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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
Drug Has Already Been Approved
No Placebo-Only Group
Pivotal Trial
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.
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.
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
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in Pain as assessed by the Shoulder Pain and Disability Index (SPADI)
Secondary study objectives
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)
Awards & Highlights
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.
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
~1370
Find a Location
Who is running the clinical trial?
Skye Biologics, Inc.UNKNOWN
The University of Texas Health Science Center, HoustonLead Sponsor
949 Previous Clinical Trials
344,975 Total Patients Enrolled
Eric F Berkman, MDPrincipal InvestigatorThe University of Texas Health Science Center, Houston
1 Previous Clinical Trials
60 Total Patients Enrolled
Media Library
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.
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