Oral Supplementation Compared With Hyaluronic Acid Infiltration in Rotator Cuff Tendinopathies
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age30-80
SponsorI.R.C.C.S. Fondazione Santa Lucia
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Traumatic shoulder injury as the cause of pain
History of shoulder dislocation, fracture, or previous shoulder surgery
Presence of signs indicating ligamentous instability
Severe shoulder arthrosis, adhesive capsulitis, or calcific tendinitis
Trial design
Design model
Parallel
Treatments tested in this trial
Collagen, Hyaluronic Acid, Vitamin C, and Manganese
Dietary supplementThe Group 1 (G1) will begin taking a dietary supplement the day after enrollment.
Intra-articular infiltration
DrugGroup 2 (G2) will receive three intra-articular injections once per week for 3 weeks, without ultrasound guidance. The route of administration will be intra-articular via the posterior access route.
Treatment groups
50 Participants
are divided into 2 treatment groupsGroup A: Oral supplementionActive comparator 1 intervention
Group B: Intra-articolar infiltrationActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Numeric rating scale (NRS)
Change from baseline NRS at 1 weeks and at 4 weeks and at 8 weeks. NRS is a 10-point scale grading the pain at rest, during movement and during night-time
Time frame
1) (T0 - baseline). 2) Before the first administration of intra-articular HA for Group 2 and at seven days from the initiation of HA-COL for Group 1 (T1, seven days from T0). 3) At seven days foSecondary outcomes
1
Shoulder Disability Questionnaire (SDQ) for shoulder functionality
Change from baseline SDQ at 1 weeks and at 4 weeks and at 8 weeks. The SDQ is a self-assessment scale comprising 22 items designed to gauge functional limitations in daily activities and participation in social engagements among patients with shoulder disorders. Each item requires a YES/NO response, with YES scored as 1. A higher total score (up to 22) indicates greater disability attributed to the shoulder pathology
Time frame
1) (T0 - baseline). 2) Before the first administration of intra-articular HA for Group 2 and at seven days from the initiation of HA-COL for Group 1 (T1, seven days from T0). 3) At seven days foSponsors and contacts
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Source ClinicalTrials.gov