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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
56

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The University of Texas Health Science Center, Houston

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Skye Biologics, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 3, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 4, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 4, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 21, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 21, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 6, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 5, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 19, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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