ECRB Tendinopathy: Needling ± PRP After Failure of Rehabilitation

NCT03987256 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 58

Last updated 2021-09-20

No results posted yet for this study

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)

Interventions

OTHER

Initial rehabilitation protocol

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.

PROCEDURE

Needling with PRP

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.

PROCEDURE

Needling with saline solution

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.

Sponsors & Collaborators

  • Adrien Schwitzguebel

    lead OTHER

Principal Investigators

  • Adrien Schwitzguébel, MD · Hôpital de La Providence

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-01-01
Primary Completion
2022-01-31
Completion
2022-07-31

Countries

  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03987256 on ClinicalTrials.gov