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Completed

NCT Number: NCT05844930

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

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).

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Key information

Conditions

Adhesive Capsulitis Bursitis Joint Diseases Musculoskeletal Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Corticosteroid

Drug

Triamcinolone 20 mg (1cc)

Other names: Triamcinolone

ActiveMatrix

Other

1cc ActiveMatrix (Skye Biologics, Inc.)

Other names: Human Placental Connective Tissue-Derived Allograft

Lidocaine

Drug

Lidocaine 10 mg/mL (5cc)

Primary outcomes

  1. Change in Pain as Assessed by the Shoulder Pain and Disability Index (SPADI)

    Time frame: Baseline, Week 4

    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. The change in score is reported as [(SPADI at Week 4) - (SPADI at baseline)] -- a negative value indicates pain and disability decreased over time.

  2. Change in Pain as Assessed by the Shoulder Pain and Disability Index (SPADI)

    Time frame: Baseline, Week 12

    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. The change in score is reported as [(SPADI at Week 12) - (SPADI at baseline)] -- a negative value indicates pain and disability decreased over time.

  3. Change in Pain as Assessed by the Shoulder Pain and Disability Index (SPADI)

    Time frame: Baseline, week 24

    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. The change in score is reported as [(SPADI at 6 months) - (SPADI at baseline)] -- a negative value indicates pain and disability decreased over time.

Secondary outcomes

  1. Change in Pain Intensity as Assessed by the Visual Analog Scale (VAS)

    Time frame: Baseline, week 4

    Visual Analog Scale (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. The change in pain intensity will be reported as [(VAS at week 4) - (VAS at baseline)] - a negative value indicates a decrease in pain intensity.

  2. Change in Pain Intensity as Assessed by the Visual Analog Scale (VAS)

    Time frame: Baseline, week 12

    Visual Analog Scale (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. The change in pain intensity will be reported as [(VAS at week 12) - (VAS at baseline)] - a negative value indicates a decrease in pain intensity.

  3. Change in Pain Intensity as Assessed by the Visual Analog Scale (VAS)

    Time frame: Baseline, week 24

    Visual Analog Scale (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. The change in pain intensity will be reported as [(VAS at 6 months) - (VAS at baseline)] - a negative value indicates a decrease in pain intensity.

  4. Change in Shoulder Function as Assessed by the American Shoulder and Elbow Surgeons (ASES) Score

    Time frame: Baseline, Week 4

    The American shoulder and elbow surgeons (ASES) score assess shoulder function. ASES Score ranges from 0 to 100, with a score of 0 indicating a worse shoulder condition and a score of 100 indicating a better shoulder condition. The change in score is reported as [(ASES score at week 4) - (ASES score at baseline)] - a positive value indicates an improvement in shoulder function over time.

  5. Change in Shoulder Function as Assessed by the American Shoulder and Elbow Surgeons (ASES) Score

    Time frame: Baseline, Week 12

    The American shoulder and elbow surgeons (ASES) score assess shoulder function. ASES Score ranges from 0 to 100, with a score of 0 indicating a worse shoulder condition and a score of 100 indicating a better shoulder condition. The change in score is reported as [(ASES score at week 12) - (ASES score at baseline)] - a positive value indicates an improvement in shoulder function over time.

  6. Change in American Shoulder and Elbow Surgeons (ASES) Score

    Time frame: Baseline, Week 24

    The American shoulder and elbow surgeons (ASES) score assess shoulder function. ASES Score ranges from 0 to 100, with a score of 0 indicating a worse shoulder condition and a score of 100 indicating a better shoulder condition. The change in score is reported as [(ASES score at week 24) - (ASES score at baseline)] - a positive value indicates an improvement in shoulder function over time

  7. Change in Range of Motion as Assessed by the Passive Range of Motion (PROM) Assessment Using a Goniometer (Abduction Internal Rotation)

    Time frame: Baseline, Week 4

    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. Change from baseline will be calculated, with a positive values indicating improved range of motion.

  8. Change in Range of Motion as Assessed by the Passive Range of Motion (PROM) Assessment Using a Goniometer (Abduction Internal Rotation)

    Time frame: Baseline, Week 12

    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. Change from baseline will be calculated, with a positive values indicating improved range of motion.

  9. Change in Range of Motion as Assessed by the Passive Range of Motion (PROM) Assessment Using a Goniometer (Abduction Internal Rotation)

    Time frame: Baseline, Week 24

    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. Change from baseline will be calculated, with a positive values indicating improved range of motion.

  10. Change in Range of Motion as Assessed by the Passive Range of Motion (PROM) Assessment Using a Goniometer (Abduction External Rotation)

    Time frame: Baseline, Week 4

    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. Change from baseline will be calculated, with a positive values indicating improved range of motion.

  11. Change in Range of Motion as Assessed by the Passive Range of Motion (PROM) Assessment Using a Goniometer (Abduction External Rotation)

    Time frame: Baseline, Week 12

    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. Change from baseline will be calculated, with a positive values indicating improved range of motion.

  12. Change in Range of Motion as Assessed by the Passive Range of Motion (PROM) Assessment Using a Goniometer (Abduction External Rotation)

    Time frame: Baseline, Week 24

    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. Change from baseline will be calculated, with a positive values indicating improved range of motion.

  13. Change in Range of Motion as Assessed by the Passive Range of Motion (PROM) Assessment Using a Goniometer (Forward Elevation)

    Time frame: Baseline, Week 4

    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. Change from baseline will be calculated, with a positive values indicating improved range of motion.

  14. Change in Range of Motion as Assessed by the Passive Range of Motion (PROM) Assessment Using a Goniometer (Forward Elevation)

    Time frame: Baseline, Week 12

    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. Change from baseline will be calculated, with a positive values indicating improved range of motion.

  15. Change in Range of Motion as Assessed by the Passive Range of Motion (PROM) Assessment Using a Goniometer (Forward Elevation)

    Time frame: Baseline, Week 24

    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. Change from baseline will be calculated, with a positive values indicating improved range of motion.

  16. Change in Range of Motion as Assessed by the Passive Range of Motion (PROM) Assessment Using a Goniometer (Abduction)

    Time frame: Baseline, Week 4

    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. Change from baseline will be calculated, with a positive values indicating improved range of motion.

  17. Change in Range of Motion as Assessed by the Passive Range of Motion (PROM) Assessment Using a Goniometer (Abduction)

    Time frame: Baseline, Week 12

    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. Change from baseline will be calculated, with a positive values indicating improved range of motion.

  18. Change in Range of Motion as Assessed by the Passive Range of Motion (PROM) Assessment Using a Goniometer (Abduction)

    Time frame: Baseline, Week 24

    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. Change from baseline will be calculated, with a positive values indicating improved range of motion.

  19. Change in Range of Motion as Assessed by the Passive Range of Motion (PROM) Assessment Using a Goniometer (External Rotation)

    Time frame: Baseline, Week 4

    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. Change from baseline will be calculated, with a positive values indicating improved range of motion.

  20. Change in Range of Motion as Assessed by the Passive Range of Motion (PROM) Assessment Using a Goniometer (External Rotation)

    Time frame: Baseline, Week 12

    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. Change from baseline will be calculated, with a positive values indicating improved range of motion.

  21. Change in Range of Motion as Assessed by the Passive Range of Motion (PROM) Assessment Using a Goniometer (External Rotation)

    Time frame: Baseline, Week 24

    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. Change from baseline will be calculated, with a positive values indicating improved range of motion.

  22. Change in Range of Motion as Assessed by the Passive Range of Motion (PROM) Assessment Using a Goniometer (Neutral Internal Rotation)

    Time frame: Baseline, Week 4

    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. Change from baseline will be calculated, with a positive values indicating improved range of motion.

  23. Change in Range of Motion as Assessed by the Passive Range of Motion (PROM) Assessment Using a Goniometer (Neutral Internal Rotation)

    Time frame: Baseline, Week 12

    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. Change from baseline will be calculated, with a positive values indicating improved range of motion.

  24. Change in Range of Motion as Assessed by the Passive Range of Motion (PROM) Assessment Using a Goniometer (Neutral Internal Rotation)

    Time frame: Baseline, Week 24

    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. Change from baseline will be calculated, with a positive values indicating improved range of motion.

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Collaborators

  • Skye Biologics, Inc.

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
May 6, 2023
Registry last updated
Mar 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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