Rotator Cuff TendinopathyNCT07871318
Nutraceutical Supplementation Combined With Physiotherapy for Rotator Cuff Tendinopathy
A study testing Doltendix® and Exercise-based Physiotherapy in people with Rotator Cuff Tendinopathy, run by Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari at 1 site in Italy.
Trial summary
Rotator cuff tendinopathy is a common cause of shoulder pain and functional impairment. Exercise-based physiotherapy represents a cornerstone of conservative treatment, while nutraceutical supplementation has been proposed as a potential adjunctive strategy. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Rotator Cuff Tendinopathy
- What is being tested?
- Doltendix® and Exercise-based Physiotherapy
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteItaly
- Study dates
- 3 Oct 2024to 5 May 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age between 18 and 60 years.
- Clinical diagnosis of rotator cuff tendinopathy assessed by musculoskeletal ultrasonography, with magnetic resonance imaging performed when clinically required to exclude tendon tears.
- Shoulder pain lasting at least 3 months.
- Visual Analog Scale (VAS) pain score greater than 4 at enrollment.
- Previous physiotherapy for rotator cuff tendinopathy for at least 1 month before enrollment.
Who cannot join
- Partial- or full-thickness rotator cuff tear.
- Other causes of shoulder pain, including acromioclavicular osteoarthritis, adhesive capsulitis, or subacromial bursitis.
- Previous proximal humeral or glenoid fracture.
- Rheumatologic disease.
- Psychiatric disease.
- Cardiovascular disease.
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- Renal or hepatic failure.
- Pregnancy.
- Known hypersensitivity to one or more components of the nutraceutical formulation.
- Treatment with antiepileptic, anticoagulant, antidepressant, or opioid medications.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Nutraceutical Supplementation Combined With Physiotherapy in Patients With Rotator Cuff Tendinopathy: A Prospective Randomized Assessor-Blinded Study
Rotator cuff tendinopathy is a common cause of shoulder pain and functional impairment. Exercise-based physiotherapy represents a cornerstone of conservative treatment, while nutraceutical supplementation has been proposed as a potential adjunctive strategy. This prospective, randomized, assessor-blinded study evaluated the effects of adding a nutraceutical formulation containing bioactive collagen peptides, astaxanthin, trans-resveratrol, and vitamin C (Doltendix®) to physiotherapy in patients with rotator cuff tendinopathy without partial- or full-thickness tendon tears. Forty-two participants were randomly allocated in a 1:1 ratio to physiotherapy plus nutraceutical supplementation or physiotherapy alone. Pain, shoulder function, upper-limb disability, and health-related quality of life were assessed over a 120-day follow-up period
Read the detailed description
This prospective, randomized, parallel-group, assessor-blinded study included adult patients with symptomatic rotator cuff tendinopathy without partial- or full-thickness tendon tears.
Participants were randomly assigned in a 1:1 ratio to an experimental group receiving a standardized physiotherapy program combined with oral nutraceutical supplementation (Doltendix®) or to a control group receiving the same physiotherapy program without nutraceutical supplementation.
The randomization sequence was generated using a web-based randomization tool with permuted random blocks. Allocation was performed after outpatient assessment using a password-protected database. Clinical outcome assessments were performed by a physician independent of the allocation process.
The physiotherapy program lasted 1 month and was intended to improve shoulder strength and range of motion. Participants assigned to the experimental group additionally received Doltendix® for 90 days, administered as two sachets per day for the first 10 days, followed by one sachet per day for the subsequent 80 days.
Clinical outcomes included pain intensity assessed using the Visual Analog Scale (VAS), shoulder function assessed using the University of California, Los Angeles (UCLA) Shoulder Score, upper-limb disability assessed using the Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire, and health-related quality of life assessed using the 12-Item Short Form Health Survey (SF-12). Assessments were performed at recruitment (T1), 30 days (T2), 60 days (T3), 90 days (T4), and 120 days (T5). Adverse events were monitored throughout follow-up
- Conditions
- Rotator Cuff Tendinopathy
- Being tested
- Doltendix®, Exercise-based Physiotherapy
- Keywords
- Rotator cuff tendinopathy, Shoulder pain, Physiotherapy, Nutraceutical supplementation, Collagen peptides, Astaxanthin, Trans-resveratrol
- Medical subject headings
- Shoulder Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Doltendix®Dietary supplement
Also called Nutraceutical supplementation
Oral nutraceutical formulation containing bioactive collagen peptides, astaxanthin, trans-resveratrol, and vitamin C. Participants received two sachets per day after the main meals for the first 10 days, followed by one sachet per day for the subsequent 80 days, for a total supplementation period of 90 days.
Exercise-based PhysiotherapyOther
Participants underwent a 1-month exercise-based physiotherapy program aimed at improving shoulder strength and range of motion. The same physiotherapy program was administered to both treatment groups
| Study group | Role | What they receive |
|---|---|---|
| Physiotherapy Plus Nutraceutical Supplementation | Experimental | Participants received a 1-month physiotherapy program combined with oral Doltendix® supplementation for 90 days. Doltendix® was administered as two sachets per day for the first 10 days, followed by one sachet per day for the subsequent 80 days. Receives: Dietary Supplement: Doltendix®; Other: Exercise-based Physiotherapy |
| Physiotherapy Alone | Active comparator | Participants received the same 1-month physiotherapy program as the experimental group, without nutraceutical supplementation. Receives: Other: Exercise-based Physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Shoulder Pain Intensity Assessed by the Visual Analog Scale (VAS)
Shoulder pain intensity was assessed using a 0-to-10 Visual Analog Scale (VAS), where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate greater pain intensity. Changes in VAS scores were evaluated throughout the 120-day follow-up period.
Measured: Baseline (T1), 30 days (T2), 60 days (T3), 90 days (T4), and 120 days (T5)
Secondary outcomes (3)
Change in Shoulder Function Assessed by the UCLA Shoulder Score
Shoulder function was assessed using the University of California, Los Angeles (UCLA) Shoulder Score, ranging from 0 to 35 points. Higher scores indicate better shoulder function.
Measured: Baseline (T1), 30 days (T2), 60 days (T3), 90 days (T4), and 120 days (T5)
Change in Upper-Limb Disability Assessed by the DASH Questionnaire
Upper-limb disability was assessed using the Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire, with scores ranging from 0 to 100. Higher scores indicate greater disability.
Measured: Baseline (T1), 30 days (T2), 60 days (T3), 90 days (T4), and 120 days (T5)
Change in Health-Related Quality of Life Assessed by the SF-12
Health-related quality of life was assessed using the 12-Item Short Form Health Survey (SF-12). A single overall SF-12 score was used in this study, with higher scores indicating better health-related quality of life.
Measured: Baseline (T1), 30 days (T2), 60 days (T3), 90 days (T4), and 120 days (T5)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2026
- Study start3 Oct 2024
- Primary completion5 May 2025
- Study completion5 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07871318
- Sponsor's protocol ID
- DOLT-RCT-2024-01
- Status last verified
- Oct 2026
- First submitted
- 7 Oct 2026
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data are not planned for public sharing because of participant privacy and the conditions of informed consent. De-identified data may be made available by the corresponding author upon reasonable request, subject to applicable ethical and institutional requirements.
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Nutraceutical Supplementation Combined With Physiotherapy in Patients With Rotator Cuff Tendinopathy: A Prospective Randomized Assessor-Blinded Study
- ClinicalTrials.gov ID
- NCT07871318
- Acronym / sponsor ID
- DOLT-RCT-2024-01
- Conditions
- Rotator Cuff Tendinopathy
- Keywords
- Rotator cuff tendinopathy, Shoulder pain, Physiotherapy, Nutraceutical supplementation, Collagen peptides, Astaxanthin, Trans-resveratrol
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Azienda Ospedaliero-Universitaria Consorziale Policlinico di BariUniversity, hospital or other
- Study start
- 3 Oct 2024 (actual)
- Primary completion
- 5 May 2025 (actual)
- Study completion
- 5 May 2025 (actual)
- First posted
- 13 Oct 2026 (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.
Rotator cuff tendinopathy is a common cause of shoulder pain and functional impairment. Exercise-based physiotherapy represents a cornerstone of conservative treatment, while nutraceutical supplementation has been proposed as a potential adjunctive strategy. This prospective, randomized, assessor-blinded study evaluated the effects of adding a nutraceutical formulation containing bioactive collagen peptides, astaxanthin, trans-resveratrol, and vitamin C (Doltendix®) to physiotherapy in patients with rotator cuff tendinopathy without partial- or full-thickness tendon tears. Forty-two participants were randomly allocated in a 1:1 ratio to physiotherapy plus nutraceutical supplementation or physiotherapy alone. Pain, shoulder function, upper-limb disability, and health-related quality of life were assessed over a 120-day follow-up period
Detailed description
This prospective, randomized, parallel-group, assessor-blinded study included adult patients with symptomatic rotator cuff tendinopathy without partial- or full-thickness tendon tears.
Participants were randomly assigned in a 1:1 ratio to an experimental group receiving a standardized physiotherapy program combined with oral nutraceutical supplementation (Doltendix®) or to a control group receiving the same physiotherapy program without nutraceutical supplementation.
The randomization sequence was generated using a web-based randomization tool with permuted random blocks. Allocation was performed after outpatient assessment using a password-protected database. Clinical outcome assessments were performed by a physician independent of the allocation process.
The physiotherapy program lasted 1 month and was intended to improve shoulder strength and range of motion. Participants assigned to the experimental group additionally received Doltendix® for 90 days, administered as two sachets per day for the first 10 days, followed by one sachet per day for the subsequent 80 days.
Clinical outcomes included pain intensity assessed using the Visual Analog Scale (VAS), shoulder function assessed using the University of California, Los Angeles (UCLA) Shoulder Score, upper-limb disability assessed using the Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire, and health-related quality of life assessed using the 12-Item Short Form Health Survey (SF-12). Assessments were performed at recruitment (T1), 30 days (T2), 60 days (T3), 90 days (T4), and 120 days (T5). Adverse events were monitored throughout follow-up
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Physiotherapy Plus Nutraceutical Supplementation | Experimental | Dietary Supplement: Doltendix®, Other: Exercise-based PhysiotherapyParticipants received a 1-month physiotherapy program combined with oral Doltendix® supplementation for 90 days. Doltendix® was administered as two sachets per day for the first 10 days, followed by one sachet per day for the subsequent 80 days. |
| Physiotherapy Alone | Active comparator | Other: Exercise-based PhysiotherapyParticipants received the same 1-month physiotherapy program as the experimental group, without nutraceutical supplementation. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Age between 18 and 60 years.
- Clinical diagnosis of rotator cuff tendinopathy assessed by musculoskeletal ultrasonography, with magnetic resonance imaging performed when clinically required to exclude tendon tears.
- Shoulder pain lasting at least 3 months.
- Visual Analog Scale (VAS) pain score greater than 4 at enrollment.
- Previous physiotherapy for rotator cuff tendinopathy for at least 1 month before enrollment.
Key exclusion criteria (10 listed)
- Partial- or full-thickness rotator cuff tear.
- Other causes of shoulder pain, including acromioclavicular osteoarthritis, adhesive capsulitis, or subacromial bursitis.
- Previous proximal humeral or glenoid fracture.
- Rheumatologic disease.
- Psychiatric disease.
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 |
|---|---|---|
| Doltendix®Also: Nutraceutical supplementationOral nutraceutical formulation containing bioactive collagen peptides, astaxanthin, trans-resveratrol, and vitamin C. Participants received two sachets per day after the main meals for the first 10 days, followed by one sachet per day for the subsequent 80 days, for a total supplementation period of 90 days. | Dietary supplement | Physiotherapy Plus Nutraceutical Supplementation |
| Exercise-based PhysiotherapyParticipants underwent a 1-month exercise-based physiotherapy program aimed at improving shoulder strength and range of motion. The same physiotherapy program was administered to both treatment groups | Other | Physiotherapy Alone, Physiotherapy Plus Nutraceutical Supplementation |
Primary outcome
Change in Shoulder Pain Intensity Assessed by the Visual Analog Scale (VAS)
Time frame: Baseline (T1), 30 days (T2), 60 days (T3), 90 days (T4), and 120 days (T5)
Shoulder pain intensity was assessed using a 0-to-10 Visual Analog Scale (VAS), where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate greater pain intensity. Changes in VAS scores were evaluated throughout the 120-day follow-up period.
3 secondary outcomes
Change in Shoulder Function Assessed by the UCLA Shoulder Score
Time frame: Baseline (T1), 30 days (T2), 60 days (T3), 90 days (T4), and 120 days (T5)
Change in Upper-Limb Disability Assessed by the DASH Questionnaire
Time frame: Baseline (T1), 30 days (T2), 60 days (T3), 90 days (T4), and 120 days (T5)
Change in Health-Related Quality of Life Assessed by the SF-12
Time frame: Baseline (T1), 30 days (T2), 60 days (T3), 90 days (T4), and 120 days (T5)
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 13 Oct 2026.
- Individual participant dataSharing planned: No. Individual participant data are not planned for public sharing because of participant privacy and the conditions of informed consent. De-identified data may be made available by the corresponding author upon reasonable request, subject to applicable ethical and institutional requirements.
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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 Doltendix® and Exercise-based Physiotherapy in people with Rotator Cuff Tendinopathy, run by Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari 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 5 inclusion and 10 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 13 Oct 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?
Change in Shoulder Pain Intensity Assessed by the Visual Analog Scale (VAS) (time frame: Baseline (T1), 30 days (T2), 60 days (T3), 90 days (T4), and 120 days (T5)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Oct 2026.