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Connective Tissue Allograft
ActiveMatrix vs Corticosteroid Injections for Frozen Shoulder
Phase 4
Recruiting
Led By Eric F Berkman, MD
Research Sponsored by The University of Texas Health Science Center, Houston
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months following injection
Awards & highlights
Study Summary
This trial compares a new shoulder treatment, ActiveMatrix®, to corticosteroid injections to see which is more effective for frozen shoulder.
Who is the study for?
This trial is for individuals with frozen shoulder (adhesive capsulitis) who've had pain for more than 6 weeks but less than a year. They must have no allergies to treatments, recent shoulder images, and agree to follow the study rules. Excluded are those with stroke history, blood issues, NSAID use other than Tylenol, prior shoulder treatment or surgery, other shoulder pathologies on imaging, or poorly controlled diabetes.Check my eligibility
What is being tested?
The study aims to compare ActiveMatrix®, a connective tissue allograft used in treating frozen shoulder against standard corticosteroid injections. Participants will receive either the new treatment or the standard one and their effectiveness in managing symptoms will be evaluated.See study design
What are the potential side effects?
Possible side effects may include reactions at injection site such as pain or swelling for both treatments. Corticosteroids can cause increased blood sugar levels and mood changes while information about ActiveMatrix®'s specific side effects isn't provided but could be similar.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months following injection
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months following injection
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Pain as assessed by the Shoulder Pain and Disability Index (SPADI)
Secondary outcome measures
Change in pain intensity as assessed by the Visual Analog Scale (VAS)
Change in range of motion as assessed by the Passive Range of Motion (PROM) assessment using a goniometer (left side)
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Intra-articular Injection of ActiveMatrix Plus LidocaineExperimental Treatment2 Interventions
Participants will receive an injection consisting of ActiveMatrix (1cc; Skye Biologics, Inc.) with Lidocaine 10 mg/ml (5cc).
Group II: Intra-articular Injection of Corticosteroid Plus LidocaineActive Control2 Interventions
Participants will receive a corticosteroid injection consisting of Triamcinolone 20 mg (1cc) with Lidocaine 10 mg/ml (5 cc).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lidocaine
2011
Completed Phase 4
~1360
Find a Location
Who is running the clinical trial?
The University of Texas Health Science Center, HoustonLead Sponsor
904 Previous Clinical Trials
320,947 Total Patients Enrolled
Skye Biologics, Inc.UNKNOWN
Eric F Berkman, MDPrincipal InvestigatorThe University of Texas Health Science Center, Houston
1 Previous Clinical Trials
60 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had a major injury to my shoulder.I have received treatment for this shoulder pain episode before.I use pain relievers other than Tylenol.I have had shoulder surgery before.I have been diagnosed with frozen shoulder.I have no allergies or reasons I can't receive the treatment.My diabetes is not well-managed.I have had a stroke before.I have had shoulder pain for more than 6 weeks but less than a year.I have a shoulder condition that is not frozen shoulder.I have a blood disorder.
Research Study Groups:
This trial has the following groups:- Group 1: Intra-articular Injection of Corticosteroid Plus Lidocaine
- Group 2: Intra-articular Injection of ActiveMatrix Plus Lidocaine
Awards:
This trial has 3 awards, including:- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many participants has this clinical trial enrolled thus far?
"That is correct. According to the information available on clinicaltrials.gov, this medical examination was opened for recruitment on March 1st of 2023 and has been recently updated in April 21st of 2023. It requires a total 50 participants that will be recruited from one center only."
Answered by AI
What potential hazards are associated with Intra-articular Injection of ActiveMatrix Plus Lidocaine?
"With a score of 3, our team at Power gauges Intra-articular Injection of ActiveMatrix Plus Lidocaine to be safe due to its approval status as this is a Phase 4 trial."
Answered by AI
Are new participants being inducted into this clinical trial presently?
"Affirmative. The information present on clinicaltrials.gov implies that this research programme is currently accepting patients; the trial was initialised on 3rd January 2023 and last modified 21st April 2023. This study seeks 50 test subjects from one medical centre."
Answered by AI
Is this research study accepting participants above the age of 30?
"This clinical trial is recruiting individuals of age eighteen or more, and less than seventy-five years."
Answered by AI
Who meets the inclusion criteria for this clinical trial?
"To fit the enrollment criteria for this research, participants must have adhesive capsulitis and be between 18 to 75 years in age. This clinical trial is looking for a total of 50 individuals."
Answered by AI
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