The Effects of Platelet-Rich Plasma Versus Prolotherapy On Rotator Cuff Tendinopathy: A Randomized Controlled Trial.
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.
Timeline
- Start
- 2020-02-17
- Primary completion
- 2021-06-30
- Completion
- 2021-09-25
Publications
- Background 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.
- Results 1. Littlewood, C., S. May, and S. Walters, Epidemiology of Rotator Cuff Tendinopathy: A Systematic Review. Shoulder & Elbow, 2013. 5(4): p. 256-265.
- Results 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.
- Results 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.
- Results Trebinjac S and Kitchbi. Long-term effect of Prolotherapy on symptomatic rotator cuff tendinopathy. Journal of Health Sciences 2015;5(3):93-98
- Results 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Dextrose | Unknown | 2 ml | Other |
| Subject | Dextrose | Unknown | 16.5 % | Other |
| Subject | Platelet Rich Plasma | Other / unclassified | 2 ml | Other |