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February 9, 2021

CGS J15 Contractor Advisory Committee (CAC) Meeting Regarding Platelet Rich Plasma for Non-Wound Care – Questions

Voting Questions:

For each voting question, please use the following scale identifying your level of confidence - with a score of 1 being low or no confidence and 5 representing high confidence.

1 Low Confidence 2 3 Intermediate 4 5 High Confidence

Using this scale, please rate your confidence in the clinical literature for each question and cite the literature and rationale for your score. A score of ≥ 2.5 is considered intermediate confidence that there is robust clinical literature to support the question.

  1. How do you rate the quality of evidence for safety of platelet rich plasma (PRP) into joints/tissues for non-wound conditions?
    1. Is there evidence to demonstrate long term safety?
    2. Is there evidence of safety of repeat injections into same joint? If so, how many injections?
    3. Is there evidence of safety as compared to current standard of care treatments (steroids/anesthetics)?
  2. How do you rate the quality of evidence for efficacy of platelet rich plasma into joints/tissues for non-wound conditions?
    1. Is there evidence to demonstrate short term vs. long term benefit?
    2. Is there evidence that repeat injections into same joint improve efficacy? If so, how many injections?
    3. Is there evidence of effectiveness as compared to current standard of care treatments (steroids/anesthetics/others)?
  3. Is there evidence based standardized protocols that provide standard practice for these injections? This would address issues such as patient selection, preparation protocol, concentration of platelets injected, frozen vs. fresh, combining PRP with other agents, contraindications, numbers of injections and duration between injections, pre-procedure preparation (like avoiding NSAIDS before injections), use of local anesthetics at time of injections, post-procedure exercise plans, and image guidance at time of injections? If yes, what protocols? Please provide citations.
  4. Please rate the evidence for both safety and efficacy for the following conditions using scale of 1-5.

    Condition Safety Efficacy
    Osteoarthritis of the knee    
    Plantar fasciitis    
    Anchilles tendopathy    
    Patellar tendopathy    
    Lateral epicondylitis    
    Carpal tunnel syndrome    
    Rotator cuff tears    
    Chronic low back pain    

Bibliography

Guidelines

Chu CR, Rodeo S, Bhutani N, et al. Optimizing Clinical Use of Biologics in Orthopaedic Surgery: Consensus Recommendations From the 2018 AAOS/NIH U-13 Conference. J Am Acad Orthop Surg. 2019;27(2):e50-e63.

Navani A, Manchikanti L, Albers SL, et al. Responsible, Safe, and Effective Use of Biologics in the Management of Low Back Pain: American Society of Interventional Pain Physicians (ASIPP) Guidelines. Pain Physician. 2019;22(1s):S1-s74.

National Institute of Health and Care Excellence (NICE). Platelet-rich plasma injections for knee osteoarthritis. Published date: 23 January 2019 https://www.nice.org.uk/guidance/ipg637/chapter/2-The-condition-current-treatments-and-procedureExternal Website

American Association of Hip and Knee Surgeons (AAHKS). Biologics for Advanced Hip and Knee Arthritis. Position of the American Association of Hip and Knee Surgeons 2019 Jun.

American College of Rheumatology. 2019 American College of Rheumatology/Arthritis Foundation Guideline for the Management of Osteoarthritis of the Hand, Hip and Knee. 2019.

Department of Veterans Affairs. Department of Depense. (Va/DoD). VA/DoD Clinical practice Guidelines for the non-surgical management of hip & knee osteoarthritis. 2020

Osteoarthritis Research Society of International (OARSI). OARSI guidelines for the non-surgical management of knee, hip, and polyarticular osteoarthrosis. 2019

Royal Australian College of General Practitioners (RACGP). Guideline for the management of knee and hip osteoarthritis. Jul 2018.

Hashimoto R, Skelly AC, Brodt E et al. Autologous Blood or Platelet-Rich Plasma Injections. Health Technology Assessment Program. 2016 https://www.hca.wa.gov/assets/prp_final_rpt_041516.pdf

General

Moraes VY, Lenza M, Tamaoki MJ, Faloppa F, Belloti JC. Platelet-rich therapies for musculoskeletal soft tissue injuries. The Cochrane database of systematic reviews. 2013(12):Cd010071.

Tendinopathies

Andia I, Maffulli N. Muscle and tendon injuries: the role of biological interventions to promote and assist healing and recovery. Arthroscopy. 2015;31(5):999-1015.

Schippinger G, Prüller F, Divjak M, et al. Autologous Platelet-Rich Plasma Preparations: Influence of Nonsteroidal Anti-inflammatory Drugs on Platelet Function. Orthop J Sports Med. 2015;3(6):2325967115588896.

Kampa RJ, Connell DA. Treatment of tendinopathy: is there a role for autologous whole blood and platelet rich plasma injection? International journal of clinical practice. 2010;64(13):1813-1823.

Fitzpatrick J, Bulsara M, Zheng MH. The Effectiveness of Platelet-Rich Plasma in the Treatment of Tendinopathy: A Meta-analysis of Randomized Controlled Clinical Trials. Am J Sports Med. 2017;45(1):226233.

Lateral epicondylitis

Mishra AK, Skrepnik NV, Edwards SG, et al. Efficacy of platelet-rich plasma for chronic tennis elbow: a double- blind, prospective, multicenter, randomized controlled trial of 230 patients. Am J Sports Med. 2014;42(2):463 471. Med. 2011;39(6):1200-1208.

Krogh TP, Fredberg U, Stengaard-Pedersen K, Christensen R, Jensen P, Ellingsen T. Treatment of lateral epicondylitis with platelet-rich plasma, glucocorticoid, or saline: a randomized, double-blind, placebo- controlled trial. Am J Sports Med. 2013;41(3):625-635.

Gautam VK, Verma S, Batra S, Bhatnagar N, Arora S. Platelet-rich plasma versus corticosteroid injection for recalcitrant lateral epicondylitis: clinical and ultrasonographic evaluation. Journal of orthopaedic surgery (Hong Kong). 2015;23(1):1-5.

Lebiedzinski R, Synder M, Buchcic P, Polguj M, Grzegorzewski A, Sibinski M. A randomized study of autologous conditioned plasma and steroid injections in the treatment of lateral epicondylitis. International orthopaedics. 2015;39(11):2199-2203.

Hastie G, Soufi M, Wilson J, Roy B. Platelet rich plasma injections for lateral epicondylitis of the elbow reduce the need for surgical intervention. J Orthop. 2018;15(1):239-241.

Mi B, Liu G, Zhou W, et al. Platelet rich plasma versus steroid on lateral epicondylitis: meta-analysis of randomized clinical trials. The Physician and sportsmedicine. 2017;45(2):97-104.

Montalvan B, Le Goux P, Klouche S, Borgel D, Hardy P, Breban M. Inefficacy of ultrasound-guided local injections of autologous conditioned plasma for recent epicondylitis: results of a double-blind placebo-controlled randomized clinical trial with one-year follow-up. Rheumatology (Oxford, England). 2016;55(2):279285.

Schöffl V, Willauschus W, Sauer F, et al. Autologous Conditioned Plasma Versus Placebo Injection Therapy in Lateral Epicondylitis of the Elbow: A Double Blind, Randomized Study. Sportverletzung Sportschaden : Organ der Gesellschaft fur Orthopadisch-Traumatologische Sportmedizin. 2017;31(1):31-36.

Linnanmaki L, Kanto K, Karjalainen T, Leppanen OV, Lehtinen J. Platelet-rich Plasma or Autologous Blood Do Not Reduce Pain or Improve Function in Patients with Lateral Epicondylitis: A Randomized Controlled Trial. Clin Orthop Relat Res. 2020.

Peerbooms JC, Sluimer J, Bruijn DJ, Gosens T. Positive effect of an autologous platelet concentrate in lateral epicondylitis in a double-blind randomized controlled trial: platelet-rich plasma versus corticosteroid injection with a 1-year follow-up. Am J Sports Med. 2010;38(2):255-262.

Carpal Tunnel Syndrome

Lin CP, Chang KV, Huang YK, Wu WT, Ozcakar L. Regenerative Injections Including 5% Dextrose and Platelet-Rich Plasma for the Treatment of Carpal Tunnel Syndrome: A Systematic Review and Network Meta-Analysis. Pharmaceuticals (Basel). 2020;13(3).

Rotator Cuff Tears

Kesikburun S, Tan AK, Yilmaz B, Yasar E, Yazicioglu K. Platelet-rich plasma injections in the treatment of chronic rotator cuff tendinopathy: a randomized controlled trial with 1-year follow-up. Am J Sports Med. 2013;41(11):2609-2616.

Rha DW, Park GY, Kim YK, Kim MT, Lee SC. Comparison of the therapeutic effects of ultrasound-guided platelet-rich plasma injection and dry needling in rotator cuff disease: a randomized controlled trial. Clinical rehabilitation. 2013;27(2):113-122.

Singh P, Madanipour S, Bhamra JS, Gill I. A systematic review and meta-analysis of platelet-rich plasma versus corticosteroid injections for plantar fasciopathy. International orthopaedics. 2017;41(6):1169-1181.

Chen X, Jones IA, Togashi R, Park C, Vangsness CT, Jr. Use of Platelet-Rich Plasma for the Improvement of Pain and Function in Rotator Cuff Tears: A Systematic Review and Meta-analysis With Bias Assessment. Am J Sports Med. 2019:363546519881423.

Plantar Fasciitis

Singh P, Madanipour S, Bhamra JS, Gill I. A systematic review and meta-analysis of platelet-rich plasma versus corticosteroid injections for plantar fasciopathy. International orthopaedics. 2017;41(6):1169-1181.

Johnson-Lynn S, Cooney A, Ferguson D, et al. A Feasibility Study Comparing Platelet-Rich Plasma Injection With Saline for the Treatment of Plantar Fasciitis Using a Prospective, Randomized Trial Design. Foot & ankle specialist. 2019;12(2):153-158.

Peerbooms JC, Lodder P, den Oudsten BL, Doorgeest K, Schuller HM, Gosens T. Positive Effect of Platelet-Rich Plasma on Pain in Plantar Fasciitis: A Double-Blind Multicenter Randomized Controlled Trial. Am J Sports Med. 2019;47(13):3238-3246 .

Achilles tendinopathy

Krogh TP, Ellingsen T, Christensen R, Jensen P, Fredberg U. Ultrasound-Guided Injection Therapy of Achilles Tendinopathy With Platelet-Rich Plasma or Saline: A Randomized, Blinded, Placebo-Controlled Trial. Am J Sports Med. 2016;44(8):1990-1997 .

de Jonge S, de Vos RJ, Weir A, et al. One-year follow-up of platelet-rich plasma treatment in chronic Achilles tendinopathy: a double-blind randomized placebo-controlled trial. Am J Sports Med. 2011;39(8):1623-1629.

Patellar tendinopathy

Scott A, LaPrade RF, Harmon KG, et al. Platelet-Rich Plasma for Patellar Tendinopathy: A Randomized Controlled Trial of Leukocyte-Rich PRP or Leukocyte-Poor PRP Versus Saline. Am J Sports Med. 2019;47(7):1654-1661.

Andriolo L, Altamura SA, Reale D, Candrian C, Zaffagnini S, Filardo G. Nonsurgical Treatments of Patellar Tendinopathy: Multiple Injections of Platelet-Rich Plasma Are a Suitable Option: A Systematic Review and Meta-analysis. Am J Sports Med. 2019;47(4):1001-1018.

Surgical Augmentation of Repairs

Rodeo SA, Delos D, Williams RJ, Adler RS, Pearle A, Warren RF. The effect of platelet-rich fibrin matrix on rotator cuff tendon healing: a prospective, randomized clinical study. Am J Sports Med. 2012;40(6):12341241.

Wang A, McCann P, Colliver J, et al. Do postoperative platelet-rich plasma injections accelerate early tendon healing and functional recovery after arthroscopic supraspinatus repair? A randomized controlled trial. Am J Sports Med. 2015;43(6):1430-1437.

Flury M, Rickenbacher D, Schwyzer HK, et al. Does Pure Platelet-Rich Plasma Affect Postoperative Clinical Outcomes After Arthroscopic Rotator Cuff Repair? A Randomized Controlled Trial. Am J Sports Med. 2016;44(8):2136-2146.

De Carli A, Lanzetti RM, Ciompi A, et al. Can platelet-rich plasma have a role in Achilles tendon surgical repair? Knee surgery, sports traumatology, arthroscopy : official journal of the ESSKA. 2016;24(7):2231-2237.

Warth RJ, Dornan GJ, James EW, Horan MP, Millett PJ. Clinical and structural outcomes after arthroscopic repair of full-thickness rotator cuff tears with and without platelet-rich product supplementation: a meta-analysis and meta-regression. Arthroscopy. 2015;31(2):306-320.

Saltzman BM, Jain A, Campbell KA, et al. Does the Use of Platelet-Rich Plasma at the Time of Surgery Improve Clinical Outcomes in Arthroscopic Rotator Cuff Repair When Compared With Control Cohorts? A Systematic Review of Meta-analyses. Arthroscopy. 2016;32(5):906-918.

Osteoarthritis

Annaniemi JA, Pere J, Giordano S. Platelet-rich plasma versus hyaluronic acid injections for knee osteoarthritis: a propensity-score analysis. Scand J Surg. 2019;108(4):329-337.

Laudy AB, Bakker EW, Rekers M, Moen MH. Efficacy of platelet-rich plasma injections in osteoarthritis of the knee: a systematic review and meta-analysis. British journal of sports medicine. 2015;49(10):657-672.

Belk JW, Kraeutler MJ, Houck DA, Goodrich JA, Dragoo JL, McCarty EC. Platelet-Rich Plasma Versus Hyaluronic Acid for Knee Osteoarthritis: A Systematic Review and Meta-analysis of Randomized Controlled Trials. Am J Sports Med. 2020:363546520909397.

Lin K-Y, Yang C-C, Hsu C-J, Yeh M-L, Renn J-H. Intra-articular Injection of Platelet-Rich Plasma Is Superior to Hyaluronic Acid or Saline Solution in the Treatment of Mild to Moderate Knee Osteoarthritis: Randomized, Double-Blind, Triple-Parallel, Placebo-Controlled Clinical Trial. Arthroscopy. 2019;35(1):106-117.

Campbell KA, Saltzman BM, Mascarenhas R, et al. Does Intra-articular Platelet-Rich Plasma Injection Provide Clinically Superior Outcomes Compared With Other Therapies in the Treatment of Knee Osteoarthritis? A Systematic Review of Overlapping Meta-analyses. Arthroscopy. 2015;31(11):2213-2221.

Migliorini, F., Driessen, A., Quack, V. et al. Comparison between intra-articular infiltrations of placebo, steroids, hyaluronic and PRP for knee osteoarthritis: a Bayesian network meta-analysis. Arch Orthop Trauma Surg (2020). https://doi.org/10.1007/s00402-020-03551-yExternal Website

Elksninš-Finogejevs, A., Vidal, L. & Peredistijs, A. Intra-articular platelet-rich plasma vs corticosteroids in the treatment of moderate knee osteoarthritis: a single-center prospective randomized controlled study with a 1-year follow up. J Orthop Surg Res 15, 257 (2020). https://doi.org/10.1186/s13018-020-01753-zExternal Website

Reyes-Sosa R, Lugo-Radillo A, Cruz-Santiago L, García-Cruz CR, Mendoza-Cano O. Clinical comparison of platelet-rich plasma injection and daily celecoxib administration in the treatment of early knee osteoarthritis: A randomized clinical trial. J Appl Biomed. 2020;18(2-3):41-45. doi: 10.32725/jab.2020.012.

Xu, Z, He, Z, Shu L, Li, X, Ma, M, and Ye, C. Intra-Articular Platelet-Rich Plasma Combined With Hyaluronic Acid Injection for Knee Osteoarthritis Is Superior to Platelet-Rich Plasma or Hyaluronic Acid Alone in Inhibiting Inflammation and Improving Pain and Function Arthroscopy 2020. https://doi.org/10.1016/j.arthro.2020.10.013External Website

Yaradilimis, YU, Derirkale I, Safe Tagral A,et al., Comparison of two platelet rich plasma formulations with viscosupplementation in treatment of moderate grade gonarthrosis: A prospective randomized controlled study. J Orthop 2020; 20:240-246. https://doi.org/10.1016/j.jor.2020.01.041External Website

Low Back Pain

Navani A, Manchikanti L, Albers SL, et al. Responsible, Safe, and Effective Use of Biologics in the Management of Low Back Pain: American Society of Interventional Pain Physicians (ASIPP) Guidelines. Pain Physician. 2019;22(1s):S1-s74.

Akeda K, Yamada J, Linn ET, Sudo A, Masuda K. Platelet-rich plasma in the management of chronic low back pain: a critical review. J Pain Res. 2019;12:753-767.

Urits I, Viswanath O, Galasso AC, et al. Platelet-Rich Plasma for the Treatment of Low Back Pain: a Comprehensive Review. Current pain and headache reports. 2019;23(7):52.

Tuakli-Wosornu YA, Terry A, Boachie-Adjei K, et al. Lumbar Intradiskal Platelet-Rich Plasma (PRP) Injections: A Prospective, Double-Blind, Randomized Controlled Study. PM & R: the journal of injury, function, and rehabilitation. 2016;8(1):1-10; quiz 10.

Bise S, Dallaudiere B, Pesquer L, et al. Comparison of interlaminar CT-guided epidural platelet-rich plasma versus steroid injection in patients with lumbar radicular pain. European radiology. 2020

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