Adhesive CapsulitisPhase 4NCT05844930
A Study to Determine the Safety and Effectiveness of a Connective Tissue Allograft (ActiveMatrix) Verses Standard of Care in Adhesive Capsulitis of the Shoulder
A Phase 4 study testing Corticosteroid, ActiveMatrix and Lidocaine in people with Adhesive Capsulitis, run by The University of Texas Health Science Center, Houston at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Adhesive Capsulitis
- What is being tested?
- Corticosteroid, ActiveMatrix and Lidocaine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Jan 2023to 4 Feb 2025
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
About this study
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
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).
- Conditions
- Adhesive Capsulitis
- Being tested
- Corticosteroid, ActiveMatrix, Lidocaine
- Keywords
- Frozen Shoulder, musculoskeletal injuries
- Medical subject headings
- Bursitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CorticosteroidDrug
Also called Triamcinolone
Triamcinolone 20 mg (1cc)
ActiveMatrixOther
Also called Human Placental Connective Tissue-Derived Allograft
1cc ActiveMatrix (Skye Biologics, Inc.)
LidocaineDrug
Lidocaine 10 mg/mL (5cc)
| Study group | Role | What they receive |
|---|---|---|
| Intra-articular Injection of Corticosteroid Plus Lidocaine | Active comparator | Participants will receive a corticosteroid injection consisting of Triamcinolone 20 mg (1cc) with Lidocaine 10 mg/ml (5 cc). Receives: Drug: Corticosteroid; Drug: Lidocaine |
| Intra-articular Injection of ActiveMatrix Plus Lidocaine | Experimental | Participants will receive an injection consisting of ActiveMatrix (1cc; Skye Biologics, Inc.) with Lidocaine 10 mg/ml (5cc). Receives: Other: ActiveMatrix; Drug: Lidocaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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. The change in score is reported as [(SPADI at Week 4) - (SPADI at baseline)] -- a negative value indicates pain and disability decreased over time.
Measured: Baseline, Week 4
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. The change in score is reported as [(SPADI at Week 12) - (SPADI at baseline)] -- a negative value indicates pain and disability decreased over time.
Measured: Baseline, Week 12
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. The change in score is reported as [(SPADI at 6 months) - (SPADI at baseline)] -- a negative value indicates pain and disability decreased over time.
Measured: Baseline, week 24
Secondary outcomes (24)
Change in Pain Intensity as Assessed by the Visual Analog Scale (VAS)
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.
Measured: Baseline, week 4
Change in Pain Intensity as Assessed by the Visual Analog Scale (VAS)
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.
Measured: Baseline, week 12
Change in Pain Intensity as Assessed by the Visual Analog Scale (VAS)
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.
Measured: Baseline, week 24
Change in Shoulder Function as Assessed by the American Shoulder and Elbow Surgeons (ASES) Score
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.
Measured: Baseline, Week 4
Change in Shoulder Function as Assessed by the American Shoulder and Elbow Surgeons (ASES) Score
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.
Measured: Baseline, Week 12
Change in American Shoulder and Elbow Surgeons (ASES) Score
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
Measured: Baseline, Week 24
Change in Range of Motion as Assessed by the Passive Range of Motion (PROM) Assessment Using a Goniometer (Abduction Internal Rotation)
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.
Measured: Baseline, Week 4
Change in Range of Motion as Assessed by the Passive Range of Motion (PROM) Assessment Using a Goniometer (Abduction Internal Rotation)
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.
Measured: Baseline, Week 12
Change in Range of Motion as Assessed by the Passive Range of Motion (PROM) Assessment Using a Goniometer (Abduction Internal Rotation)
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.
Measured: Baseline, Week 24
Change in Range of Motion as Assessed by the Passive Range of Motion (PROM) Assessment Using a Goniometer (Abduction External Rotation)
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.
Measured: Baseline, Week 4
Change in Range of Motion as Assessed by the Passive Range of Motion (PROM) Assessment Using a Goniometer (Abduction External Rotation)
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.
Measured: Baseline, Week 12
Change in Range of Motion as Assessed by the Passive Range of Motion (PROM) Assessment Using a Goniometer (Abduction External Rotation)
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.
Measured: Baseline, Week 24
Change in Range of Motion as Assessed by the Passive Range of Motion (PROM) Assessment Using a Goniometer (Forward Elevation)
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.
Measured: Baseline, Week 4
Change in Range of Motion as Assessed by the Passive Range of Motion (PROM) Assessment Using a Goniometer (Forward Elevation)
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.
Measured: Baseline, Week 12
Change in Range of Motion as Assessed by the Passive Range of Motion (PROM) Assessment Using a Goniometer (Forward Elevation)
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.
Measured: Baseline, Week 24
Change in Range of Motion as Assessed by the Passive Range of Motion (PROM) Assessment Using a Goniometer (Abduction)
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.
Measured: Baseline, Week 4
Change in Range of Motion as Assessed by the Passive Range of Motion (PROM) Assessment Using a Goniometer (Abduction)
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.
Measured: Baseline, Week 12
Change in Range of Motion as Assessed by the Passive Range of Motion (PROM) Assessment Using a Goniometer (Abduction)
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.
Measured: Baseline, Week 24
Change in Range of Motion as Assessed by the Passive Range of Motion (PROM) Assessment Using a Goniometer (External Rotation)
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.
Measured: Baseline, Week 4
Change in Range of Motion as Assessed by the Passive Range of Motion (PROM) Assessment Using a Goniometer (External Rotation)
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.
Measured: Baseline, Week 12
Change in Range of Motion as Assessed by the Passive Range of Motion (PROM) Assessment Using a Goniometer (External Rotation)
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.
Measured: Baseline, Week 24
Change in Range of Motion as Assessed by the Passive Range of Motion (PROM) Assessment Using a Goniometer (Neutral Internal Rotation)
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.
Measured: Baseline, Week 4
Change in Range of Motion as Assessed by the Passive Range of Motion (PROM) Assessment Using a Goniometer (Neutral Internal Rotation)
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.
Measured: Baseline, Week 12
Change in Range of Motion as Assessed by the Passive Range of Motion (PROM) Assessment Using a Goniometer (Neutral Internal Rotation)
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.
Measured: Baseline, Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2023
- Study start3 Jan 2023
- Primary completion4 Feb 2025
- Study completion4 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Adhesive CapsulitisStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Skye Biologics, Inc.
- Responsible party
- Principal investigator, Eric F Berkman, The University of Texas Health Science Center, Houston
- Investigators
- Eric F Berkman, MD, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05844930
- Sponsor's protocol ID
- HSC-MS-21-0706
- Status last verified
- Feb 2026
- First submitted
- 21 Apr 2023
- Last updated
- 5 Mar 2026
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Nembhard OC, Pogoda JM, Helm JM, Gregory JM, Waters J, Sambasivan A, Meeks E, Shupe P, Berkman EF. Safety and Effectiveness of Placental Connective Tissue Matrix Allograft Versus Corticosteroid Injection in Adhesive Capsulitis: A Double-Blinded Prospective Randomized Study. JB JS Open Access. 2026 Aug 27;11(3):e26.00080. doi: 10.2106/JBJS.OA.26.00080. eCollection 2026 Jul-Sep.
PubMed 42639617
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05844930
- Acronym / sponsor ID
- HSC-MS-21-0706
- Conditions
- Adhesive Capsulitis
- Keywords
- Frozen Shoulder, musculoskeletal injuries
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Collaborators
- Skye Biologics, Inc.
- Study start
- 3 Jan 2023 (actual)
- Primary completion
- 4 Feb 2025 (actual)
- Study completion
- 4 Feb 2025 (actual)
- First posted
- 6 May 2023 (actual)
- Results
- Posted 18 Feb 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intra-articular Injection of Corticosteroid Plus Lidocaine | Active comparator | Drug: Corticosteroid, Drug: LidocaineParticipants will receive a corticosteroid injection consisting of Triamcinolone 20 mg (1cc) with Lidocaine 10 mg/ml (5 cc). |
| Intra-articular Injection of ActiveMatrix Plus Lidocaine | Experimental | Other: ActiveMatrix, Drug: LidocaineParticipants will receive an injection consisting of ActiveMatrix (1cc; Skye Biologics, Inc.) with Lidocaine 10 mg/ml (5cc). |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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).
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CorticosteroidAlso: TriamcinoloneTriamcinolone 20 mg (1cc) | Drug | Intra-articular Injection of Corticosteroid Plus Lidocaine |
| ActiveMatrixAlso: Human Placental Connective Tissue-Derived Allograft1cc ActiveMatrix (Skye Biologics, Inc.) | Other | Intra-articular Injection of ActiveMatrix Plus Lidocaine |
| LidocaineLidocaine 10 mg/mL (5cc) | Drug | Intra-articular Injection of ActiveMatrix Plus Lidocaine, Intra-articular Injection of Corticosteroid Plus Lidocaine |
Primary outcome
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.
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.
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.
24 secondary outcomes
Change in Pain Intensity as Assessed by the Visual Analog Scale (VAS)
Time frame: Baseline, week 4
Change in Pain Intensity as Assessed by the Visual Analog Scale (VAS)
Time frame: Baseline, week 12
Change in Pain Intensity as Assessed by the Visual Analog Scale (VAS)
Time frame: Baseline, week 24
Change in Shoulder Function as Assessed by the American Shoulder and Elbow Surgeons (ASES) Score
Time frame: Baseline, Week 4
Change in Shoulder Function as Assessed by the American Shoulder and Elbow Surgeons (ASES) Score
Time frame: Baseline, Week 12
Change in American Shoulder and Elbow Surgeons (ASES) Score
Time frame: Baseline, Week 24
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
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
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
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
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
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
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
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
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
Change in Range of Motion as Assessed by the Passive Range of Motion (PROM) Assessment Using a Goniometer (Abduction)
Time frame: Baseline, Week 4
Change in Range of Motion as Assessed by the Passive Range of Motion (PROM) Assessment Using a Goniometer (Abduction)
Time frame: Baseline, Week 12
Change in Range of Motion as Assessed by the Passive Range of Motion (PROM) Assessment Using a Goniometer (Abduction)
Time frame: Baseline, Week 24
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
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
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
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
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
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42639617Nembhard OC, Pogoda JM, Helm JM, Gregory JM, Waters J, Sambasivan A, Meeks E, Shupe P, Berkman EF. Safety and Effectiveness of Placental Connective Tissue Matrix Allograft Versus Corticosteroid Injection in Adhesive Capsulitis: A Double-Blinded Prospective Randomized Study. JB JS Open Access. 2026 Aug 27;11(3):e26.00080. doi: 10.2106/JBJS.OA.26.00080. eCollection 2026 Jul-Sep.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eric F Berkman, MD principal investigator
The University of Texas Health Science Center, Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Corticosteroid, ActiveMatrix and Lidocaine in people with Adhesive Capsulitis, run by The University of Texas Health Science Center, Houston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Feb 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Pain as Assessed by the Shoulder Pain and Disability Index (SPADI) (time frame: Baseline, Week 4). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05844930, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2026.