Lyophilized Platelet-Rich Plasma Lysate vs Dextrose Prolotherapy for Partial Rotator Cuff Tears
Therapeutic Effect of PRP Lysate and Dextrose Prolotherapy Rotator Cuff Tear
The goal of this clinical trial is to learn whether lyophilized platelet-rich plasma (PRP) lysate can improve shoulder symptoms, shoulder muscle strength, and tendon tear size in adults with partial-thickness rotator cuff tears, compared with hypertonic dextrose prolotherapy.
The main questions this study aims to answer are:
- Does PRP lysate improve shoulder pain and function in people with partial-thickness rotator cuff tears?
- Does PRP lysate improve shoulder internal and external rotation strength?
- Does PRP lysate reduce the size of the rotator cuff tendon tear as measured by ultrasound?
Researchers will compare PRP lysate with hypertonic dextrose prolotherapy to determine whether the changes in shoulder symptoms, muscle strength, and tendon tear size differ between the two treatments.
Participants will be randomly assigned to receive either PRP lysate or hypertonic dextrose. Each participant will receive one ultrasound-guided injection into the partially torn rotator cuff tendon each month for 3 months, for a total of three injections. Participants will complete a questionnaire about shoulder symptoms and function, undergo ultrasound examination of the rotator cuff, and have their shoulder rotation strength measured before the first injection and 1 month after the final injection. Participants assigned to the PRP lysate group will also have blood collected for preparation of the PRP lysate used for their treatment.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
-
-
Taichung, Taiwan
- Taichung Veterans General Hospital
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Beskrivelse
Inclusion Criteria:
- Age older than 20 years.
- Shoulder pain with a partial-thickness rotator cuff tear confirmed by physical examination and ultrasonography.
- Willing and able to provide written informed consent.
Exclusion Criteria:
- Adhesive capsulitis.
- Previous shoulder surgery.
- Neuromuscular disease affecting shoulder strength.
- Platelet dysfunction.
- Thrombocytopenia.
- Hypofibrinogenemia.
- Acute or chronic infectious disease.
- History of chronic liver disease.
- Current antiplatelet therapy.
- Depression or other psychological problems.
- Rheumatological disorders.
- Cognitive impairment that would prevent adherence to the study protocol.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: PRP lysate
Intralesional injection of PRP lysate
|
Intralesional injection of PRP lysate
|
|
Aktiv komparator: Hypertonic dextrose
Intralesional injection of hypertonic dextrose
|
Intralesional injection of hypertonic dextrose
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Sonographic Rotator Cuff Tear Size
Tidsramme: before the first injection and one month after the final injection.
|
Use sono to detect the Rotator cuff tear size
|
before the first injection and one month after the final injection.
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Oxford shoulder score
Tidsramme: Before the first intralesional injection and one month after the final intralesional injection.
|
A 12-item patient-reported instrument that assesses shoulder pain and limitations in daily activities during the previous four weeks.
Each item is rated on a 5-point scale, producing a total score of 12-60; higher scores reflect more severe symptoms and greater impairment in shoulder function.
|
Before the first intralesional injection and one month after the final intralesional injection.
|
|
Shoulder internal and external rotation torque
Tidsramme: before the first injection and one month after the final injection.
|
Utilizing isokinetic dynamometer (Biodex Multi-Joint System 3; Biodex Medical, New York, NY, USA) to measure Shoulder internal and external rotation torque at different angle.
|
before the first injection and one month after the final injection.
|
Samarbeidspartnere og etterforskere
Publikasjoner og nyttige lenker
Generelle publikasjoner
- Lazzarini SG, Buraschi R, Pollet J, Bettariga F, Pancera S, Pedersini P. Effectiveness of Additional or Standalone Corticosteroid Injections Compared to Physical Therapist Interventions in Rotator Cuff Tendinopathy: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. Phys Ther. 2025 Mar 3;105(3):pzaf006. doi: 10.1093/ptj/pzaf006.
- Hopewell S, Keene DJ, Marian IR, Dritsaki M, Heine P, Cureton L, Dutton SJ, Dakin H, Carr A, Hamilton W, Hansen Z, Jaggi A, Littlewood C, Barker KL, Gray A, Lamb SE; GRASP Trial Group. Progressive exercise compared with best practice advice, with or without corticosteroid injection, for the treatment of patients with rotator cuff disorders (GRASP): a multicentre, pragmatic, 2 x 2 factorial, randomised controlled trial. Lancet. 2021 Jul 31;398(10298):416-428. doi: 10.1016/S0140-6736(21)00846-1. Epub 2021 Jul 12.
- Oh LS, Wolf BR, Hall MP, Levy BA, Marx RG. Indications for rotator cuff repair: a systematic review. Clin Orthop Relat Res. 2007 Feb;455:52-63. doi: 10.1097/BLO.0b013e31802fc175.
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- TCVGH-SF21438B
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .