Rotator Cuff Tendinosis, Rotator Cuff Tears
Conditions
Brief summary
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
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.
Interventions
COMBINATION_PRODUCTCollagen and platelet rich plasma (PRP)
Ultrasound guided injections
COMBINATION_PRODUCTCollagen
Ultrasound guided injections
COMBINATION_PRODUCTPlatelet rich plasma (PRP)
Ultrasound guided injections
Sponsors
Sutherland Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in EQ-5D-5L index from baseline to 24 week | Change from baseline to 24 weeks | 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. |
| QuickDASH (Disabilities of Arm, Shoulder and Hand) questionnaire summary score change from baseline to 24 weeks | Change from baseline to 24 weeks | Range: 0 (the best outcome) - 100 (the worst outcome). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Width of rotator cuff in ultrasound imaging | Change from baseline to 24 weeks | Dimensions of cross-section rotator cuff measure in milimeters. |
| Preservation of rotator cuff continuity in ultrasound imaging | Change from baseline to 24 weeks | Presence / Absence |
| Regenaration of rotator cuff in ultrasound imaging | 24 weeks | Presence / Absence |
| Change in EQ-5D-5L index from baseline to 6 week | Change from baseline to 6 weeks | 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. |
| QuickDASH (Disabilities of Arm, Shoulder and Hand) questionnaire summary score change from baseline to 6 weeks | Change from baseline to 6 weeks | Range: 0 (the best outcome) - 100 (the worst outcome). |
| QuickDASH (Disabilities of Arm, Shoulder and Hand) questionnaire summary score change from baseline to 12 weeks | Change from baseline to 12 weeks | Range: 0 (the best outcome) - 100 (the worst outcome). |
| Change in EQ-5D-5L index from baseline to 12 week | Change from baseline to 12 weeks | 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. |
| Pain according to Numeric Rating Scale (NRS) | Change from baseline to 6 weeks | 0 (no pain) - 10 points (the worst possible pain) |
Countries
Poland
Outcome results
None listed