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

NCT04640662 | Completed Phase 1

• 1 other identifier: PV062-2018
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Platelet-rich plasma; Prolotherapy; Biologics; Tendinopathy

Outcome Measures

Primary Outcomes (2)

• Pain Reduction change from baseline

  Visual analog score (VAS) score will be used. The scale is between 0 to 10; 0 is no pain, 10 is the worst pain imaginable

  3 weeks, 6 weeks, 3 months and 6 months

• Functional score change from baseline

  Shoulder Pain and Disability Index (SPADI) questionnaire Two subscales namely pain and disability. Pain scale is from 0 to 10; 0 is no pain, 10 is the worst pain imaginable Disability scale range from 0 to 10; 0 no difficulty, 10 is so difficult it requires help

  3 weeks, 6 weeks, 3 months and 6 months

Secondary Outcomes (4)

• Strength in kg

  3 weeks, 6 weeks, 3 months and 6 months

• Range of Movement

  3 weeks, 6 weeks, 3 months and 6 months

• Peri-scapular Muscle activity

  6 weeks, 3 months and 6 months

• Ultrasound findings The parameters will be on tendon thickness, neo-vascularaization and tear size

  6 weeks, 3 months and 6 months

Study Arms (2)

Platelet-Rich plasma

EXPERIMENTAL

2 ml PRP using commercial kit- YCell Biokit

Biological: Platelet-Rich Plasma; Biological: Prolotherapy

Prolotherapy

ACTIVE COMPARATOR

2 ml 16.5% Dextrose solution

Biological: Platelet-Rich Plasma; Biological: Prolotherapy

Interventions

Platelet-Rich Plasma BIOLOGICAL

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

Also known as: PRP

Platelet-Rich plasma; Prolotherapy

Prolotherapy BIOLOGICAL

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

Also known as: Prolo

Platelet-Rich plasma; Prolotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Chronic shoulder pain more than 3 months
• Diagnosis of supraspinatus tendinopathy by Sports Physician or Orthopaedic
• Diagnosis by ultrasound or MRI

You may not qualify if:

• Patients with the following medical condition: autoimmune rheumatology disease, blood disorder
• Patients with the following shoulder conditions: referred pain from cervical, recent shoulder surgery, shoulder instability, complete rotator cuff tear, adhesive capsulitis
• Patients with the following medications: anti-coagulant treatment, steroid injection in less than 6 months

Sponsors & Collaborators

• University of Malaya: lead

Study Sites (1)

University of Malaya Medical Centre

Petaling Jaya, Kuala Lumpur, 59100, Malaysia

Location

Related Publications (6)

• Lin MT, Chiang CF, Wu CH, Huang YT, Tu YK, Wang TG. Comparative Effectiveness of Injection Therapies in Rotator Cuff Tendinopathy: A Systematic Review, Pairwise and Network Meta-analysis of Randomized Controlled Trials. Arch Phys Med Rehabil. 2019 Feb;100(2):336-349.e15. doi: 10.1016/j.apmr.2018.06.028. Epub 2018 Aug 2.

  PMID: 30076801 BACKGROUND

• 1. Littlewood, C., S. May, and S. Walters, Epidemiology of Rotator Cuff Tendinopathy: A Systematic Review. Shoulder & Elbow, 2013. 5(4): p. 256-265.

  RESULT

• Lewis J, McCreesh K, Roy JS, Ginn K. Rotator Cuff Tendinopathy: Navigating the Diagnosis-Management Conundrum. J Orthop Sports Phys Ther. 2015 Nov;45(11):923-37. doi: 10.2519/jospt.2015.5941. Epub 2015 Sep 21.

  PMID: 26390274 RESULT

• Hurley ET, Hannon CP, Pauzenberger L, Fat DL, Moran CJ, Mullett H. Nonoperative Treatment of Rotator Cuff Disease With Platelet-Rich Plasma: A Systematic Review of Randomized Controlled Trials. Arthroscopy. 2019 May;35(5):1584-1591. doi: 10.1016/j.arthro.2018.10.115. Epub 2019 Apr 15.

  PMID: 31000394 RESULT

• Trebinjac S and Kitchbi. Long-term effect of Prolotherapy on symptomatic rotator cuff tendinopathy. Journal of Health Sciences 2015;5(3):93-98

  RESULT

• Docheva D, Muller SA, Majewski M, Evans CH. Biologics for tendon repair. Adv Drug Deliv Rev. 2015 Apr;84:222-39. doi: 10.1016/j.addr.2014.11.015. Epub 2014 Nov 21.

  PMID: 25446135 RESULT

MeSH Terms

Conditions

Rotator Cuff Injuries; Tendinopathy

Interventions

Prolotherapy

Condition Hierarchy (Ancestors)

Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries; Muscular Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Study Officials

• Samihah A. Karim, MD

  University of Malaya

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: November 11, 2020
• First Posted: November 23, 2020
• Study Start: February 17, 2020
• Primary Completion: June 30, 2021
• Study Completion: September 25, 2021
• Last Updated: November 2, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: after completion in September 2021 to 2025
• Access Criteria: The IPD will be shared with a fellow researcher who interested with the topic. Analysis for systematic review such as the study protocol and the result will be shared through open assess or upon request.

Locations

MY (1)