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The Effects of Platelet-Rich Plasma Versus Prolotherapy On Rotator Cuff Tendinopathy: A Randomized Controlled Trial.

NCT04640662 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2022-11-02

No results posted yet for this study

Summary

Rotator cuff tendinopathy is the common cause of shoulder pain in the working-age group and the elderly (1). The condition reported takes an average of 10 months or longer to recover. Treatment ranges from non-surgical therapy through exercise, physiotherapy, injections to surgery (2). Injection of steroid was used in many cases to reduce pain. However, steroid only provided short term pain relief and did not resolve the main pathology. Emerging of biologics agents such as platelet-rich plasma (PRP) and prolotherapy are alternative to the treatment (3). PRP is a concentrated platelet which contains a high concentration of protein that helps in the healing process (4). Prolotherapy with the commonly used substance dextrose works by attracting inflammatory substrate and stimulate own body healing process (5).

This study takes place at the University of Malaya Medical Centre. Participants diagnosed with rotator cuff tendinopathy are randomly divided into two groups- Platelet Rich Plasma (PRP) group and Prolotherapy group. All participants are screened by the researcher for the eligibility to join the study. Subsequently, the participants undergo baseline assessment on the clinical, functional, biomechanics and ultrasound. Blood is taken in all patient, to make the patient blind to the intervention they received. In the PRP group- the participants received 2ml of PRP, and in prolotherapy group, the participants received 2ml of 16.5% dextrose solution. A single injection is done by an experienced Sports Physician using ultrasound-guided into the injured area. The assessor at baseline, and follow up are blinded to the intervention. The participants need to come for follow up at 3 weeks, 6 weeks, 3 months and 6 months after injection.

Systematic reviews showed the benefit of biologics agent to treat tendon injuries, especially for lateral epicondylitis and patellar tendinitis (6). Many studies for soft tissue injury were on PRP compared to prolotherapy. This study hypothesized that both treatments result in significant improvement in pain and function after the intervention. PRP might provide more significant improvement compared to prolotherapy.

Conditions

  • Rotator Cuff Tendinosis
  • Supraspinatus Strain
  • PRP

Interventions

BIOLOGICAL

Platelet-Rich Plasma

Single-injection of 2 ml PRP into the lesion under ultrasound-guided

BIOLOGICAL

Prolotherapy

Single-injection of 2ml dextrose 16.5% into the lesion under ultrasound-guided

Sponsors & Collaborators

  • University of Malaya

    lead OTHER

Principal Investigators

  • Samihah A. Karim, MD · University of Malaya

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-02-17
Primary Completion
2021-06-30
Completion
2021-09-25

Countries

  • Malaysia

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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 NCT04640662 on ClinicalTrials.gov