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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).

Condition

Eligibility

Eligible Ages
Between 18 Years and 75 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
Phase 4
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
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).
  • Drug: Corticosteroid
    Triamcinolone 20 mg (1cc)
    Other names:
    • Triamcinolone
  • Drug: Lidocaine
    Lidocaine 10 mg/mL (5cc)
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).
  • Other: ActiveMatrix
    1cc ActiveMatrix (Skye Biologics, Inc.)
    Other names:
    • Human Placental Connective Tissue-Derived Allograft
  • Drug: Lidocaine
    Lidocaine 10 mg/mL (5cc)

Recruiting Locations

The University of Texas Health Science Center at Houston
Houston, Texas 77030
Contact:
Eric F Berkman, MD
713-314-4112
Eric.F.Berkman@uth.tmc.edu

More Details

Status
Recruiting
Sponsor
The University of Texas Health Science Center, Houston

Study Contact

Eric F Berkman, MD
713-314-4112
Eric.F.Berkman@uth.tmc.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.