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Completed
NCT07871318
Nutraceutical Supplementation Combined With Physiotherapy for Rotator Cuff Tendinopathy
Conditions: Rotator Cuff Tendinopathy
Sex: All
Ages: 18 Years – 60 Years
Healthy volunteers: No
Phase: NA
Enrollment: 42
Sponsor: Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari
Location: Policlinico Riuniti di Foggia Foggia Apulia
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. 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
Eligibility Criteria
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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.
* Renal or hepatic failure.
* Pregnancy.
* Known hypersensitivity to one or more components of the nutraceutical formulation.
* Treatment with antiepileptic, anticoagulant, antidepressant, or opioid medications.
Source: ClinicalTrials.gov (NCT07871318). StuddyBuddy aggregates publicly available trial information.