Tendinopathy Clinical Trial
Official title:
Tennis Elbow, Randomized Study: Needling With and Without Platelet-rich Plasma After Failure of Up-to-date Rehabilitation
This study evaluates the effect of platelet-rich plasma (PRP) use during needling of the extensor carpalis radialis brevis tendon, after failure of proper reeducation including focal extra-corporal shockwave therapy (ESWT). Half of the patients with receive PRP and needling, and half of the patients will receive needling alone. During the reeducation, the clinical evaluation will be monitored and reported as in a case series.
Status | Recruiting |
Enrollment | 58 |
Est. completion date | July 2022 |
Est. primary completion date | January 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | Inclusion Criteria: - Lesion of the ECRB tendon on ultrasonography ([hypoechogenic area during rest OR hypoechogenic area during active contraction, OR compressibility of the tendon OR doppler signal] AND [positive sonopalpation]) - Failure to rehabilitation program including shockwave therapy defined as the need for the patient undergoing additional therapies Exclusion Criteria: - Presence on ultrasound of an isolated lesion of the superficial epicondylar tendons as described above, with intact ECRB - Presence on ultrasound of any of: radiohumeral synovial material; interruption of the lateral collateral ligament; radial nerve entrapment, i.e. under the arcade of Frohse; osteochondral lesion; joint effusion. Note: calcic enthesophytes are not considered as an exclusion criteria - Clinical presence of cervicobrachialgia, or pain irradiating into the hand - Corticosteroids: oral intake or infiltration on the last 3 months - Proximal radius fracture history - Active inflammatory rheumatic disorders - Diabetes mellitus - Immunocompromized status - Allergy to local anesthetics - Bleeding disorders or current anticoagulation therapy - Other clinically significant concomitant disease states (e.g., renal failure, hepatic dysfunction, cardiopulmonary significant insufficiency, etc.) - Known or suspected non-compliance, drug or alcohol abuse - Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant - Participation in another study with investigational drug within the 30 days preceding and during the present study - Previous enrolment into the current study - Enrolment of the investigator, his/her family members, employees and other dependent persons |
Country | Name | City | State |
---|---|---|---|
Switzerland | Hôpital La Providence, Sports Medicine | Neuchâtel |
Lead Sponsor | Collaborator |
---|---|
Adrien Schwitzguebel |
Switzerland,
Behera P, Dhillon M, Aggarwal S, Marwaha N, Prakash M. Leukocyte-poor platelet-rich plasma versus bupivacaine for recalcitrant lateral epicondylar tendinopathy. J Orthop Surg (Hong Kong). 2015 Apr;23(1):6-10. — View Citation
Coombes BK, Bisset L, Vicenzino B. Efficacy and safety of corticosteroid injections and other injections for management of tendinopathy: a systematic review of randomised controlled trials. Lancet. 2010 Nov 20;376(9754):1751-67. doi: 10.1016/S0140-6736(10)61160-9. Epub 2010 Oct 21. Review. — View Citation
Dong W, Goost H, Lin XB, Burger C, Paul C, Wang ZL, Kong FL, Welle K, Jiang ZC, Kabir K. Injection therapies for lateral epicondylalgia: a systematic review and Bayesian network meta-analysis. Br J Sports Med. 2016 Aug;50(15):900-8. doi: 10.1136/bjsports-2014-094387. Epub 2015 Sep 21. Review. — View Citation
Gautam VK, Verma S, Batra S, Bhatnagar N, Arora S. Platelet-rich plasma versus corticosteroid injection for recalcitrant lateral epicondylitis: clinical and ultrasonographic evaluation. J Orthop Surg (Hong Kong). 2015 Apr;23(1):1-5. — View Citation
Gerdesmeyer L, Mittermayr R, Fuerst M, Al Muderis M, Thiele R, Saxena A, Gollwitzer H. Current evidence of extracorporeal shock wave therapy in chronic Achilles tendinopathy. Int J Surg. 2015 Dec;24(Pt B):154-9. doi: 10.1016/j.ijsu.2015.07.718. Epub 2015 Aug 29. Review. — View Citation
Houck DA, Kraeutler MJ, Thornton LB, McCarty EC, Bravman JT. Treatment of Lateral Epicondylitis With Autologous Blood, Platelet-Rich Plasma, or Corticosteroid Injections: A Systematic Review of Overlapping Meta-analyses. Orthop J Sports Med. 2019 Mar 14;7(3):2325967119831052. doi: 10.1177/2325967119831052. eCollection 2019 Mar. Review. — View Citation
Imam MA, Holton J, Horriat S, Negida AS, Grubhofer F, Gupta R, Narvani A, Snow M. A systematic review of the concept and clinical applications of bone marrow aspirate concentrate in tendon pathology. SICOT J. 2017;3:58. doi: 10.1051/sicotj/2017039. Epub 2017 Oct 9. — View Citation
Kaux JF, Emonds-Alt T. The use of platelet-rich plasma to treat chronic tendinopathies: A technical analysis. Platelets. 2018 May;29(3):213-227. doi: 10.1080/09537104.2017.1336211. Epub 2017 Jul 31. Review. — View Citation
Lai WC, Erickson BJ, Mlynarek RA, Wang D. Chronic lateral epicondylitis: challenges and solutions. Open Access J Sports Med. 2018 Oct 30;9:243-251. doi: 10.2147/OAJSM.S160974. eCollection 2018. Review. — View Citation
Martin JI, Atilano L, Merino J, Gonzalez I, Iglesias G, Areizaga L, Bully P, Grandes G, Andia I. Platelet-rich plasma versus lidocaine as tenotomy adjuvants in people with elbow epicondylopathy: a randomized controlled trial. J Orthop Surg Res. 2019 Apr 23;14(1):109. doi: 10.1186/s13018-019-1153-6. — View Citation
Mi B, Liu G, Zhou W, Lv H, Liu Y, Wu Q, Liu J. Platelet rich plasma versus steroid on lateral epicondylitis: meta-analysis of randomized clinical trials. Phys Sportsmed. 2017 May;45(2):97-104. doi: 10.1080/00913847.2017.1297670. Epub 2017 Mar 3. — View Citation
Mishra AK, Skrepnik NV, Edwards SG, Jones GL, Sampson S, Vermillion DA, Ramsey ML, Karli DC, Rettig AC. 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 Feb;42(2):463-71. doi: 10.1177/0363546513494359. Epub 2013 Jul 3. — View Citation
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). 2016 Feb;55(2):279-85. doi: 10.1093/rheumatology/kev326. Epub 2015 Sep 8. — View Citation
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* Note: There are 16 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Pain during isometric contraction of the ECRB | Pain is evaluated on a 0-10 scale (0 = no pain) during isometric contraction maneuver of the ECRB | 3 months | |
Secondary | Pain during isometric contraction of the ECRB | Pain is evaluated on a 0-10 scale (0 = no pain) during isometric contraction maneuver of the ECRB | -3, 0, 6, & 12 months | |
Secondary | Overall pain evaluation (mean of the 3 last days) | Pain is evaluated on a 0-10 scale (0 = no pain) | -3, 0, 3, 6, & 12 months | |
Secondary | SANE score (Single Assessment Numeric Evaluation) | Function is evaluated on a 0-100% scale (100 = good function) | -3, 0, 3, 6, & 12 months | |
Secondary | PRTEE score (Patient-Rated Tennis Elbow Evaluation) | Score going from 0 to 100 (0 = good outcome) | -3, 0, 3, 6, & 12 months | |
Secondary | Strength on Jamar test (hand grip strength) | Grip strength measured in Kg (Higher strength = better outcome) | -3, 0, 3, 6, & 12 months | |
Secondary | Proportion of patient cured with reeducation protocol | Descriptive statistics: Evaluation of the proportion of patients for which the tendon needling is not necessary | 0 months | |
Secondary | Volume of PRP prepared | Descriptive statistics: Quantity of PRP prepared (in ml) | 0 months | |
Secondary | Volume of PRP (or saline solution) injected | Descriptive statistics: Quantity of PRP (or saline solution) injected (in ml) | 0 months | |
Secondary | Ultrasonographic aspect of the epicondylar tendon: Hypoechogenic lesion | The tridimensional volume of the lesion is measured in mm^3 | -3, 0, 3, & 6 months | |
Secondary | Ultrasonographic aspect of the epicondylar tendon: Doppler | The Doppler reaction will be evaluated on a subjective scale (none, mild, average, high, huge) | -3, 0, 3, & 6 months | |
Secondary | Ultrasonographic aspect of the epicondylar tendon: Solution of continuity | During active contraction of the ECRB, an eventual solution of continuity will be measured in mm | -3, 0, 3, & 6 months | |
Secondary | Ultrasonographic aspect of the epicondylar tendon: Thickness | The thickness of the common epitrochlear will be measured in mm | -3, 0, 3, & 6 months | |
Secondary | Ultrasonographic aspect of the epicondylar tendon: Compressibility | The presence or absence of compressibility of the common epitrochlear tendon (binary outcome) | -3, 0, 3, & 6 months | |
Secondary | Ultrasonography of the epicondylar tendon: Sonopalpation | The patient pain on sonopalpation will be evaluated on a 0-10 scale (0= no pain) | -3, 0, 3, & 6 months |
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