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The Clinical and Biological Effect of ESWT With Combined PRP Therapy on Rotator Cuff Lesions

NCT05032924 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2021-09-02

No results posted yet for this study

Summary

Through the investigators previous study of the effect of transient increased cellular permeability after ESWT, combined ESWT and PRP may have better effect on the treatment of rotator cuff lesions. The investigators intend to conduct a prospective double blind randomized control study on the treatment effect of combined ESWT and PRP therapy for rotator cuff lesions without complete tearing. Constant Score, VAS and data from peripheral blood will be measured for the effectiveness evaluation. Shoulder MRI will be followed-up one year after ESWT. The investigators hypothesize that combined ESWT and PRP will be more effective for rotator cuff lesions.

Conditions

  • Rotator Cuff Lesions

Interventions

COMBINATION_PRODUCT

PPR group with ESWT

extracorporeal shock wave (ESWT) (STORZ MEDICAL Extracorporeal Shock Wave Therapy) (3000 impulse, each point, 24 KV, 0.32 mJ/mm2) one week after PRP or HA injection

COMBINATION_PRODUCT

PPR group without ESWT

PRP or HA injection only

COMBINATION_PRODUCT

HA group with ESWT

extracorporeal shock wave (ESWT) (STORZ MEDICAL Extracorporeal Shock Wave Therapy)

COMBINATION_PRODUCT

HA group without ESWT

PRP or HA injection only

Sponsors & Collaborators

  • Chang Gung Memorial Hospital

    lead OTHER

Principal Investigators

  • Jih-Yang Ko, MD · Chang Gung Memorial Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
35 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-08-02
Primary Completion
2024-07-31
Completion
2024-07-31

Countries

  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05032924 on ClinicalTrials.gov