An interventional study of Doltendix® and Exercise-based Physiotherapy in Rotator Cuff Tendinopathy, sponsored by Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari. Completed at 1 site in Italy. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-10-13.
Sponsored by Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari · Not applicable, Interventional, and Treatment
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
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
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This study's enrollment of 42 is below the median of 60 across 577 interventional studies indexed under Shoulder Pain.
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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.
Dietary Supplement: Doltendix® · Other: Exercise-based Physiotherapy
Participants received the same 1-month physiotherapy program as the experimental group, without nutraceutical supplementation.
Other: Exercise-based Physiotherapy
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.
Also known as: Nutraceutical supplementation
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
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.
Time frame: Baseline (T1), 30 days (T2), 60 days (T3), 90 days (T4), and 120 days (T5)
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.
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
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.
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
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.
Time frame: Baseline (T1), 30 days (T2), 60 days (T3), 90 days (T4), and 120 days (T5)
Plan to share: 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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Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari