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ECRB Tendinopathy: Needling ± PRP After Failure of Rehabilitation

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ClinicalTrials.gov Identifier: NCT03987256
Recruitment Status : Not yet recruiting
First Posted : June 17, 2019
Last Update Posted : August 20, 2019
Sponsor:
Information provided by (Responsible Party):
Adrien Schwitzguebel, Hôpital de la Providence, Switzerland

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.


Condition or disease Intervention/treatment Phase
Tennis Elbow PRP Tendinopathy Tendinosis Extracorporal Shockwave Therapy (ESWT) Tendon Needling (Peppering) Extensor Carpi Radialis Brevis (ECRB) Other: Initial rehabilitation protocol Procedure: Needling with PRP Procedure: Needling with saline solution Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 58 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: In both groups, needling will be performed. Half of the patients will receive PRP (platelet-rich plasma).
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: 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.
Primary Purpose: Treatment
Official Title: Tennis Elbow, Randomized Study: Needling With and Without Platelet-rich Plasma After Failure of Up-to-date Rehabilitation
Estimated Study Start Date : January 2020
Estimated Primary Completion Date : January 2022
Estimated Study Completion Date : July 2022

Resource links provided by the National Library of Medicine


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.





Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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. 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)

  4. PRTEE score (Patient-Rated Tennis Elbow Evaluation) [ Time Frame: -3, 0, 3, 6, & 12 months ]
    Score going from 0 to 100 (0 = good outcome)

  5. Strength on Jamar test (hand grip strength) [ Time Frame: -3, 0, 3, 6, & 12 months ]
    Grip strength measured in Kg (Higher strength = better outcome)

  6. 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

  7. Volume of PRP prepared [ Time Frame: 0 months ]
    Descriptive statistics: Quantity of PRP prepared (in ml)

  8. Volume of PRP (or saline solution) injected [ Time Frame: 0 months ]
    Descriptive statistics: Quantity of PRP (or saline solution) injected (in ml)

  9. 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

  10. 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)

  11. 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

  12. 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

  13. 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)

  14. 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)



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03987256


Contacts
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Contact: Adrien Schwitzguébel, MD +4179 762 05 62 adrien.schwitzguebel@gmail.com

Locations
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Switzerland
Hôpital La Providence, Sports Medicine Not yet recruiting
Neuchâtel, Switzerland, 2000
Contact: Adrien Schwitzguébel, MD    +4179 762 05 62    adrien.schwitzguebel@gmail.com   
Sponsors and Collaborators
Adrien Schwitzguebel
Investigators
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Principal Investigator: Adrien Schwitzguébel, MD Hôpital de La Providence

Publications:

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Responsible Party: Adrien Schwitzguebel, Independent physician, Hôpital de la Providence, Switzerland
ClinicalTrials.gov Identifier: NCT03987256     History of Changes
Other Study ID Numbers: ECRB_Conservative
First Posted: June 17, 2019    Key Record Dates
Last Update Posted: August 20, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Adrien Schwitzguebel, Hôpital de la Providence, Switzerland:
tennis elbow
PRP
Focussed shockwave therapy
needling
tendinopathy

Additional relevant MeSH terms:
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Tendinopathy
Tennis Elbow
Muscular Diseases
Musculoskeletal Diseases
Tendon Injuries
Wounds and Injuries
Elbow Tendinopathy
Arm Injuries
Pharmaceutical Solutions