New allograft injection could thaw frozen shoulders better than steroids
NCT ID NCT05844930
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tested whether an injection made from human placental connective tissue (ActiveMatrix) works better than the usual steroid shot for frozen shoulder. 56 adults with frozen shoulder received either ActiveMatrix or a corticosteroid injection. Researchers measured pain and disability using a standard questionnaire over 6 months. The goal was to see if the new treatment is safe and more effective at easing pain and restoring movement.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Human placental connective tissue-derived allograft (ActiveMatrix) and corticosteroid (triamcinolone) injection
- What this could lead to
- If it works, this could offer a new treatment option for frozen shoulder that may reduce pain and improve movement better than standard steroid injections.
- What could go wrong
- This is a small pilot study with only 56 participants, so results may not apply to everyone. The allograft is new for this condition, and its safety and effectiveness are still being tested.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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56 people
The number who actually took part.
- Started
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Jan 2023
- Finished
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Feb 2025
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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The University of Texas Health Science Center at Houston
Houston, Texas, 77030, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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