Skye Biologics, Inc.)

Also known as: Human Placental Connective Tissue-Derived Allograft

Intra-articular Injection of ActiveMatrix Plus Lidocaine

Lidocaine DRUG

Lidocaine 10 mg/mL (5cc)

Intra-articular Injection of ActiveMatrix Plus Lidocaine; Intra-articular Injection of Corticosteroid Plus Lidocaine

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead
• Skye Biologics, Inc.: collaborator

Study Sites (1)

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Bursitis

Interventions

Adrenal Cortex Hormones; Triamcinolone; Lidocaine

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Results Point of Contact

• Title: Eric F Berkman, MD
• Organization: The University of Texas Health Science Center at Houston

Eric.F.Berkman@uth.tmc.edu

713-314-4112

Study Officials

• Eric F Berkman, MD

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: April 21, 2023
• First Posted: May 6, 2023
• Study Start: January 3, 2023
• Primary Completion: February 4, 2025
• Study Completion: February 4, 2025
• Last Updated: March 5, 2026
• Results First Posted: February 18, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)