Actively Recruiting

Phase Not Applicable
Age: 30Years - 80Years
All Genders
ID06379997

Efficacy of Oral Hyaluronic Acid and Collagen Supplementation Compared With Hyaluronic Acid Infiltration Treatment in Rotator Cuff Tendinopathies: A Prospective Study

Led by I.R.C.C.S. Fondazione Santa Lucia · Updated on 2024-08-29

50

Participants Needed

1

Research Sites

8 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are investigating the effectiveness of an oral supplement containing Collagen, Hyaluronic Acid, Vitamin C, and Manganese compared to intra-articular hyaluronic acid injections for adults with shoulder rotator cuff tendinopathy. This condition causes shoulder pain and functional impairment, often due to degenerative changes in tendon structure. The study aims to see if the oral supplement can reduce pain and improve shoulder function as well as the injected treatment. The study includes 50 adults with persistent shoulder pain and imaging evidence of rotator cuff tendinopathy. All participants receive one corticosteroid injection (triamcinolone acetonide 40 mg). They are then randomly assigned to either take one vial per day of the oral supplement for 56 days or receive three weekly intra-articular injections of hyaluronic acid. The oral supplement group starts the treatment the day after enrollment, while the injection group receives treatments without ultrasound guidance. Participants will be assessed at four time points: before corticosteroid injection (baseline), seven days after starting oral supplementation or before the first hyaluronic acid injection, mid-cycle of oral treatment or seven days after the last injection, and at the end of the 56-day oral cycle or 28 days after the last injection. Pain is measured using the Numeric Rating Scale (NRS) for pain at rest, during movement, and at night. Shoulder function is evaluated with the Shoulder Disability Questionnaire (SDQ). Safety and side effects will be recorded throughout the study.

CONDITIONS

Brief Title

Oral Supplementation Compared With Hyaluronic Acid Infiltration in Rotator Cuff Tendinopathies

Who Can Participate

Age: 30Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Persistent shoulder pain lasting for at least 2 months unresponsive to nonsteroidal anti-inflammatory drugs and rehabilitation
  • Ultrasound or MRI evidence of a rotator cuff lesion without complete tendon rupture
  • Limited active range of motion in the shoulder
  • Age between 30 and 80 years
  • Willingness to provide informed consent to participate in the study
Not Eligible

You will not qualify if you...

  • Traumatic shoulder injury as the cause of pain
  • History of shoulder dislocation, fracture, or previous shoulder surgery
  • Signs indicating ligamentous instability
  • Severe shoulder arthrosis, adhesive capsulitis, or calcific tendinitis
  • Previous infiltrative treatment with corticosteroids, hyaluronic acid, or collagen within the past 6 months
  • Diagnosis of rheumatic or neoplastic diseases
  • Ongoing therapy with anticoagulants
  • Cervical radiculopathy
  • Pregnancy
  • History of heart, kidney, or liver failure
  • Cognitive impairment

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Up to 8 weeks

Participants receive either daily oral supplementation with Collagen, Hyaluronic Acid, Vitamin C, and Manganese for 56 days, or three weekly intra-articular hyaluronic acid injections over 3 weeks.

3 weekly visits for injections or daily oral supplement intake with follow-up assessments

Trial Site Locations

Total: 1 location

1

I.R.C.C.S. Fondazione Santa Lucia

Roma, RM, Italy, 00179

Actively Recruiting

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Research Team

S

Stefano Brunelli, MD

N

Noemi Gentileschi, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

Efficacy and safety of corticosteroid injections and other injections for management of tendinopathy: a systematic review of randomised controlled trials.

Brooke K Coombes, Leanne Bisset, Bill Vicenzino

https://pubmed.ncbi.nlm.nih.gov/20970844

Effectiveness of hyaluronic acid administration in treating adhesive capsulitis of the shoulder: a systematic review of randomized controlled trials.

Lin-Chien Lee, Fu-Kong Lieu, Hung-Lin Lee...

https://pubmed.ncbi.nlm.nih.gov/25802845