Rotator Cuff Tendinopathy Conservative Treatment With Collagen, PRP or Both

Rotator Cuff Tears Clinical Trial

— RCCT  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04492748
• Other study ID #: SMC2020001
• Status: Active, not recruiting
• Phase: Phase 4
• Start date: July 1, 2020
• Est. completion date: September 30, 2021

Study information

• Verified date: March 2021
• Source: Sutherland Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 90
• Est. completion date: September 30, 2021
• Est. primary completion date: September 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Rotator Cuff Injuries
• Rotator Cuff Tears
• Rotator Cuff Tendinosis
• Tendinopathy

Intervention

Combination Product:
• Collagen and platelet rich plasma (PRP)
Ultrasound guided injections
• Collagen
Ultrasound guided injections
• Platelet rich plasma (PRP)
Ultrasound guided injections

Locations

Country	Name	City	State
Poland	Sutherland Medical Center	Warsaw	Mazowieckie

Sponsors (1)

Lead Sponsor	Collaborator
Sutherland Medical Center

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Pain according to Numeric Rating Scale (NRS)	0 (no pain) - 10 points (the worst possible pain)	Change from baseline to 6 weeks
Secondary	Pain according to Numeric Rating Scale (NRS)	0 (no pain) - 10 points (the worst possible pain)	Change from baseline to 12 weeks
Secondary	Pain according to Numeric Rating Scale (NRS)	0 (no pain) - 10 points (the worst possible pain)	Change from baseline to 24 weeks
Secondary	Width of rotator cuff in ultrasound imaging	Dimensions of cross-section rotator cuff measure in milimeters.	Change from baseline to 24 weeks
Secondary	Preservation of rotator cuff continuity in ultrasound imaging	Presence / Absence	Change from baseline to 24 weeks
Secondary	Regenaration of rotator cuff in ultrasound imaging	Presence / Absence	24 weeks
Secondary	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
Secondary	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
Secondary	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
Secondary	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