Tennis ElbowNCT03987256
ECRB Tendinopathy: Needling ± PRP After Failure of Rehabilitation
A study testing Initial rehabilitation protocol, Needling with PRP and Needling with saline solution in people with Tennis Elbow and PRP, run by Adrien Schwitzguebel at 1 site in Switzerland.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Tennis Elbow, PRP, Tendinopathy
- What is being tested?
- Initial rehabilitation protocol, Needling with PRP and Needling with saline solution
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Jan 2020to Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 16Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Switzerland1 site, 1 recruiting
- Recruiting
Hôpital La Providence, Sports Medicine
Neuchâtel, 2000
Adrien Schwitzguébel, MD, +4179 762 05 62, adrien.schwitzguebel@gmail.com
About this study
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.
Read the 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.
- Conditions
- Tennis Elbow, PRP, Tendinopathy, Tendinosis, Extracorporal Shockwave Therapy (ESWT), Tendon Needling (Peppering)
- Being tested
- Initial rehabilitation protocol, Needling with PRP, Needling with saline solution
- Keywords
- tennis elbow, PRP, Focussed shockwave therapy, needling, tendinopathy
- Medical subject headings
- Tennis Elbow, Tendinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Initial rehabilitation protocolOther
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.
Needling with PRPProcedure or surgery
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.
Needling with saline solutionProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Other: Initial rehabilitation protocol; Procedure: Needling with saline solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 months
Secondary outcomes (14)
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
Measured: -3, 0, 6, & 12 months
Overall pain evaluation (mean of the 3 last days)
Pain is evaluated on a 0-10 scale (0 = no pain)
Measured: -3, 0, 3, 6, & 12 months
SANE score (Single Assessment Numeric Evaluation)
Function is evaluated on a 0-100% scale (100 = good function)
Measured: -3, 0, 3, 6, & 12 months
PRTEE score (Patient-Rated Tennis Elbow Evaluation)
Score going from 0 to 100 (0 = good outcome)
Measured: -3, 0, 3, 6, & 12 months
Strength on Jamar test (hand grip strength)
Grip strength measured in Kg (Higher strength = better outcome)
Measured: -3, 0, 3, 6, & 12 months
Proportion of patient cured with reeducation protocol
Descriptive statistics: Evaluation of the proportion of patients for which the tendon needling is not necessary
Measured: 0 months
Volume of PRP prepared
Descriptive statistics: Quantity of PRP prepared (in ml)
Measured: 0 months
Volume of PRP (or saline solution) injected
Descriptive statistics: Quantity of PRP (or saline solution) injected (in ml)
Measured: 0 months
Ultrasonographic aspect of the epicondylar tendon: Hypoechogenic lesion
The tridimensional volume of the lesion is measured in mm^3
Measured: -3, 0, 3, & 6 months
Ultrasonographic aspect of the epicondylar tendon: Doppler
The Doppler reaction will be evaluated on a subjective scale (none, mild, average, high, huge)
Measured: -3, 0, 3, & 6 months
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
Measured: -3, 0, 3, & 6 months
Ultrasonographic aspect of the epicondylar tendon: Thickness
The thickness of the common epitrochlear will be measured in mm
Measured: -3, 0, 3, & 6 months
Ultrasonographic aspect of the epicondylar tendon: Compressibility
The presence or absence of compressibility of the common epitrochlear tendon (binary outcome)
Measured: -3, 0, 3, & 6 months
Ultrasonography of the epicondylar tendon: Sonopalpation
The patient pain on sonopalpation will be evaluated on a 0-10 scale (0= no pain)
Measured: -3, 0, 3, & 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2019
- Study start1 Jan 2020
- Primary completionJan 2022 (estimated)
- Study completionJul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Tennis ElbowStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- In both groups, needling will be performed. Half of the patients will receive PRP (platelet-rich plasma).
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 58 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Adrien Schwitzguebel
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Adrien Schwitzguebel, Hôpital de la Providence, Switzerland
- Investigators
- Adrien Schwitzguébel, MD, Principal investigator, Hôpital de La Providence
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03987256
- Sponsor's protocol ID
- ECRB_Conservative
- Status last verified
- Sep 2021
- First submitted
- 13 Jun 2019
- Last updated
- 20 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 26327530Park 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.
PubMed 27152280Coombes 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.
PubMed 20970844Houck 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.
PubMed 30899764Gautam 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.
PubMed 25920633Dong 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.
PubMed 26392595Sims 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.
PubMed 25414603Lai 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.
PubMed 30464656Imam 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.
PubMed 28990575Mi 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.
PubMed 28276986Martin 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.
PubMed 31014382Schoffl 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.
PubMed 28222465Montalvan 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.
PubMed 26350485Mishra 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.
PubMed 23825183Behera 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.
PubMed 25920634
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tennis Elbow, Randomized Study: Needling With and Without Platelet-rich Plasma After Failure of Up-to-date Rehabilitation
- ClinicalTrials.gov ID
- NCT03987256
- Acronym / sponsor ID
- ECRB_Conservative
- Conditions
- Tennis Elbow, PRP, Tendinopathy, Tendinosis, Extracorporal Shockwave Therapy (ESWT), Tendon Needling (Peppering)
- Keywords
- tennis elbow, PRP, Focussed shockwave therapy, needling, tendinopathy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 58 participants (estimated)
- Lead sponsor
- Adrien SchwitzguebelUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- Jan 2022 (estimated)
- Study completion
- Jul 2022 (estimated)
- First posted
- 17 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- In both groups, needling will be performed. Half of the patients will receive PRP (platelet-rich plasma).
| Arm | Type | Receives |
|---|---|---|
| ECRB needling with adjuvant PRP infiltration | Experimental | Other: Initial rehabilitation protocol, Procedure: Needling with PRPFirst step: rehabilitation protocol during 3 months including focal shockwave therapy Second step: one single tendon needling with PRP |
| ECRB needling with adjuvant NaCl 0.9% infiltration | Active comparator | Other: Initial rehabilitation protocol, Procedure: Needling with saline solutionFirst step: rehabilitation protocol during 3 months including focal shockwave therapy Second step: one single tendon needling with Saline solution |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Initial rehabilitation protocolDuring 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. | Other | ECRB needling with adjuvant NaCl 0.9% infiltration, ECRB needling with adjuvant PRP infiltration |
| Needling with PRPIn 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 or surgery | ECRB needling with adjuvant PRP infiltration |
| Needling with saline solutionIn 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. | Procedure or surgery | ECRB needling with adjuvant NaCl 0.9% infiltration |
Primary outcome
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
14 secondary outcomes
Pain during isometric contraction of the ECRB
Time frame: -3, 0, 6, & 12 months
Overall pain evaluation (mean of the 3 last days)
Time frame: -3, 0, 3, 6, & 12 months
SANE score (Single Assessment Numeric Evaluation)
Time frame: -3, 0, 3, 6, & 12 months
PRTEE score (Patient-Rated Tennis Elbow Evaluation)
Time frame: -3, 0, 3, 6, & 12 months
Strength on Jamar test (hand grip strength)
Time frame: -3, 0, 3, 6, & 12 months
Proportion of patient cured with reeducation protocol
Time frame: 0 months
Volume of PRP prepared
Time frame: 0 months
Volume of PRP (or saline solution) injected
Time frame: 0 months
Ultrasonographic aspect of the epicondylar tendon: Hypoechogenic lesion
Time frame: -3, 0, 3, & 6 months
Ultrasonographic aspect of the epicondylar tendon: Doppler
Time frame: -3, 0, 3, & 6 months
Ultrasonographic aspect of the epicondylar tendon: Solution of continuity
Time frame: -3, 0, 3, & 6 months
Ultrasonographic aspect of the epicondylar tendon: Thickness
Time frame: -3, 0, 3, & 6 months
Ultrasonographic aspect of the epicondylar tendon: Compressibility
Time frame: -3, 0, 3, & 6 months
Ultrasonography of the epicondylar tendon: Sonopalpation
Time frame: -3, 0, 3, & 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2021.
- Background: PubMed 26327530Gerdesmeyer 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.
- Background: PubMed 27152280Park 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.
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- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adrien Schwitzguébel, MD principal investigator
Hôpital de La Providence
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Initial rehabilitation protocol, Needling with PRP and Needling with saline solution in people with Tennis Elbow and PRP, run by Adrien Schwitzguebel at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Adrien Schwitzguébel, MD (+4179 762 05 62, adrien.schwitzguebel@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain during isometric contraction of the ECRB (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03987256, which also lists 17 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Sep 2021.