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

Adhesive Capsulitis Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05844930
• Other study ID #: HSC-MS-21-0706
• Status: Recruiting
• Phase: Phase 4
• Start date: January 3, 2023
• Est. completion date: December 1, 2024

Study information

• Verified date: April 2023
• Source: The University of Texas Health Science Center, Houston
• Contact: Eric F Berkman, MD
• Phone: 713-314-4112
• Email: Eric.F.Berkman[@]uth.tmc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 1, 2024
• Est. primary completion date: June 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Adhesive Capsulitis
• Bursitis

Intervention

Drug:
• Corticosteroid
Triamcinolone 20 mg (1cc)

Other:
• ActiveMatrix
1cc ActiveMatrix (Skye Biologics, Inc.)

Drug:
• Lidocaine
Lidocaine 10 mg/mL (5cc)

Locations

Country	Name	City	State
United States	The University of Texas Health Science Center at Houston	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston	Skye Biologics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline
Primary	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.	4 weeks following injection
Primary	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.	12 weeks following injection
Primary	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.	6 months following injection
Secondary	Change in pain intensity as assessed by the Visual Analog Scale (VAS)	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.	Baseline
Secondary	Change in pain intensity as assessed by the Visual Analog Scale (VAS)	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.	4 weeks following injection
Secondary	Change in pain intensity as assessed by the Visual Analog Scale (VAS)	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.	12 weeks following injection
Secondary	Change in pain intensity as assessed by the Visual Analog Scale (VAS)	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.	6 months following injection
Secondary	Change in range of motion as assessed by the Passive Range of Motion (PROM) assessment using a goniometer (left side)	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.	Baseline
Secondary	Change in range of motion as assessed by the Passive Range of Motion (PROM) assessment using a goniometer (left side)	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.	4 weeks following injection
Secondary	Change in range of motion as assessed by the Passive Range of Motion (PROM) assessment using a goniometer (left side)	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.	12 weeks following injection
Secondary	Change in range of motion as assessed by the Passive Range of Motion (PROM) assessment using a goniometer (left side)	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.	6 months following injection