ECRB Tendinopathy: Needling ± PRP After Failure of Rehabilitation

NCT03987256 | Unknown

• 1 other identifier: ECRB_Conservative
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Tennis Elbow; PRP; Tendinopathy; Tendinosis; Extracorporal Shockwave Therapy (ESWT); Tendon Needling (Peppering); Extensor Carpi Radialis Brevis (ECRB)

Keywords

tennis elbow; PRP; Focussed shockwave therapy; needling; tendinopathy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (14)

• Pain during isometric contraction of the ECRB

  -3, 0, 6, & 12 months

• Overall pain evaluation (mean of the 3 last days)

  -3, 0, 3, 6, & 12 months

• SANE score (Single Assessment Numeric Evaluation)

  -3, 0, 3, 6, & 12 months

• PRTEE score (Patient-Rated Tennis Elbow Evaluation)

  -3, 0, 3, 6, & 12 months

• Strength on Jamar test (hand grip strength)

  -3, 0, 3, 6, & 12 months

Study Arms (2)

ECRB needling with adjuvant PRP infiltration

EXPERIMENTAL

First step: rehabilitation protocol during 3 months including focal shockwave therapy Second step: one single tendon needling with PRP

Other: Initial rehabilitation protocol; Procedure: Needling with PRP

ECRB needling with adjuvant NaCl 0.9% infiltration

ACTIVE COMPARATOR

First step: rehabilitation protocol during 3 months including focal shockwave therapy Second step: one single tendon needling with Saline solution

Other: Initial rehabilitation protocol; Procedure: Needling with saline solution

Interventions

Initial rehabilitation protocol OTHER

During 12 weeks, under kinesitherapist guidance, patients will perform daily eccentric stretching and strengthening of the ECRB and periscapular musculature, manual therapies, and kinesiotaping. They will also use orthotics after 6 weeks if kinesiotaping is not effective. At weeks 1-5, patients will undergo weekly ultrasound-guided focused shockwave therapy under the following protocol: 0,15- 0,30mJ/mm2 (the highest energy flux the patient can well tolerate), 1500 shocks at 5Hz at the origin of common extensor or flexor tendon.

ECRB needling with adjuvant NaCl 0.9% infiltration; ECRB needling with adjuvant PRP infiltration

Needling with PRP PROCEDURE

In case of failure of proper rehabilitation and shockwave therapy, patients will have a block of the radialis nerve just above the arcade of Frohse with 1 ml of procaine 2%. Then, a single needling of the ECRB enthesis (peppering technique) will be performed as follow: , ultrasound-guided, 25 repetitions with a 20 gauge needle. At the end of the procedure, the lesion will be fulfilled with PRP. Details of PRP preparation (ACP Arthrex): 15 ml of blood, no activators or anticoagulants, poor in white blood cells (the last mm of buffy coat above the red blood cells pellet is not collected). Excentric stretching and strengthening, as well as orthotics or kinesiotaping will be continued as long as symptoms persists during the 6 first months after the needling procedure.

ECRB needling with adjuvant PRP infiltration

Needling with saline solution PROCEDURE

In case of failure of proper rehabilitation and shockwave therapy, patients will have a block of the radialis nerve just above the arcade of Frohse with 1 ml of procaine 2%. Then, a single needling of the ECRB enthesis (peppering technique) will be performed as follow: , ultrasound-guided, 25 repetitions with a 20 gauge needle. At the end of the procedure, the lesion will be fulfilled with saline solution. Excentric stretching and strengthening, as well as orthotics or kinesiotaping will be continued as long as symptoms persists during the 6 first months after the needling procedure.

ECRB needling with adjuvant NaCl 0.9% infiltration

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Presence on ultrasound of an isolated lesion of the superficial epicondylar tendons as described above, with intact ECRB
• 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

Sponsors & Collaborators

• Adrien Schwitzguebel: lead

Study Sites (1)

Hôpital La Providence, Sports Medicine

Neuchâtel, 2000, Switzerland

RECRUITING

Related Publications (17)

• 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.

  PMID: 26327530 BACKGROUND

• Park JW, Hwang JH, Choi YS, Kim SJ. Comparison of Therapeutic Effect of Extracorporeal Shock Wave in Calcific Versus Noncalcific Lateral Epicondylopathy. Ann Rehabil Med. 2016 Apr;40(2):294-300. doi: 10.5535/arm.2016.40.2.294. Epub 2016 Apr 25.

  PMID: 27152280 BACKGROUND

• 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.

  PMID: 20970844 BACKGROUND

• 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.

  PMID: 30899764 BACKGROUND

• 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. doi: 10.1177/230949901502300101.

  PMID: 25920633 BACKGROUND

• 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.

  PMID: 26392595 BACKGROUND

• Sims SE, Miller K, Elfar JC, Hammert WC. Non-surgical treatment of lateral epicondylitis: a systematic review of randomized controlled trials. Hand (N Y). 2014 Dec;9(4):419-46. doi: 10.1007/s11552-014-9642-x.

  PMID: 25414603 BACKGROUND

• 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.

  PMID: 30464656 BACKGROUND

• 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.

  PMID: 28990575 BACKGROUND

• 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.

  PMID: 28276986 BACKGROUND

• 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.

  PMID: 31014382 BACKGROUND

• Schoffl V, Willauschus W, Sauer F, Kupper T, Schoffl I, Lutter C, Gelse K, Dickschas J. Autologous Conditioned Plasma Versus Placebo Injection Therapy in Lateral Epicondylitis of the Elbow: A Double Blind, Randomized Study. Sportverletz Sportschaden. 2017 Jan;31(1):31-36. doi: 10.1055/s-0043-101042. Epub 2017 Feb 21.

  PMID: 28222465 BACKGROUND

• 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.

  PMID: 26350485 BACKGROUND

• 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.

  PMID: 23825183 BACKGROUND

• 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. doi: 10.1177/230949901502300102.

  PMID: 25920634 BACKGROUND

• 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.

  PMID: 28759287 BACKGROUND

• Schwitzguebel AJ, Bogoev M, Nikolov V, Ichane F, Ladermann A. Tennis elbow, study protocol for a randomized clinical trial: needling with and without platelet-rich plasma after failure of up-to-date rehabilitation. J Orthop Surg Res. 2020 Oct 7;15(1):462. doi: 10.1186/s13018-020-01998-8.

  PMID: 33028383 DERIVED

MeSH Terms

Conditions

Tennis Elbow; Tendinopathy

Interventions

Saline Solution

Condition Hierarchy (Ancestors)

Elbow Tendinopathy; Muscular Diseases; Musculoskeletal Diseases; Elbow Injuries; Arm Injuries; Wounds and Injuries; Tendon Injuries

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Adrien Schwitzguébel, MD

  Hôpital de La Providence

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Adrien Schwitzguébel, MD

CONTACT

+4179 762 05 62; adrien.schwitzguebel@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: All patients will have blood puncture. Then, the research coordinator will prepare either an opaque syringe of saline solution or of PRP. At the end of the needling procedure, the investigator will inject the content of the opaque syringe.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Independent physician

Model Details: In both groups, needling will be performed. Half of the patients will receive PRP (platelet-rich plasma).

Study Record Dates

• First Submitted: June 13, 2019
• First Posted: June 17, 2019
• Study Start: January 1, 2020
• Primary Completion: January 1, 2022
• Study Completion: July 1, 2022
• Last Updated: September 20, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)