ECRB Tendinopathy: Needling ± PRP After Failure of Rehabilitation

September 17, 2021 updated by: Adrien Schwitzguebel

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The conservative management of lateral epicondylitis is known to be a difficult-to-treat annoying condition. The first-line conservative management includes physical therapies with adjuvant painkillers and orthotics, and usually extracorporal shockwave therapy (ESWT). In clinical practice, infiltrative therapies a performed either before or after shockwave therapies. In the author's point of view, they represent a second-line conservative treatment.

The success rate of ESWT for lateral epicondylitis depends mainly of the protocol used. Especially, poor results were observed with too low energy. Both radial and focal ESWT are effective, and focal ESWT has been showed as being as effective as surgical tenotomy.

Concerning infiltrative therapies, it has been well established that corticosteroids are efficient in short-term but deleterious in long-term, likely for degenerative purposes. Prolotherapy, autologous blood, and botulinic toxin injections and others infiltrative therapies are less studied and therefore nowadays not clearly supported by the literature. Stem cells might be an alternative in the future.

Platelet-rich-plasma (PRP) is nowadays widely used, but the results of clinical trials are discordant. Even if the superiority of PRP over corticosteroids is well established, the superiority of PRP on tendon needling or peppering is still controversial. Martin et al. 2019 found in a partially blinded randomized controlled trial (RCT) involving 71 patients no clinical differences at 6 months of follow-up between 2 sessions of peppering with saline + local anesthetic and PRP + local anesthetic. In a similar unblended RCT involving 50 patients, Schöffl et al. 2017 found no clinical differences at 6 months of follow-up. Montalvan et al. 2016 found in a RCT involving 50 patients between 2 infiltrations of PRP and saline no clinical differences at 6 months of follow-up. Rehabilitation was not allowed during the trial and the tendon was not peppered. Mishra et al. found in a blinded RCT involving 119 patients a positive clinical effect of PRP on saline solution, using a single injection with peppering. Behera et al. found similar results in a small RCT on 25 patients.

Some factors has been advocated to influence the outcomes. The most relevant are: direct mechanic action of the needle and fenestration (peppering) technique, number of PRP injections, cells count (platelets, white blood- and red blood cells), activation of the platelets, concomitant local anesthetic use, peri-interventional use of NSAIDs and corticosteroids, concomitant rehabilitation or a contraria immobilization. Whether the positive results observed into the previous selected studies are due to either PRP, peppering, or any of the confounding factors described above remains to debate.

The first aim of this study is to determine the proportion of patients, which would need an infiltrative technique after a proper rehabilitation protocol involving physical therapies, orthotics and ESWT. Our second aim is to establish whether PRP as adjuvant therapy to peppering would increase clinical outcomes.

Details of sample size calculation (58 overall, 29 per group):

58 patients are required to have a 95% chance of detecting, as significant at the 5% level, an increase in the primary outcome measure from 50 in the control group to 60 in the experimental group, considering a standard deviation of 10% and a dropout rate of 10%. After the inclusion of 40 patients, the standard deviation will be re-evaluated and the sample size corrected accordingly if necessary.

Study Type

Interventional

Enrollment (Anticipated)

58

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 63 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ECRB needling with adjuvant PRP infiltration

First step: rehabilitation protocol during 3 months including focal shockwave therapy

Second step: one single tendon needling with PRP
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.
Active Comparator: ECRB needling with adjuvant NaCl 0.9% infiltration

First step: rehabilitation protocol during 3 months including focal shockwave therapy

Second step: one single tendon needling with Saline solution
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 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain during isometric contraction of the ECRB
Time Frame: 3 months
Pain is evaluated on a 0-10 scale (0 = no pain) during isometric contraction maneuver of the ECRB
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain during isometric contraction of the ECRB
Time Frame: -3, 0, 6, & 12 months
Pain is evaluated on a 0-10 scale (0 = no pain) during isometric contraction maneuver of the ECRB
-3, 0, 6, & 12 months
Overall pain evaluation (mean of the 3 last days)
Time Frame: -3, 0, 3, 6, & 12 months
Pain is evaluated on a 0-10 scale (0 = no pain)
-3, 0, 3, 6, & 12 months
SANE score (Single Assessment Numeric Evaluation)
Time Frame: -3, 0, 3, 6, & 12 months
Function is evaluated on a 0-100% scale (100 = good function)
-3, 0, 3, 6, & 12 months
PRTEE score (Patient-Rated Tennis Elbow Evaluation)
Time Frame: -3, 0, 3, 6, & 12 months
Score going from 0 to 100 (0 = good outcome)
-3, 0, 3, 6, & 12 months
Strength on Jamar test (hand grip strength)
Time Frame: -3, 0, 3, 6, & 12 months
Grip strength measured in Kg (Higher strength = better outcome)
-3, 0, 3, 6, & 12 months
Proportion of patient cured with reeducation protocol
Time Frame: 0 months
Descriptive statistics: Evaluation of the proportion of patients for which the tendon needling is not necessary
0 months
Volume of PRP prepared
Time Frame: 0 months
Descriptive statistics: Quantity of PRP prepared (in ml)
0 months
Volume of PRP (or saline solution) injected
Time Frame: 0 months
Descriptive statistics: Quantity of PRP (or saline solution) injected (in ml)
0 months
Ultrasonographic aspect of the epicondylar tendon: Hypoechogenic lesion
Time Frame: -3, 0, 3, & 6 months
The tridimensional volume of the lesion is measured in mm^3
-3, 0, 3, & 6 months
Ultrasonographic aspect of the epicondylar tendon: Doppler
Time Frame: -3, 0, 3, & 6 months
The Doppler reaction will be evaluated on a subjective scale (none, mild, average, high, huge)
-3, 0, 3, & 6 months
Ultrasonographic aspect of the epicondylar tendon: Solution of continuity
Time Frame: -3, 0, 3, & 6 months
During active contraction of the ECRB, an eventual solution of continuity will be measured in mm
-3, 0, 3, & 6 months
Ultrasonographic aspect of the epicondylar tendon: Thickness
Time Frame: -3, 0, 3, & 6 months
The thickness of the common epitrochlear will be measured in mm
-3, 0, 3, & 6 months
Ultrasonographic aspect of the epicondylar tendon: Compressibility
Time Frame: -3, 0, 3, & 6 months
The presence or absence of compressibility of the common epitrochlear tendon (binary outcome)
-3, 0, 3, & 6 months
Ultrasonography of the epicondylar tendon: Sonopalpation
Time Frame: -3, 0, 3, & 6 months
The patient pain on sonopalpation will be evaluated on a 0-10 scale (0= no pain)
-3, 0, 3, & 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Adrien Schwitzguebel

Investigators

  • Principal Investigator: Adrien Schwitzguébel, MD, Hôpital de La Providence

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2020

Primary Completion (Anticipated)

January 1, 2022

Study Completion (Anticipated)

July 1, 2022

Study Registration Dates

First Submitted

June 13, 2019

First Submitted That Met QC Criteria

June 13, 2019

First Posted (Actual)

June 17, 2019

Study Record Updates

Last Update Posted (Actual)

September 20, 2021

Last Update Submitted That Met QC Criteria

September 17, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ECRB_Conservative

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Tendinopathy

Clinical Trials on Initial rehabilitation protocol

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Kuwait

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe