Rotator Cuff Tendinopathy Conservative Treatment With Collagen, PRP or Both

Study Overview
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Brief Summary
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The aim of the trial is comparison of the effectiveness of three methods of conservative treatment in partial thickness rotator cuff injury (PTRCI): collagen with PRP injections, PRP injections alone and collagen injections alone.

Detailed Description
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BACKGROUND: Rotator cuff injury (RCI) occupy third place in the population among the musculoskeletal system pathologies (16%) after low back pain (25%) and knee pain (19%). Partial thickness RCI (PTRCI) is the sum of degenerative, overload and microtrauma processes and their incidence increases significantly with age (up to 30% over 60). One of the factors contributing to the injury is a negative collagen balance and slowed tendon metabolism in proportion to its blood supply disorders. Conservative treatment of PTRCI of degenerative origin is the first choice management, but there are no clear guidelines. External supply of collagen and PRP could potentially counteract these processes. AIM: Comparison of the effectiveness of three treatment concepts: collagen with PRP, PRP alone, collagen alone in the treatment of PTRCI. DESIGN: Randomized prospective trial without blinding SETTING: Open study for outpatients, single center study POPULATION: local population METHODS: Three groups of patients (each group 30 patients) with PTRCI confirmed by ultrasound (N=90). The assessment of the supraspinatus tendon (SSP) in standard position of internal rotation of the upper limb for ultrasound examination, assessment of the thickness of the RC in cross-section (mm). Each group treated by three ultrasound guided injections into the shoulder bursa every consecutive week: Group A - collagen (3 amp Collagen MD Shoulder) together with PRP (2ml); Group B - collagen alone (3 amp Collagen MD Shoulder); Group C - PRP alone. All patients were allowed to continue rehabilitation protocol. Primary control tools: NRS, QuickDash, EQ-5D-5L in control points: IA (initial assessment), 6, 12 and 24 weeks after last injection. Secondary control tools: percentage of patients where the RC continuity were preserved and percentage of patients who had ultrasonographic signs of RC regeneration (crossection width increase, improvement of echogenicity) during the observation period between W0 and 24 weeks.

Official Title
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Collagen and PRP in Partial Thickness Rotator Cuff Injuries: Friends or Only Indifferent Neighbors: Randomized Controlled Trial

Conditions
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Rotator Cuff Tendinosis, Rotator Cuff Tears

Intervention / Treatment
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* Combination Product: Collagen and platelet rich plasma (PRP)
* Combination Product: Collagen
* Combination Product: Platelet rich plasma (PRP)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: clinical signs and symptoms of rotator cuff pathology an adult person consenting to injections partial thickness rotator cuff injury confirmed by ultrasound examination without coexisting severe pathologies (systemic inflammatory disease, malignancy, severe stage OA) no traumatic event no injections or any other local treatment in previous 1 month Exclusion Criteria: full thickness rotator cuff injury acute, traumatic injuries requiring surgical treatment coexisting injuries of the shoulder joint requiring other intervention severe pathologies of the shoulder of another origin (systemic inflammatory disease, malignancy, severe stage OA) no consent

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Collagen and PRP injections<br>Ultrasound guided injections | Combination Product: Collagen and platelet rich plasma (PRP)<br>* Ultrasound guided injections<br>|
| Active Comparator: Collagen injections<br>Ultrasound guided injections | Combination Product: Collagen<br>* Ultrasound guided injections<br>|
| Active Comparator: PRP injections<br>Ultrasound guided injections | Combination Product: Platelet rich plasma (PRP)<br>* Ultrasound guided injections<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in EQ-5D-5L index from baseline to 24 week | EQ-5D-5L index estimated from EQ-5D-5L desrcriptive system based on Polish directly measured value set. Mininmum: -0.590; Maximum: 1.0; More points means better outcome. | Change from baseline to 24 weeks | 
| QuickDASH (Disabilities of Arm, Shoulder and Hand) questionnaire summary score change from baseline to 24 weeks | Range: 0 (the best outcome) - 100 (the worst outcome). | Change from baseline to 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain according to Numeric Rating Scale (NRS) | 0 (no pain) - 10 points (the worst possible pain) | Change from baseline to 6 weeks | 
| Pain according to Numeric Rating Scale (NRS) | 0 (no pain) - 10 points (the worst possible pain) | Change from baseline to 12 weeks | 
| Pain according to Numeric Rating Scale (NRS) | 0 (no pain) - 10 points (the worst possible pain) | Change from baseline to 24 weeks | 
| Width of rotator cuff in ultrasound imaging | Dimensions of cross-section rotator cuff measure in milimeters. | Change from baseline to 24 weeks | 
| Preservation of rotator cuff continuity in ultrasound imaging | Presence / Absence | Change from baseline to 24 weeks | 
| Regenaration of rotator cuff in ultrasound imaging | Presence / Absence | 24 weeks | 
| Change in EQ-5D-5L index from baseline to 6 week | EQ-5D-5L index estimated from EQ-5D-5L desrcriptive system based on Polish directly measured value set. Mininmum: -0.590; Maximum: 1.0; More points means better outcome. | Change from baseline to 6 weeks | 
| Change in EQ-5D-5L index from baseline to 12 week | EQ-5D-5L index estimated from EQ-5D-5L desrcriptive system based on Polish directly measured value set. Mininmum: -0.590; Maximum: 1.0; More points means better outcome. | Change from baseline to 12 weeks | 
| QuickDASH (Disabilities of Arm, Shoulder and Hand) questionnaire summary score change from baseline to 6 weeks | Range: 0 (the best outcome) - 100 (the worst outcome). | Change from baseline to 6 weeks | 
| QuickDASH (Disabilities of Arm, Shoulder and Hand) questionnaire summary score change from baseline to 12 weeks | Range: 0 (the best outcome) - 100 (the worst outcome). | Change from baseline to 12 weeks |