Rotator Cuff TendinopathyNCT06712290
Connective Tissue Matrix Compared to Steroid Injections for Rotator Cuff Tendinopathy
A study testing celgene and Corticosteroid in people with Rotator Cuff Tendinopathy, run by Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute) at 1 site in United States.
Trial summary
The goal of the study is to see which is better at treating patients which rotator cuff tendinopathy (RCT): a single injection of Connective Tissue Matrix boost (CTM) or a steroid shot. Patients will be randomized (like flipping a coin) to the treatment. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Rotator Cuff Tendinopathy
- What is being tested?
- celgene and Corticosteroid
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Nov 2024to 17 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 18-80 years old with rotator cuff tendinopathy
- A corticosteroid or CTM-type injection was determined by the clinician to be the proper medical treatment course and patient is willing to undergo the injection
Who cannot join
- Patients with adhesive capsulitis
- Patients with acromio-clavicular joint impingement, retracted tears, significant labral lesions or significant glenohumeral arthrosis
- Patients with joint instability
- History of shoulder surgery or corticosteroid injection in the past 3 months
- Patients with a history of chronic steroid treatment for any medical reason
- Patients with medical conditions that may affect healing, such as
Show all 11Show fewer
- End-stage renal disease
- Uncontrolled diabetes
- Peripheral vascular disease
- Severe and/or systemic immunocompromising conditions such as Lupus or HIV infection
- Patients who are pregnant or breast feeding
Trial locations and contacts
1 site in 1 country.
United States1 site
Allegheny Health Network Federal North Medical Office Building
Pittsburgh, Pennsylvania, 15212
About this study
Official title: Connective Tissue Matrix (CTM) Compared to Corticosteroid Injections: A Pilot Randomized Controlled Trial
The goal of the study is to see which is better at treating patients which rotator cuff tendinopathy (RCT): a single injection of Connective Tissue Matrix boost (CTM) or a steroid shot.
Patients will be randomized (like flipping a coin) to the treatment. Patients and researchers will be blinded (not know) what group the patients are in.
Patients will come back to the study clinic at 6 weeks, 3 months and 6 months after the shot to answer questionnaires, have a physical exam, and complete physical function tests to check their shoulder.
Read the detailed description
CTM vs. Steroid is a double-blind randomized controlled trial. Patients will be randomized to CTM Boost or Kenalog-40 (corticosteroid). Patients will be followed for six months and have three follow-up visits where they will have a physical exam, complete questionnaires, have a physical exam, including physical functional assessments, be screened for adverse events. Data will be collected from their medical chart after each visit.
CTM Boost (CTM Biomedical, Miami, FL) is a tissue allograft derived from decellularized, particulate human placental connective tissue. It is regulated as a minimally-manipulated human cell, tissue, and cellular and tissue-based product (HCT/P) biologic by the FDA and is marketed for homologous use to supplement or replace damaged or inadequate connective tissue. It is implanted via injection into the tissue. CTM Boost is available in a range of volumes. In this study, the 2.0cc volume of CTM Boost will be administered by injection directly into the subacromial space using a 20G needle.
Kenalog-40 is a long-acting corticosteroid injection for intramuscular (into the muscle) or intra-articular (into the joints) use. It may be used to treat many different types of inflammatory conditions. In this study, a 2.0cc dose injection of kenalog-40 will be administered directly into the subacromial space using a 20G needle (for patients randomized to this control arm).
Study Questionnaires are as follows:
- WORC: The WORC has 21 items in four domains, including physical symptoms (10 questions), sports/recreation/work (4 questions), lifestyle (4 questions) and emotions (3 questions). Raw scores range from 0 to 2100, with a higher score indicating decreased quality of life because of pathological condition of the rotator cuff.
- SANE: The Single Assessment Numeric Evaluation (SANE) is a patient rating from 0-100. Patients rate their current illness score in relation to their pre-injury baseline. SANE scores are most commonly used by orthopedic sports specialist surgeons, and usually for the shoulder and the knee.
- VAS: The Visual Analogue Scale (VAS) measures pain intensity. The VAS consists of a 10cm line, with two end points representing 0 (no pain) and 10 (pain as bad as it could possibly be).
- ASES: The ASES score is a 10-item measure of shoulder pain and function. Pain is assessed on a 10-cm visual analog scale (VAS) and accounts for 50% of the total score. The remaining 50% of the score is determined by the responses to 10 4-point Likert-scale questions related to physical function
- Functional Assessments: various arm/shoulder exercises with dumbbells, weights or resistance. Time until patient is fatigued and/or number of repetitions will be measured.
- These tests will include the following:
- Empty can exercise with dumbbell resistance: Arm held in a position with weighted resistance, while measuring number of seconds to fatigue (or unable to maintain arm at 90 degrees).
- Side-lying external rotation with dumbbell resistance: Lie on side (opposite shoulder) with weight held in hand, elbow flexed to 90 degrees while rotate through a full range of motion at the shoulder. The number of repetitions during a 30-second period are recorded.
Full can exercise with dumbbell resistance: Stand parallel to wall with the handheld in a fist and shoulder forward flexed parallel to the floor. A measuring stick will be used to measure how far forward on the yardstick patient can reach. The number of repetitions during a 60-second period are recorded.
External rotation of shoulder at 0 and 90 degrees with Thera-Band resistance. Patient will be instructed to perform rapid swinging motions in a 30-degree arc until fatigued.
Safety Evaluation:
- Infection
- Tear of the tendon
- Shoulder stiffness
- Admission to the hospital for a shoulder-related issue
- Surgical rotator cuff repair or subacromial decompression.
Data collected from a medical record review:
MRN Age Gender Weight Height Comorbidities Duration of symptoms Smoking status Diabetes Shoulder imaging reports from pre-enrollment MRI/xray Progress/Office notes Concomitant Medication
- Conditions
- Rotator Cuff Tendinopathy
- Being tested
- celgene, Corticosteroid
- Keywords
- Shoulder, Rotator cuff, Tendinopathy
- Medical subject headings
- Tendinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
celgeneDrug
Also called CTM boost
CTM Boost (CTM Biomedical, Miami, FL) is a decellularized Human Cellular and Tissue Based Allograft (HCT/P) derived from placental connective tissue. It is marketed as an allograft for homologous use to supplement or replace damaged or inadequate connective tissue. It is regulated as a minimally-manipulated biologic by the FDA and is marketed as an allograft for homologous use to supplement or replace damaged or inadequate connective tissue. It is administered applied into the tissue via injection.
Participant will undergo a single injection of 2.0cc of the injectable CTM allograft, administered using a 20G needle in the subacromial space. 3mL of ropivacaine will be mixed into the syringe prior to administration of the injection. Posttreatment pain control (hydrocodone/acetaminophen #20 5/500 mg) will be used.
CorticosteroidDrug
Also called kenalog
Kenalog-40 is a long-acting corticosteroid injection for intramuscular (into the muscle) or intra-articular (into the joints) use. It may be used to treat many different types of inflammatory conditions. In this study, a 2.0cc dose injection of Kenalog-40 will be administered directly into the subacromial space using a 20G needle. 3mL of ropivacaine will be injected along with the steroid (as part of the same injection). Posttreatment pain control (hydrocodone/acetaminophen #20 5/500 mg) will be used.
| Study group | Role | What they receive |
|---|---|---|
| Corticosteroid | Placebo comparator | Kenalog-40 is a long-acting corticosteroid injection for intramuscular (into the muscle) or intra-articular (into the joints) use. It may be used to treat many different types of inflammatory conditions.
In this study, a 2.0cc dose injection of Kenalog-40 will be administered directly into the subacromial space using a 20G needle. 3mL of ropivacaine will be injected along with the steroid (as part of the same injection). Posttreatment pain control (hydrocodone/acetaminophen #20 5/500 mg) will be used. Receives: Drug: Corticosteroid |
| CTM Boost | Experimental | TM Boost (CTM Biomedical, Miami, FL) is a decellularized Human Cellular and Tissue Based Allograft (HCT/P) derived from placental connective tissue. It is marketed as an allograft for homologous use to supplement or replace damaged or inadequate connective tissue. It is regulated as a minimally-manipulated biologic by the FDA and is marketed as an allograft for homologous use to supplement or replace damaged or inadequate connective tissue. It is administered applied into the tissue via injection. Participant will undergo a single injection of 2.0cc of the injectable CTM allograft, administered using a 20G needle in the subacromial space. 3mL of ropivacaine will be mixed into the syringe prior to administration of the injection. Posttreatment pain control (hydrocodone/acetaminophen #20 5/500 mg) will be used. Receives: Drug: celgene |
What is being measured
The primary outcome is the main question the study is designed to answer.
Raw WORC Score at 3 Month Visit
The primary outcome will be raw WORC score at the Month 3 visit. WORC is a patient-reported quality of life outcome measure for patients with rotator cuff disorders. The raw score obtained from scoring a completed questionnaire ranges from 0 to 2100, where higher scores indicate poorer quality of life.
Measured: 3 Month Visit
Secondary outcomes (9)
WORC Score
WORC: The WORC has 21 items in four domains, including physical symptoms (10 questions), sports/recreation/work (4 questions), lifestyle (4 questions) and emotions (3 questions). Raw scores range from 0 to 2100, with a higher score indicating decreased quality of life because of pathological condition of the rotator cuff.
Measured: Baseline, Week 6, Month 3, Month 6 Visits
VAS: The Visual Analogue Scale
The VAS consists of a 10cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be')
Measured: Baseline, Week 6, Month 3, Month 6 Visits
SANE: The Single Assessment Numeric Evaluation
The SANEpatient rating from 0-100. Patients rate their current illness score in relation to their pre-injury baseline. SANE scores are most commonly used by orthopedic sports specialist surgeons, and usually for the shoulder and the knee.
Measured: Baseline, Week 6, Month 3, Month 6 Visits
ASES
The ASES score is a 10-item measure of shoulder pain and function. Pain is assessed on a 10-cm visual analog scale (VAS) and accounts for 50% of the total score. The remaining 50% of the score is determined by the responses to 10 4-point Likert-scale questions related to physical function
Measured: Baseline, Week 6, Month 3, Month 6 Visits
Functional Assessments: Empty can exercise
Empty can exercise with dumbbell resistance: Arm held in a position with weighted resistance, while measuring number of seconds to fatigue (or unable to maintain arm at 90 degrees). Time until patient is fatigued
Measured: Baseline, Week 6, Month 3, Month 6 Visits
Functional Assessments: External Rotation with Dumbell
Side-lying external rotation with dumbbell resistance: Lie on side (opposite shoulder) with weight held in hand, elbow flexed to 90 degrees while rotate through a full range of motion at the shoulder. The number of repetitions during a 30-second period are recorded.
Measured: Baseline, Week 6, Month 3, Month 6 Visits
Functional Assessments: Full can exercise with dumbbell resistance
Stand parallel to wall with the handheld in a fist and shoulder forward flexed parallel to the floor. A measuring stick will be used to measure how far forward on the yardstick patient can reach. The number of repetitions during a 60-second period are recorded.
Measured: Baseline, Week 6, Month 3, Month 6 Visits
Functional Assessments: External rotation of shoulder at 0 and 90 degrees with Thera-Band resistance
Patient will be instructed to perform rapid swinging motions in a 30-degree arc until fatigued.
Measured: Baseline, Week 6, Month 3, Month 6 Visits
Safety Evaluations; Adverse Events; Serious Adverse Events
- Infection
- Tear of the tendon
- Shoulder stiffness
- Admission to the hospital for a shoulder-related issue
- Surgical rotator cuff repair or subacromial decompression.
Measured: Week 6, Month 3, Month 6 Visits
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2024
- Study start25 Nov 2024
- Primary completion17 Dec 2025
- Study completion17 Dec 2025
Why it stopped: No participants met eligibility and the study was closed.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Rotator Cuff TendinopathyStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
- Sponsor type
- University, hospital or other
- Collaborators
- CTM Biomedical
- Responsible party
- Principal investigator, Sam Akhavan, MD, Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06712290
- Sponsor's protocol ID
- 2024-118
- Status last verified
- Dec 2025
- First submitted
- 25 Nov 2024
- Last updated
- 23 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Braun C, Handoll HH. Estimating the Minimal Important Difference for the Western Ontario Rotator Cuff Index (WORC) in adults with shoulder pain associated with partial-thickness rotator cuff tears. Musculoskelet Sci Pract. 2018 Jun;35:30-33. doi: 10.1016/j.msksp.2018.02.003. Epub 2018 Feb 12.
PubMed 29471221Chen J, Svensson J, Sundberg CJ, Ahmed AS, Ackermann PW. FGF gene expression in injured tendons as a prognostic biomarker of 1-year patient outcome after Achilles tendon repair. J Exp Orthop. 2021 Mar 11;8(1):20. doi: 10.1186/s40634-021-00335-0.
PubMed 33694106Dean BJ, Snelling SJ, Dakin SG, Murphy RJ, Javaid MK, Carr AJ. Differences in glutamate receptors and inflammatory cell numbers are associated with the resolution of pain in human rotator cuff tendinopathy. Arthritis Res Ther. 2015 Jul 10;17(1):176. doi: 10.1186/s13075-015-0691-5.
PubMed 26160609Giovannetti de Sanctis E, Franceschetti E, De Dona F, Palumbo A, Paciotti M, Franceschi F. The Efficacy of Injections for Partial Rotator Cuff Tears: A Systematic Review. J Clin Med. 2020 Dec 25;10(1):51. doi: 10.3390/jcm10010051.
PubMed 33375716
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Connective Tissue Matrix (CTM) Compared to Corticosteroid Injections: A Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06712290
- Acronym / sponsor ID
- 2024-118
- Conditions
- Rotator Cuff Tendinopathy
- Keywords
- Shoulder, Rotator cuff, Tendinopathy
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No participants met eligibility and the study was closed.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)University, hospital or other
- Collaborators
- CTM Biomedical
- Study start
- 25 Nov 2024 (actual)
- Primary completion
- 17 Dec 2025 (actual)
- Study completion
- 17 Dec 2025 (actual)
- First posted
- 2 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of the study is to see which is better at treating patients which rotator cuff tendinopathy (RCT): a single injection of Connective Tissue Matrix boost (CTM) or a steroid shot.
Patients will be randomized (like flipping a coin) to the treatment. Patients and researchers will be blinded (not know) what group the patients are in.
Patients will come back to the study clinic at 6 weeks, 3 months and 6 months after the shot to answer questionnaires, have a physical exam, and complete physical function tests to check their shoulder.
Detailed description
CTM vs. Steroid is a double-blind randomized controlled trial. Patients will be randomized to CTM Boost or Kenalog-40 (corticosteroid). Patients will be followed for six months and have three follow-up visits where they will have a physical exam, complete questionnaires, have a physical exam, including physical functional assessments, be screened for adverse events. Data will be collected from their medical chart after each visit.
CTM Boost (CTM Biomedical, Miami, FL) is a tissue allograft derived from decellularized, particulate human placental connective tissue. It is regulated as a minimally-manipulated human cell, tissue, and cellular and tissue-based product (HCT/P) biologic by the FDA and is marketed for homologous use to supplement or replace damaged or inadequate connective tissue. It is implanted via injection into the tissue. CTM Boost is available in a range of volumes. In this study, the 2.0cc volume of CTM Boost will be administered by injection directly into the subacromial space using a 20G needle.
Kenalog-40 is a long-acting corticosteroid injection for intramuscular (into the muscle) or intra-articular (into the joints) use. It may be used to treat many different types of inflammatory conditions. In this study, a 2.0cc dose injection of kenalog-40 will be administered directly into the subacromial space using a 20G needle (for patients randomized to this control arm).
Study Questionnaires are as follows:
- WORC: The WORC has 21 items in four domains, including physical symptoms (10 questions), sports/recreation/work (4 questions), lifestyle (4 questions) and emotions (3 questions). Raw scores range from 0 to 2100, with a higher score indicating decreased quality of life because of pathological condition of the rotator cuff.
- SANE: The Single Assessment Numeric Evaluation (SANE) is a patient rating from 0-100. Patients rate their current illness score in relation to their pre-injury baseline. SANE scores are most commonly used by orthopedic sports specialist surgeons, and usually for the shoulder and the knee.
- VAS: The Visual Analogue Scale (VAS) measures pain intensity. The VAS consists of a 10cm line, with two end points representing 0 (no pain) and 10 (pain as bad as it could possibly be).
- ASES: The ASES score is a 10-item measure of shoulder pain and function. Pain is assessed on a 10-cm visual analog scale (VAS) and accounts for 50% of the total score. The remaining 50% of the score is determined by the responses to 10 4-point Likert-scale questions related to physical function
- Functional Assessments: various arm/shoulder exercises with dumbbells, weights or resistance. Time until patient is fatigued and/or number of repetitions will be measured.
- These tests will include the following:
- Empty can exercise with dumbbell resistance: Arm held in a position with weighted resistance, while measuring number of seconds to fatigue (or unable to maintain arm at 90 degrees).
- Side-lying external rotation with dumbbell resistance: Lie on side (opposite shoulder) with weight held in hand, elbow flexed to 90 degrees while rotate through a full range of motion at the shoulder. The number of repetitions during a 30-second period are recorded.
Full can exercise with dumbbell resistance: Stand parallel to wall with the handheld in a fist and shoulder forward flexed parallel to the floor. A measuring stick will be used to measure how far forward on the yardstick patient can reach. The number of repetitions during a 60-second period are recorded.
External rotation of shoulder at 0 and 90 degrees with Thera-Band resistance. Patient will be instructed to perform rapid swinging motions in a 30-degree arc until fatigued.
Safety Evaluation:
- Infection
- Tear of the tendon
- Shoulder stiffness
- Admission to the hospital for a shoulder-related issue
- Surgical rotator cuff repair or subacromial decompression.
Data collected from a medical record review:
MRN Age Gender Weight Height Comorbidities Duration of symptoms Smoking status Diabetes Shoulder imaging reports from pre-enrollment MRI/xray Progress/Office notes Concomitant Medication
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 |
|---|---|---|
| Corticosteroid | Placebo comparator | Drug: CorticosteroidKenalog-40 is a long-acting corticosteroid injection for intramuscular (into the muscle) or intra-articular (into the joints) use. It may be used to treat many different types of inflammatory conditions. In this study, a 2.0cc dose injection of Kenalog-40 will be administered directly into the subacromial space using a 20G needle. 3mL of ropivacaine will be injected along with the steroid (as part of the same injection). Posttreatment pain control (hydrocodone/acetaminophen #20 5/500 mg) will be used. |
| CTM Boost | Experimental | Drug: celgeneTM Boost (CTM Biomedical, Miami, FL) is a decellularized Human Cellular and Tissue Based Allograft (HCT/P) derived from placental connective tissue. It is marketed as an allograft for homologous use to supplement or replace damaged or inadequate connective tissue. It is regulated as a minimally-manipulated biologic by the FDA and is marketed as an allograft for homologous use to supplement or replace damaged or inadequate connective tissue. It is administered applied into the tissue via injection. Participant will undergo a single injection of 2.0cc of the injectable CTM allograft, administered using a 20G needle in the subacromial space. 3mL of ropivacaine will be mixed into the syringe prior to administration of the injection. Posttreatment pain control (hydrocodone/acetaminophen #20 5/500 mg) will be used. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients aged 18-80 years old with rotator cuff tendinopathy
- A corticosteroid or CTM-type injection was determined by the clinician to be the proper medical treatment course and patient is willing to undergo the injection
Key exclusion criteria (11 listed)
- Patients with adhesive capsulitis
- Patients with acromio-clavicular joint impingement, retracted tears, significant labral lesions or significant glenohumeral arthrosis
- Patients with joint instability
- History of shoulder surgery or corticosteroid injection in the past 3 months
- Patients with a history of chronic steroid treatment for any medical reason
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 |
|---|---|---|
| celgeneAlso: CTM boostCTM Boost (CTM Biomedical, Miami, FL) is a decellularized Human Cellular and Tissue Based Allograft (HCT/P) derived from placental connective tissue. It is marketed as an allograft for homologous use to supplement or replace damaged or inadequate connective tissue. It is regulated as a minimally-manipulated biologic by the FDA and is marketed as an allograft for homologous use to supplement or replace damaged or inadequate connective tissue. It is administered applied into the tissue via injection. Participant will undergo a single injection of 2.0cc of the injectable CTM allograft, administered using a 20G needle in the subacromial space. 3mL of ropivacaine will be mixed into the syringe prior to administration of the injection. Posttreatment pain control (hydrocodone/acetaminophen #20 5/500 mg) will be used. | Drug | CTM Boost |
| CorticosteroidAlso: kenalogKenalog-40 is a long-acting corticosteroid injection for intramuscular (into the muscle) or intra-articular (into the joints) use. It may be used to treat many different types of inflammatory conditions. In this study, a 2.0cc dose injection of Kenalog-40 will be administered directly into the subacromial space using a 20G needle. 3mL of ropivacaine will be injected along with the steroid (as part of the same injection). Posttreatment pain control (hydrocodone/acetaminophen #20 5/500 mg) will be used. | Drug | Corticosteroid |
Primary outcome
Raw WORC Score at 3 Month Visit
Time frame: 3 Month Visit
The primary outcome will be raw WORC score at the Month 3 visit. WORC is a patient-reported quality of life outcome measure for patients with rotator cuff disorders. The raw score obtained from scoring a completed questionnaire ranges from 0 to 2100, where higher scores indicate poorer quality of life.
9 secondary outcomes
WORC Score
Time frame: Baseline, Week 6, Month 3, Month 6 Visits
VAS: The Visual Analogue Scale
Time frame: Baseline, Week 6, Month 3, Month 6 Visits
SANE: The Single Assessment Numeric Evaluation
Time frame: Baseline, Week 6, Month 3, Month 6 Visits
ASES
Time frame: Baseline, Week 6, Month 3, Month 6 Visits
Functional Assessments: Empty can exercise
Time frame: Baseline, Week 6, Month 3, Month 6 Visits
Functional Assessments: External Rotation with Dumbell
Time frame: Baseline, Week 6, Month 3, Month 6 Visits
Functional Assessments: Full can exercise with dumbbell resistance
Time frame: Baseline, Week 6, Month 3, Month 6 Visits
Functional Assessments: External rotation of shoulder at 0 and 90 degrees with Thera-Band resistance
Time frame: Baseline, Week 6, Month 3, Month 6 Visits
Safety Evaluations; Adverse Events; Serious Adverse Events
Time frame: Week 6, Month 3, Month 6 Visits
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2025.
- Results publication: PubMed 29471221Braun C, Handoll HH. Estimating the Minimal Important Difference for the Western Ontario Rotator Cuff Index (WORC) in adults with shoulder pain associated with partial-thickness rotator cuff tears. Musculoskelet Sci Pract. 2018 Jun;35:30-33. doi: 10.1016/j.msksp.2018.02.003. Epub 2018 Feb 12.
- Results publication: PubMed 33694106Chen J, Svensson J, Sundberg CJ, Ahmed AS, Ackermann PW. FGF gene expression in injured tendons as a prognostic biomarker of 1-year patient outcome after Achilles tendon repair. J Exp Orthop. 2021 Mar 11;8(1):20. doi: 10.1186/s40634-021-00335-0.
- Results publication: PubMed 26160609Dean BJ, Snelling SJ, Dakin SG, Murphy RJ, Javaid MK, Carr AJ. Differences in glutamate receptors and inflammatory cell numbers are associated with the resolution of pain in human rotator cuff tendinopathy. Arthritis Res Ther. 2015 Jul 10;17(1):176. doi: 10.1186/s13075-015-0691-5.
- Results publication: PubMed 33375716Giovannetti de Sanctis E, Franceschetti E, De Dona F, Palumbo A, Paciotti M, Franceschi F. The Efficacy of Injections for Partial Rotator Cuff Tears: A Systematic Review. J Clin Med. 2020 Dec 25;10(1):51. doi: 10.3390/jcm10010051.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing celgene and Corticosteroid in people with Rotator Cuff Tendinopathy, run by Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute) 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 2 inclusion and 11 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: withdrawn, as of the sponsor's last update on 23 Dec 2025. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Raw WORC Score at 3 Month Visit (time frame: 3 Month Visit). 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 NCT06712290, which also lists 4 linked publications.
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 23 Dec 2025.