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

Study Purpose

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).

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years - 75 Years
Gender	All

More Inclusion & Exclusion 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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05844930
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 4
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	The University of Texas Health Science Center, Houston
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Eric F Berkman, MD
Principal Investigator Affiliation	The University of Texas Health Science Center, Houston
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Adhesive Capsulitis

Arms & Interventions

Arms

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).

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).

Interventions

Drug: - Corticosteroid

Triamcinolone 20 mg (1cc)

Other: - ActiveMatrix

1cc ActiveMatrix (Skye Biologics, Inc.)

Drug: - Lidocaine

Lidocaine 10 mg/mL (5cc)

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Houston, Texas

Status

Recruiting

Address

The University of Texas Health Science Center at Houston

Houston, Texas, 77030

Site Contact

Eric F Berkman, MD

[email protected]

713-314-4112

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