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Rotator Cuff Tendinopathy Conservative Treatment With Collagen, PRP or Both (RCCT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04492748
Recruitment Status : Unknown
Verified March 2021 by Piotr Godek, Sutherland Medical Center.
Recruitment status was:  Active, not recruiting
First Posted : July 30, 2020
Last Update Posted : March 11, 2021
Sponsor:
Information provided by (Responsible Party):
Piotr Godek, Sutherland Medical Center

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.

Condition or disease Intervention/treatment Phase
Rotator Cuff Tendinosis Rotator Cuff Tears Combination Product: Collagen and platelet rich plasma (PRP) Combination Product: Collagen Combination Product: Platelet rich plasma (PRP) Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Collagen and PRP in Partial Thickness Rotator Cuff Injuries: Friends or Only Indifferent Neighbors: Randomized Controlled Trial
Actual Study Start Date : July 1, 2020
Estimated Primary Completion Date : September 30, 2021
Estimated Study Completion Date : September 30, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Collagen

Arm Intervention/treatment
Experimental: Collagen and PRP injections
Ultrasound guided injections
Combination Product: Collagen and platelet rich plasma (PRP)
Ultrasound guided injections

Active Comparator: Collagen injections
Ultrasound guided injections
Combination Product: Collagen
Ultrasound guided injections

Active Comparator: PRP injections
Ultrasound guided injections
Combination Product: Platelet rich plasma (PRP)
Ultrasound guided injections




Primary Outcome Measures :
  1. Change in EQ-5D-5L index from baseline to 24 week [ Time Frame: 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.

  2. QuickDASH (Disabilities of Arm, Shoulder and Hand) questionnaire summary score change from baseline to 24 weeks [ Time Frame: Change from baseline to 24 weeks ]
    Range: 0 (the best outcome) - 100 (the worst outcome).


Secondary Outcome Measures :
  1. Pain according to Numeric Rating Scale (NRS) [ Time Frame: Change from baseline to 6 weeks ]
    0 (no pain) - 10 points (the worst possible pain)

  2. Pain according to Numeric Rating Scale (NRS) [ Time Frame: Change from baseline to 12 weeks ]
    0 (no pain) - 10 points (the worst possible pain)

  3. Pain according to Numeric Rating Scale (NRS) [ Time Frame: Change from baseline to 24 weeks ]
    0 (no pain) - 10 points (the worst possible pain)

  4. Width of rotator cuff in ultrasound imaging [ Time Frame: Change from baseline to 24 weeks ]
    Dimensions of cross-section rotator cuff measure in milimeters.

  5. Preservation of rotator cuff continuity in ultrasound imaging [ Time Frame: Change from baseline to 24 weeks ]
    Presence / Absence

  6. Regenaration of rotator cuff in ultrasound imaging [ Time Frame: 24 weeks ]
    Presence / Absence

  7. Change in EQ-5D-5L index from baseline to 6 week [ Time Frame: 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.

  8. Change in EQ-5D-5L index from baseline to 12 week [ Time Frame: 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.

  9. QuickDASH (Disabilities of Arm, Shoulder and Hand) questionnaire summary score change from baseline to 6 weeks [ Time Frame: Change from baseline to 6 weeks ]
    Range: 0 (the best outcome) - 100 (the worst outcome).

  10. QuickDASH (Disabilities of Arm, Shoulder and Hand) questionnaire summary score change from baseline to 12 weeks [ Time Frame: Change from baseline to 12 weeks ]
    Range: 0 (the best outcome) - 100 (the worst outcome).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04492748


Locations
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Poland
Sutherland Medical Center
Warsaw, Mazowieckie, Poland, 04-036
Sponsors and Collaborators
Sutherland Medical Center
Investigators
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Principal Investigator: Piotr Godek, PhD Sutherland Medical Center
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Responsible Party: Piotr Godek, Principal Investigator, Sutherland Medical Center
ClinicalTrials.gov Identifier: NCT04492748    
Other Study ID Numbers: SMC2020001
First Posted: July 30, 2020    Key Record Dates
Last Update Posted: March 11, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Tendinopathy
Rotator Cuff Injuries
Rupture
Wounds and Injuries
Shoulder Injuries
Tendon Injuries
Muscular Diseases
Musculoskeletal Diseases