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OpenTrials
Active, not recruiting

NCT Number: NCT07789951

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

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.

Active, not recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Taichung Veterans General Hospital

Taichung, Taiwan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

PRP lysate

Drug

Intralesional injection of PRP lysate

Hypertonic dextrose

Drug

Intralesional injection of hypertonic dextrose

Primary outcomes

  1. Sonographic Rotator Cuff Tear Size

    Time frame: before the first injection and one month after the final injection.

    Use sono to detect the Rotator cuff tear size

Secondary outcomes

  1. Oxford shoulder score

    Time frame: 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.

  2. Shoulder internal and external rotation torque

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Taichung Veterans General Hospital

Other

Registry information

Official study title

Therapeutic Effect of PRP Lysate and Dextrose Prolotherapy Rotator Cuff Tear

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Aug 27, 2026
Registry last updated
Aug 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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