Lyophilized Platelet-Rich Plasma Lysate vs Dextrose Prolotherapy for Partial Rotator Cuff Tears

NCT07789951 | Active Not Recruiting

• 1 other identifier: TCVGH-SF21438B
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Rotator Cuff Tear; Rotator Cuff Syndrome; Rotator Cuff Arthropathy of Right Shoulder; Rotator Cuff Arthropathy of Left Shoulder; Rotator Cuff Arthropathy of Bilateral Shoulders

Outcome Measures

Primary Outcomes (1)

• Sonographic Rotator Cuff Tear Size

  Use sono to detect the Rotator cuff tear size

  before the first injection and one month after the final injection.

Secondary Outcomes (2)

• Oxford shoulder score

  Before the first intralesional injection and one month after the final intralesional injection.

• Shoulder internal and external rotation torque

  before the first injection and one month after the final injection.

Study Arms (2)

PRP lysate

EXPERIMENTAL

Intralesional injection of PRP lysate

Drug: PRP lysate

Hypertonic dextrose

ACTIVE COMPARATOR

Intralesional injection of hypertonic dextrose

Drug: Hypertonic dextrose

Interventions

PRP lysate DRUG

Intralesional injection of PRP lysate

PRP lysate

Hypertonic dextrose DRUG

Intralesional injection of hypertonic dextrose

Hypertonic dextrose

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Taichung Veterans General Hospital: lead

Study Sites (1)

Taichung Veterans General Hospital

Taichung, Taiwan

Location

Related Publications (3)

• 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.

  PMID: 39836429 RESULT

• 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.

  PMID: 34265255 RESULT

• 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.

  PMID: 17179786 RESULT

MeSH Terms

Conditions

Rotator Cuff Injuries

Condition Hierarchy (Ancestors)

Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 16, 2026
• First Posted: August 27, 2026
• Study Start: March 11, 2022
• Primary Completion (Estimated): September 17, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: August 27, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)