Clinical trial NCT04492748: Rotator Cuff Tendinopathy Conservative Treatment With Collagen, PRP or Both
Official title: Collagen and PRP in Partial Thickness Rotator Cuff Injuries: Friends or Only Indifferent Neighbors: Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Rotator Cuff Tendinosis
Rotator Cuff Tears
Lead sponsor: Sutherland Medical Center
Sponsor class: OTHER
First posted: 2020-07-30
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in EQ-5D-5L index from baseline to 24 week
timeFrame: Change from baseline to 24 weeks
measure: QuickDASH (Disabilities of Arm, Shoulder and Hand) questionnaire summary score change from baseline to 24 weeks
timeFrame: Change from baseline to 24 weeks
Secondary outcomes:
measure: Pain according to Numeric Rating Scale (NRS)
timeFrame: Change from baseline to 6 weeks
measure: Pain according to Numeric Rating Scale (NRS)
timeFrame: Change from baseline to 12 weeks
measure: Pain according to Numeric Rating Scale (NRS)
timeFrame: Change from baseline to 24 weeks
measure: Width of rotator cuff in ultrasound imaging
timeFrame: Change from baseline to 24 weeks
measure: Preservation of rotator cuff continuity in ultrasound imaging
timeFrame: Change from baseline to 24 weeks
measure: Regenaration of rotator cuff in ultrasound imaging
timeFrame: 24 weeks
measure: Change in EQ-5D-5L index from baseline to 6 week
timeFrame: Change from baseline to 6 weeks
measure: Change in EQ-5D-5L index from baseline to 12 week
timeFrame: Change from baseline to 12 weeks
measure: QuickDASH (Disabilities of Arm, Shoulder and Hand) questionnaire summary score change from baseline to 6 weeks
timeFrame: Change from baseline to 6 weeks
measure: QuickDASH (Disabilities of Arm, Shoulder and Hand) questionnaire summary score change from baseline to 12 weeks
timeFrame: Change from baseline to 12 weeks
Other outcomes:
Locations:
city: Warsaw
country: Poland
facility: Sutherland Medical Center
state: Mazowieckie
Study officials:
affiliation: Sutherland Medical Center
name: Piotr Godek, PhD
role: PRINCIPAL_INVESTIGATOR
References: