COMPLETED

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

Conditions

Adhesive Capsulitis Frozen Shoulder musculoskeletal injuries

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

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

Quick Facts

Study Start:2023-01-03

Study Completion:2025-02-04

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT05844930

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.

Ages Eligible for Study:18 Years to 75 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	* 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

Inclusion Criteria

Exclusion 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.

* 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

Contacts and Locations

Principal Investigator

Eric F Berkman, MD

PRINCIPAL_INVESTIGATOR

The University of Texas Health Science Center, Houston

Study Locations (Sites)

The University of Texas Health Science Center at Houston

Houston, Texas, 77030

United States

Collaborators and Investigators

Sponsor: The University of Texas Health Science Center, Houston

Eric F Berkman, MD, PRINCIPAL_INVESTIGATOR, 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 Registration Dates

Study Start Date2023-01-03

Study Completion Date2025-02-04

Study Record Updates

Study Start Date2023-01-03

Study Completion Date2025-02-04

Terms related to this study

Keywords Provided by Researchers

Frozen Shoulder
musculoskeletal injuries

Additional Relevant MeSH Terms

Adhesive Capsulitis