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

Status: Recruiting
Location: See location...
Intervention Type: Dietary supplement, Drug
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The present study aims to investigate the effectiveness of oral supplementation with a nutraceutical containing Collagen, Hyaluronic Acid, Vitamin C, and Manganese in functional outcome and pain reduction in cases of shoulder rotator cuff tendinopathy compared to a cycle of intra-articular hyaluronic acid injections. The project involves the recruitment of 50 adult individuals presenting with shoulder pain and instrumental evidence of rotator cuff tendinopathy. All participants will receive one intra-articular injection of 1 ml of triamcinolone acetonide 40 mg. After the injection, participants will be divided into two groups according to Good Clinical Practice guidelines. One group will begin taking one vial per day for 56 days of an oral supplement containing Hyaluronic Acid, Collagen, Vitamin C, and Manganese (HA-COL) (Tendogenial®, B2Pharma) starting from the day following enrollment (Group 1). The other group will undergo a cycle of 3 intra-articular injections with hyaluronic acid (HA) (Hyalotend®, Fidia) (Group 2). The hypothesis is that oral supplementation with HA-COL may have the same efficacy as intra-articular hyaluronic acid treatment in reducing pain and improving shoulder functionality. Functional assessments will be conducted by a clinician unaware of the participants' group assignment. The following assessment scales will be used: Numeric Rating Scale (NRS) for pain (from 0 to 10), evaluating 3 aspects of pain: 1) pain at rest, 2) nocturnal pain, 3) pain during movement. Shoulder Disability Questionnaire (SDQ) for functionality. Assessments will be conducted at the following time points: T0) Before the administration of corticosteroid intra-articular injection (baseline). T1) Seven days after the start of HA-COL intake for Group 1 and before the first intra-articular HA injection for Group 2 (T1, seven days from T0). T2) At mid-cycle of oral HA-COL supplementation for Group 1 (28 days of intake) and seven days after the last HA injection for Group 2 (T2, 21 days from T1). T3) Follow-up at 28 days from T2, at the end of the 56-day oral treatment cycle for Group 1, and 28 days after the last injection for Group 2 (T3, 56 days from T0).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 30
Maximum Age: 80
Healthy Volunteers: f
View:

• Persistent shoulder pain lasting for at least 2 months unresponsive to conservative treatment (nonsteroidal anti-inflammatory drugs \[NSAIDs\] and rehabilitation)

• Ultrasound or MRI evidence of a rotator cuff lesion without complete tendon rupture

• Limited active range of motion (ROM) in the shoulder

Locations
Other Locations
Italy
I.R.C.C.S. Fondazione Santa Lucia
RECRUITING
Roma
Contact Information
Primary
Stefano Brunelli, MD
s.brunelli@hsantalucia.it
0651501844
Backup
Noemi Gentileschi, MD
n.gentileschi@hsantalucia.it
0651501845
Time Frame
Start Date: 2024-08-10
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 50
Treatments
Active_comparator: Oral supplemention
Assumption of 1 vial/day starting from the day after enrollment for 56 days. This supplement contains Collagen, Hyaluronic Acid, Vitamin C, and Manganese.
Active_comparator: Intra-articolar infiltration
Intra-articular injections of a viscous solution of sodium salt hyaluronic acid (500-730 kDa) in pre-filled 20 mg/2 ml syringes, 1/week for 3 weeks.
Related Therapeutic Areas
Sponsors
Leads: I.R.C.C.S. Fondazione Santa Lucia

This content was sourced from clinicaltrials.gov