Rotator Cuff TendinopathyNCT06809543
Clinical Benefits and Safety of Tropho Tend in the Management of Painful Rotator Cuff Tendinopathy
A study testing Polynucleotides (Tropho Tend) and Rehabilitation physiotherapy in people with Rotator Cuff Tendinopathy, run by Mastelli S.r.l at 1 site in Italy.
Trial summary
This is a prospective, open label, controlled, exploratory clinical investigation aimed to evaluate the clinical benefit and safety of Tropho Tend in the conservative management of painful Rotator Cuff Tendinopathy (RCT). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rotator Cuff Tendinopathy
- What is being tested?
- Polynucleotides (Tropho Tend) and Rehabilitation physiotherapy
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteItaly
- Study dates
- 10 Dec 2024to 14 Apr 2026
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female patients ≥ 18 years of age, in good general health condition.
- Painful Rotator Cuff Tendinopathy (RCT) since ≥ 6 weeks.
- Pain and impaired functionality on a 0 to 10 cm-centimeter specifically designed Visual Analogue Scale (VAS) ≥ 4 cm at baseline visit.
- Rotator Cuff Tendinopathy (RCT) diagnosis, based on clinical examination.
- Tendon ultrasound (EUS) performed within one month of enrollment.
- Signed written informed consent.
Who cannot join
- Treatment with any investigational product within 6 months prior to clinical investigation entry.
- Patients with known hypersensitivity to the products (active compound and excipients) or any component or procedure used in the clinical investigation.
- Patients with para-tendinopathy, partial/total rupture, previous tendon surgery.
- Severe intercurrent illness (e.g.: uncontrolled diabetes mellitus, peripheral neuropathy, autoimmune or inflammatory condition, metabolic disorders, severe oncological conditions) that, in the opinion of the investigator, may put the patient at risk when participating in the clinical investigation or affect the patient's ability to take part in the clinical investigation .
- Patients treated with systemic and/or local steroids within the last 6 months, immunosuppressive drugs within the last 3 months, repeated use of non-steroidal anti-inflammatory drugs (NSAIDs) within the last week or occasional use within 24 hours.
- Recent history of drug and/or alcohol abuse (within the last 6 months).
- Pregnant or breastfeeding women
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Benefits and Safety of Tropho Tend in the Management of Painful Rotator Cuff Tendinopathy (RCT)
This is a prospective, open label, controlled, exploratory clinical investigation aimed to evaluate the clinical benefit and safety of Tropho Tend in the conservative management of painful Rotator Cuff Tendinopathy (RCT).
All subjects will be involved in the clinical investigation for 4 months for a total of 5 visits (T0= basal visit, T1, T2, T3, T4).
Read more
The control group will be represented by patients diagnosed with rotator cuff tendinopathy treated with rehabilitation physiotherapy (standard of care).
The therapy group will be represented by patients diagnosed with rotator cuff tendinopathy treated with rehabilitation physiotherapy + TrophoTend perilesional injection (TrophoTend will be added on to current standard of care).
All the screened patients at the baseline visit (T0), after checking the inclusion/exclusion criteria, will be prospectively included in the clinical investigation, in a 1:1 randomization. Patients will be randomly assigned to the "control group" (N=30pts), receiving rehabilitation physiotherapy (standard of care), or to the "therapy group" (N=30 pts), receiving Tropho Tend as a add on therapy to the rehabilitation physiotherapy.
Total duration of Clinical Investigation will be 12 months: 2-4 months for patients screening and enrolment; 1 month of therapy administration (3 perilesional injections 2 weeks apart); 3 months of follow-up; 2-4 months for data analysis and final report/paper elaboration.
At the baseline visit (T0), an ultrasound evaluation (EUS) has to be performed to assess tendon condition. If an EUS evaluation performed within one month from T0 is available, this will be considered acceptable. This first evaluation has to be compared with another EUS performed at the final visit to obtain a qualitative description of the ultrasound appearance of the tendon after the treatment.
Patients' enrolment will take 2-4 months. Tropho Tend will be administrated at T0 (basal visit) at T1 (2 weeks) and at T2 (4 weeks) for a total duration of treatment of 1 month.
Follow-up will be performed at T3 (8 weeks) and T4 (12 weeks= 3 months). End of the clinical investigation will be considered the last visit for the last enrolled patient.
A 40% reduction in mean VAS scores between the "Tropho Tend therapy group" and the "control group" is considered as reflecting meaningful clinical improvement for the patient.
At the final visit, the patient has to rate his/her satisfaction with the treatment using a 5-points Likert scale, where 1=very dissatisfied, 2=dissatisfied, 3=neutral, 4=satisfied, 5=highly satisfied.
- Conditions
- Rotator Cuff Tendinopathy
- Being tested
- Polynucleotides (Tropho Tend), Rehabilitation physiotherapy
- Keywords
- Polynucleotides, PN HPT, Mastelli, Rotator cuff tendinopathy, Tendinopathy
- Medical subject headings
- Tendinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Polynucleotides (Tropho Tend)Device
Tropho Tend is administered by injecting the solution at level of muscular-tendineal (MJT) or osteo-tendineal junctions (OTJ) using a fine-gauge needle (usually 25-30G).
Before injecting the product, the target area will be disinfected with alcohol or another antiseptic, with the antiseptic removed with physiologic sterile solution.
Total number of treatments will consist in 3 Tropho Tend administrations: at T0 - basal visit;
- T1 - after 2 weeks;
- T3 - after 4 weeks.
Rehabilitation physiotherapyProcedure or surgery
Rehabilitation physiotherapy (standard of care)
| Study group | Role | What they receive |
|---|---|---|
| Therapy group | Experimental | Not described Receives: Device: Polynucleotides (Tropho Tend) |
| Control group | Active comparator | Not described Receives: Procedure: Rehabilitation physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Variation of pain and functional impairment
The Primary Endpoint measure is the variation of VAS Visual Analogue Scale of pain and of function (VAS; 0-10 cm, where 0= no pain or no function impairment and 10= worse pain or function impairment) in the "Tropho Tend therapy group" compared with the "control group". A 40% reduction in mean VAS scores between the "Tropho Tend therapy group" and the "control group" is considered as reflecting meaningful clinical improvement for the patient.
Measured: All visits from baseline to the last follow-up after 12 weeks from the end of the treatment
Variation of Shoulder pain and disability index (SPADI) between the 2 groups
SPADI Index is designed to measure current shoulder pain and function of daily tasks in an outpatient setting.
The Shoulder Pain and Disability Index (SPADI) is a self-administered questionnaire that consists of two dimensions, one for pain and the other for functional activities.
The pain dimension consists of five questions regarding the severity of an individual's pain.
Functional activities are assessed with eight questions designed to measure the degree of difficulty an individual has with various activities of daily living that require upper-extremity use. The SPADI takes 5 to 10 minutes for a patient to complete and is the only reliable and valid region-specific measure for the shoulder.
Measured: All visits from baseline to the last follow-up after 12 weeks from the end of the treatment
Single assessment numeric evaluation (SANE)
The Primary Endpoint measure is also the change from baseline of the single assessment numeric evaluation (SANE), which was designed as a simple one-question: "how would you rate your shoulder today as a percentage of normal (0% to 100%, with 100% being normal)?"
Measured: All visits from baseline to the last follow-up after 12 weeks from the end of the treatment
Secondary outcomes (4)
Patient's satisfaction
Patient's satisfaction with the treatment using a 5-points Likert scale (1=very dissatisfied, 2=dissatisfied, 4=neutral, 4=satisfied, 5=highly satisfied). A final score of 2 points or more on the Likert scale at the last clinical investigation visit will be considered clinically significant.
Measured: From the second visit (T1) to last follow-up after 12 weeks from end of treatment
Qualitative description of the ultrasound appearance of the tendon
A qualitative description of the ultrasound appearance of the tendon will be required to compare the final follow-up visit to that of an ultrasound performed at the baseline visit in both groups
Measured: Baseline and last follow-up visit (T4)
Quality of Life using EQ-5D-3L Paper Self-Complete
The EQ-5D-3L descriptive system comprises the following five dimensions, each describing a different aspect of health: MOBILITY, SELF-CARE, USUAL ACTIVITIES, PAIN / DISCOMFORT and ANXIETY / DEPRESSION. Each dimension has three levels: no problems, some problems, extreme problems. The respondent is asked to indicate his / her health state by checking the box against the most appropriate statement in each of the five dimensions. The EQ VAS records the respondent's self-rated health on a vertical VAS where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'. This information can be used as a quantitative measure of health outcome as judged by the individual respondents. The scale used for the answers is the EQ visual analogue scale (EQ VAS). It consists of a vertical 100 point visual analogue scale with two extreme endpoints (0= worst health status; 100=best health status).
Measured: Baseline and at the two follow-up visits (at T3 - 8 weeks after the end of the treatment and T4 - 12 weeks after the end of the treatment)
Adverse events (AE) monitoring
Adverse events (AE) will be monitored throughout the trial. At each scheduled visit, a safety assessment has to be conducted by the investigator. The intensity (mild/moderate/severe) will be assessed according to the investigator's judgement. If a patient drops out of the clinical investigation, the possible reasons for drop-out, including no improvement in the tendinopathy or occurrence of unacceptable signs/symptoms, need to be documented.
Measured: All visits from baseline to the last follow-up after 12 weeks from the end of the treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2025
- Study start10 Dec 2024
- Primary completion14 Apr 2026
- Study completion14 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mastelli S.r.l
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06809543
- Sponsor's protocol ID
- Tropho-Try-2024
- Status last verified
- Sep 2026
- First submitted
- 30 Jan 2025
- Last updated
- 16 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Colangelo MT, Govoni P, Belletti S, Squadrito F, Guizzardi S, Galli C. Polynucleotide biogel enhances tissue repair, matrix deposition and organization. J Biol Regul Homeost Agents. 2021 Jan-Feb;35(1):355-362. doi: 10.23812/20-320-L. No abstract available.
PubMed 33480222Saggini R, Khodor HH, Capogrosso F, Carniel R, Bellomo RG. La condro-sincronizzazione nel danno articolare complesso: risultati della viscosupplementazione con Condrotide. Journal of viscosupplementation.it 2016; 2(1): 1-7.
Saggini R, Di Stefano A, Capogrosso F, Carniel R, Haidar Hassan K, et al. (2014) Viscosupplementation with Hyaluronic Acid or Polynucleotides: Results and Hypothesis for Condro-synchronization. J Clin Trials 4: 198. doi:10.4172/2167-0870.1000198
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Benefits and Safety of Tropho Tend in the Management of Painful Rotator Cuff Tendinopathy (RCT)
- ClinicalTrials.gov ID
- NCT06809543
- Acronym / sponsor ID
- Tropho-Try-2024
- Conditions
- Rotator Cuff Tendinopathy
- Keywords
- Polynucleotides, PN HPT, Mastelli, Rotator cuff tendinopathy, Tendinopathy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Mastelli S.r.lIndustry (pharma, biotech, devices)
- Study start
- 10 Dec 2024 (actual)
- Primary completion
- 14 Apr 2026 (actual)
- Study completion
- 14 Apr 2026 (actual)
- First posted
- 5 Feb 2025 (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.
This is a prospective, open label, controlled, exploratory clinical investigation aimed to evaluate the clinical benefit and safety of Tropho Tend in the conservative management of painful Rotator Cuff Tendinopathy (RCT).
All subjects will be involved in the clinical investigation for 4 months for a total of 5 visits (T0= basal visit, T1, T2, T3, T4).
The control group will be represented by patients diagnosed with rotator cuff tendinopathy treated with rehabilitation physiotherapy (standard of care).
The therapy group will be represented by patients diagnosed with rotator cuff tendinopathy treated with rehabilitation physiotherapy + TrophoTend perilesional injection (TrophoTend will be added on to current standard of care).
All the screened patients at the baseline visit (T0), after checking the inclusion/exclusion criteria, will be prospectively included in the clinical investigation, in a 1:1 randomization. Patients will be randomly assigned to the "control group" (N=30pts), receiving rehabilitation physiotherapy (standard of care), or to the "therapy group" (N=30 pts), receiving Tropho Tend as a add on therapy to the rehabilitation physiotherapy.
Total duration of Clinical Investigation will be 12 months: 2-4 months for patients screening and enrolment; 1 month of therapy administration (3 perilesional injections 2 weeks apart); 3 months of follow-up; 2-4 months for data analysis and final report/paper elaboration.
At the baseline visit (T0), an ultrasound evaluation (EUS) has to be performed to assess tendon condition. If an EUS evaluation performed within one month from T0 is available, this will be considered acceptable. This first evaluation has to be compared with another EUS performed at the final visit to obtain a qualitative description of the ultrasound appearance of the tendon after the treatment.
Patients' enrolment will take 2-4 months. Tropho Tend will be administrated at T0 (basal visit) at T1 (2 weeks) and at T2 (4 weeks) for a total duration of treatment of 1 month.
Follow-up will be performed at T3 (8 weeks) and T4 (12 weeks= 3 months). End of the clinical investigation will be considered the last visit for the last enrolled patient.
A 40% reduction in mean VAS scores between the "Tropho Tend therapy group" and the "control group" is considered as reflecting meaningful clinical improvement for the patient.
At the final visit, the patient has to rate his/her satisfaction with the treatment using a 5-points Likert scale, where 1=very dissatisfied, 2=dissatisfied, 3=neutral, 4=satisfied, 5=highly satisfied.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Therapy group | Experimental | Device: Polynucleotides (Tropho Tend) |
| Control group | Active comparator | Procedure: Rehabilitation physiotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male and female patients ≥ 18 years of age, in good general health condition.
- Painful Rotator Cuff Tendinopathy (RCT) since ≥ 6 weeks.
- Pain and impaired functionality on a 0 to 10 cm-centimeter specifically designed Visual Analogue Scale (VAS) ≥ 4 cm at baseline visit.
- Rotator Cuff Tendinopathy (RCT) diagnosis, based on clinical examination.
- Tendon ultrasound (EUS) performed within one month of enrollment.
Key exclusion criteria (7 listed)
- Treatment with any investigational product within 6 months prior to clinical investigation entry.
- Patients with known hypersensitivity to the products (active compound and excipients) or any component or procedure used in the clinical investigation.
- Patients with para-tendinopathy, partial/total rupture, previous tendon surgery.
- Severe intercurrent illness (e.g.: uncontrolled diabetes mellitus, peripheral neuropathy, autoimmune or inflammatory condition, metabolic disorders, severe oncological conditions) that, in the opinion of the investigator, may put the patient at risk when participating in the clinical investigation or affect the patient's ability to take part in the clinical investigation .
- Patients treated with systemic and/or local steroids within the last 6 months, immunosuppressive drugs within the last 3 months, repeated use of non-steroidal anti-inflammatory drugs (NSAIDs) within the last week or occasional use within 24 hours.
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 |
|---|---|---|
| Polynucleotides (Tropho Tend)Tropho Tend is administered by injecting the solution at level of muscular-tendineal (MJT) or osteo-tendineal junctions (OTJ) using a fine-gauge needle (usually 25-30G). Before injecting the product, the target area will be disinfected with alcohol or another antiseptic, with the antiseptic removed with physiologic sterile solution. Total number of treatments will consist in 3 Tropho Tend administrations: at T0 - basal visit; * T1 - after 2 weeks; * T3 - after 4 weeks. | Device | Therapy group |
| Rehabilitation physiotherapyRehabilitation physiotherapy (standard of care) | Procedure or surgery | Control group |
Primary outcome
Variation of pain and functional impairment
Time frame: All visits from baseline to the last follow-up after 12 weeks from the end of the treatment
The Primary Endpoint measure is the variation of VAS Visual Analogue Scale of pain and of function (VAS; 0-10 cm, where 0= no pain or no function impairment and 10= worse pain or function impairment) in the "Tropho Tend therapy group" compared with the "control group". A 40% reduction in mean VAS scores between the "Tropho Tend therapy group" and the "control group" is considered as reflecting meaningful clinical improvement for the patient.
Variation of Shoulder pain and disability index (SPADI) between the 2 groups
Time frame: All visits from baseline to the last follow-up after 12 weeks from the end of the treatment
SPADI Index is designed to measure current shoulder pain and function of daily tasks in an outpatient setting. The Shoulder Pain and Disability Index (SPADI) is a self-administered questionnaire that consists of two dimensions, one for pain and the other for functional activities. The pain dimension consists of five questions regarding the severity of an individual's pain. Functional activities are assessed with eight questions designed to measure the degree of difficulty an individual has with various activities of daily living that require upper-extremity use. The SPADI takes 5 to 10 minutes for a patient to complete and is the only reliable and valid region-specific measure for the shoulder.
Single assessment numeric evaluation (SANE)
Time frame: All visits from baseline to the last follow-up after 12 weeks from the end of the treatment
The Primary Endpoint measure is also the change from baseline of the single assessment numeric evaluation (SANE), which was designed as a simple one-question: "how would you rate your shoulder today as a percentage of normal (0% to 100%, with 100% being normal)?"
4 secondary outcomes
Patient's satisfaction
Time frame: From the second visit (T1) to last follow-up after 12 weeks from end of treatment
Qualitative description of the ultrasound appearance of the tendon
Time frame: Baseline and last follow-up visit (T4)
Quality of Life using EQ-5D-3L Paper Self-Complete
Time frame: Baseline and at the two follow-up visits (at T3 - 8 weeks after the end of the treatment and T4 - 12 weeks after the end of the treatment)
Adverse events (AE) monitoring
Time frame: All visits from baseline to the last follow-up after 12 weeks from the end of the treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2026.
- Results publication: PubMed 33480222Colangelo MT, Govoni P, Belletti S, Squadrito F, Guizzardi S, Galli C. Polynucleotide biogel enhances tissue repair, matrix deposition and organization. J Biol Regul Homeost Agents. 2021 Jan-Feb;35(1):355-362. doi: 10.23812/20-320-L. No abstract available.
- Results publicationSaggini R, Khodor HH, Capogrosso F, Carniel R, Bellomo RG. La condro-sincronizzazione nel danno articolare complesso: risultati della viscosupplementazione con Condrotide. Journal of viscosupplementation.it 2016; 2(1): 1-7.
- Results publicationSaggini R, Di Stefano A, Capogrosso F, Carniel R, Haidar Hassan K, et al. (2014) Viscosupplementation with Hyaluronic Acid or Polynucleotides: Results and Hypothesis for Condro-synchronization. J Clin Trials 4: 198. doi:10.4172/2167-0870.1000198
- 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 Polynucleotides (Tropho Tend) and Rehabilitation physiotherapy in people with Rotator Cuff Tendinopathy, run by Mastelli S.r.l at 1 site in Italy.
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 7 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 16 Sep 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 Italy. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Variation of pain and functional impairment (time frame: All visits from baseline to the last follow-up after 12 weeks from the end of the treatment). 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 NCT06809543, which also lists 3 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 16 Sep 2026.