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

February 19, 2026 updated by: Eric F Berkman, The University of Texas Health Science Center, Houston

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

56

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • The University of Texas Health Science Center at Houston

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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).
Drug: Corticosteroid
Triamcinolone 20 mg (1cc)
Other Names:
  • Triamcinolone
Drug: Lidocaine
Lidocaine 10 mg/mL (5cc)
Experimental: 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).
Drug: Lidocaine
Lidocaine 10 mg/mL (5cc)
Other: ActiveMatrix
1cc ActiveMatrix (Skye Biologics, Inc.)
Other Names:
  • Human Placental Connective Tissue-Derived Allograft

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)
Time Frame: Baseline, Week 4
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)
Time Frame: Baseline, Week 12
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)
Time Frame: Baseline, week 24
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Pain Intensity as Assessed by the Visual Analog Scale (VAS)
Time Frame: Baseline, week 4
Visual Analog Scale (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. The change in pain intensity will be reported as [(VAS at week 4) - (VAS at baseline)] - a negative value indicates a decrease in pain intensity.
Baseline, week 4
Change in Pain Intensity as Assessed by the Visual Analog Scale (VAS)
Time Frame: Baseline, week 12
Visual Analog Scale (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. The change in pain intensity will be reported as [(VAS at week 12) - (VAS at baseline)] - a negative value indicates a decrease in pain intensity.
Baseline, week 12
Change in Pain Intensity as Assessed by the Visual Analog Scale (VAS)
Time Frame: Baseline, week 24
Visual Analog Scale (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. The change in pain intensity will be reported as [(VAS at 6 months) - (VAS at baseline)] - a negative value indicates a decrease in pain intensity.
Baseline, week 24
Change in Shoulder Function as Assessed by the American Shoulder and Elbow Surgeons (ASES) Score
Time Frame: Baseline, Week 4
The American shoulder and elbow surgeons (ASES) score assess shoulder function. ASES Score ranges from 0 to 100, with a score of 0 indicating a worse shoulder condition and a score of 100 indicating a better shoulder condition. The change in score is reported as [(ASES score at week 4) - (ASES score at baseline)] - a positive value indicates an improvement in shoulder function over time.
Baseline, Week 4
Change in Shoulder Function as Assessed by the American Shoulder and Elbow Surgeons (ASES) Score
Time Frame: Baseline, Week 12
The American shoulder and elbow surgeons (ASES) score assess shoulder function. ASES Score ranges from 0 to 100, with a score of 0 indicating a worse shoulder condition and a score of 100 indicating a better shoulder condition. The change in score is reported as [(ASES score at week 12) - (ASES score at baseline)] - a positive value indicates an improvement in shoulder function over time.
Baseline, Week 12
Change in American Shoulder and Elbow Surgeons (ASES) Score
Time Frame: Baseline, Week 24
The American shoulder and elbow surgeons (ASES) score assess shoulder function. ASES Score ranges from 0 to 100, with a score of 0 indicating a worse shoulder condition and a score of 100 indicating a better shoulder condition. The change in score is reported as [(ASES score at week 24) - (ASES score at baseline)] - a positive value indicates an improvement in shoulder function over time
Baseline, Week 24
Change in Range of Motion as Assessed by the Passive Range of Motion (PROM) Assessment Using a Goniometer (Abduction Internal Rotation)
Time Frame: Baseline, Week 4
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. Change from baseline will be calculated, with a positive values indicating improved range of motion.
Baseline, Week 4
Change in Range of Motion as Assessed by the Passive Range of Motion (PROM) Assessment Using a Goniometer (Abduction Internal Rotation)
Time Frame: Baseline, Week 12
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. Change from baseline will be calculated, with a positive values indicating improved range of motion.
Baseline, Week 12
Change in Range of Motion as Assessed by the Passive Range of Motion (PROM) Assessment Using a Goniometer (Abduction Internal Rotation)
Time Frame: Baseline, Week 24
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. Change from baseline will be calculated, with a positive values indicating improved range of motion.
Baseline, Week 24
Change in Range of Motion as Assessed by the Passive Range of Motion (PROM) Assessment Using a Goniometer (Abduction External Rotation)
Time Frame: Baseline, Week 4
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. Change from baseline will be calculated, with a positive values indicating improved range of motion.
Baseline, Week 4
Change in Range of Motion as Assessed by the Passive Range of Motion (PROM) Assessment Using a Goniometer (Abduction External Rotation)
Time Frame: Baseline, Week 12
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. Change from baseline will be calculated, with a positive values indicating improved range of motion.
Baseline, Week 12
Change in Range of Motion as Assessed by the Passive Range of Motion (PROM) Assessment Using a Goniometer (Abduction External Rotation)
Time Frame: Baseline, Week 24
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. Change from baseline will be calculated, with a positive values indicating improved range of motion.
Baseline, Week 24
Change in Range of Motion as Assessed by the Passive Range of Motion (PROM) Assessment Using a Goniometer (Forward Elevation)
Time Frame: Baseline, Week 4
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. Change from baseline will be calculated, with a positive values indicating improved range of motion.
Baseline, Week 4
Change in Range of Motion as Assessed by the Passive Range of Motion (PROM) Assessment Using a Goniometer (Forward Elevation)
Time Frame: Baseline, Week 12
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. Change from baseline will be calculated, with a positive values indicating improved range of motion.
Baseline, Week 12
Change in Range of Motion as Assessed by the Passive Range of Motion (PROM) Assessment Using a Goniometer (Forward Elevation)
Time Frame: Baseline, Week 24
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. Change from baseline will be calculated, with a positive values indicating improved range of motion.
Baseline, Week 24
Change in Range of Motion as Assessed by the Passive Range of Motion (PROM) Assessment Using a Goniometer (Abduction)
Time Frame: Baseline, Week 4
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. Change from baseline will be calculated, with a positive values indicating improved range of motion.
Baseline, Week 4
Change in Range of Motion as Assessed by the Passive Range of Motion (PROM) Assessment Using a Goniometer (Abduction)
Time Frame: Baseline, Week 12
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. Change from baseline will be calculated, with a positive values indicating improved range of motion.
Baseline, Week 12
Change in Range of Motion as Assessed by the Passive Range of Motion (PROM) Assessment Using a Goniometer (Abduction)
Time Frame: Baseline, Week 24
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. Change from baseline will be calculated, with a positive values indicating improved range of motion.
Baseline, Week 24
Change in Range of Motion as Assessed by the Passive Range of Motion (PROM) Assessment Using a Goniometer (External Rotation)
Time Frame: Baseline, Week 4
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. Change from baseline will be calculated, with a positive values indicating improved range of motion.
Baseline, Week 4
Change in Range of Motion as Assessed by the Passive Range of Motion (PROM) Assessment Using a Goniometer (External Rotation)
Time Frame: Baseline, Week 12
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. Change from baseline will be calculated, with a positive values indicating improved range of motion.
Baseline, Week 12
Change in Range of Motion as Assessed by the Passive Range of Motion (PROM) Assessment Using a Goniometer (External Rotation)
Time Frame: Baseline, Week 24
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. Change from baseline will be calculated, with a positive values indicating improved range of motion.
Baseline, Week 24
Change in Range of Motion as Assessed by the Passive Range of Motion (PROM) Assessment Using a Goniometer (Neutral Internal Rotation)
Time Frame: Baseline, Week 4
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. Change from baseline will be calculated, with a positive values indicating improved range of motion.
Baseline, Week 4
Change in Range of Motion as Assessed by the Passive Range of Motion (PROM) Assessment Using a Goniometer (Neutral Internal Rotation)
Time Frame: Baseline, Week 12
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. Change from baseline will be calculated, with a positive values indicating improved range of motion.
Baseline, Week 12
Change in Range of Motion as Assessed by the Passive Range of Motion (PROM) Assessment Using a Goniometer (Neutral Internal Rotation)
Time Frame: Baseline, Week 24
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. Change from baseline will be calculated, with a positive values indicating improved range of motion.
Baseline, Week 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Texas Health Science Center, Houston

Collaborators

Skye Biologics, Inc.

Investigators

  • Principal Investigator: Eric F Berkman, MD, The University of Texas Health Science Center, Houston

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 3, 2023

Primary Completion (Actual)

February 4, 2025

Study Completion (Actual)

February 4, 2025

Study Registration Dates

First Submitted

April 21, 2023

First Submitted That Met QC Criteria

April 21, 2023

First Posted (Actual)

May 6, 2023

Study Record Updates

Last Update Posted (Actual)

March 5, 2026

Last Update Submitted That Met QC Criteria

February 19, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HSC-MS-21-0706

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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