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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-000478-32 | EudraCT Number |
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Background Tendinopathy is a difficult problem to manage and can result in significant patient morbidity. Currently, the clinical use of PRP in painful tendons is widespread but its efficacy remains controversial. Current experimental research postulates different efficiency among PRP formulations.Recent reviews showed that most clinical studies in tendinopathies have been performed with L-PRP. The investigators aim to examine the efficacy of pure-PRP in the management of epicondylitis.
The investigators hypothesized that pure PRP associated to needling intervention can enhance tendon healing in epicondylitis, improve function and reduce pain.
Methods and design Randomized double blind controlled trial, a total of 80 patients will be randomly allocated into one of two groups: PRP or control. Interventions: PRP group, ultrasound (US)guided needling associated to delivery of multiple PRP depots each alternate week for a total of two interventions. Control Group: US-guided needling with lidocaine each alternate week for a total of two interventions. Main outcome measure: Changes in pain and activity levels, as assessed by Disabilities of the Arm, Shoulder and Hand (DASH)outcome measure score, before and six months after intervention.The primary end-point is 25% reduction in DASH. The investigators will compare the percentage of patients, in each group, that achieve a successful treatment defined as a reduction of at least 25% in the DASH score.
Secondary outcome measures:Changes in pain and function as assessed by DASH and changes in pain as assessed by the visual analogue scale (VAS)at the 3, 6 and 12 month follow-up. Changes in sonographic features and neovascularity at 3, 6 and 12 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| US-guided tenotomy with PRP | Experimental | ultrasound guided percutaneous tenotomy with PRP injection each alternate week for a total of two interventions |
|
| US-guided tenotomy with lidocaine | Active Comparator | ultrasound-guided percutaneous needle tenotomy with lidocaine injection each alternate week for a total of two interventions |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| US-guided tenotomy with PRP | Drug | Blood will be drawn from the patient from the patient's unaffected arm. the anti-coagulated blood will be centrifuged and pure-PRP (without leukocytes) collected. Local anesthetic (lidocaine) will be infiltrated into the subcutaneous tissue of the lateral elbow, after which a single skin portal and multiple longitudinal and transversal penetrations of the tendon will be performed; PRP will be delivered in multiple depots during the procedure |
| Measure | Description | Time Frame |
|---|---|---|
| changes in the DASH-E score | percentage of patients that achieve a successful treatment defined as a reduction of at least 25% in the DASH score compared with baseline | six months |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of patients that achieve a successful treatment | successful treatment defined as a reduction of greater than 25% of the DASH-E score | three and twelve months |
| Pain reduction as measured by VAS. |
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Inclusion criteria
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jose I Martin, MD | Cruces University Hospital, Osakidetza, Basque Health Service | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cruces University Hospital/BioCruces Health Research Institute | Barakaldo | Bizkaia | 48903 | Spain | ||
| Cruces University Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20718690 | Background | Andia I, Sanchez M, Maffulli N. Tendon healing and platelet-rich plasma therapies. Expert Opin Biol Ther. 2010 Oct;10(10):1415-26. doi: 10.1517/14712598.2010.514603. | |
| 34590307 | Derived | Karjalainen TV, Silagy M, O'Bryan E, Johnston RV, Cyril S, Buchbinder R. Autologous blood and platelet-rich plasma injection therapy for lateral elbow pain. Cochrane Database Syst Rev. 2021 Sep 30;9(9):CD010951. doi: 10.1002/14651858.CD010951.pub2. |
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| ID | Term |
|---|---|
| D052256 | Tendinopathy |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D013708 | Tendon Injuries |
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| D008012 | Lidocaine |
| D000779 | Anesthetics, Local |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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|
|
| US-guided tenotomy with lidocaine | Drug | Blood will be drawn from the patient from the patient's unaffected arm. Local anesthetic (lidocaine) will be infiltrated into the subcutaneous tissue of the lateral elbow, after which a single skin portal and multiple longitudinal and transversal penetrations of the tendon will be performed; lidocaine will be delivered in multiple depots during the procedure |
|
|
changes in pain rating on a visual analogue scale (VAS)with respect to baseline
| three, six and twelve months |
| changes in echogenicity and vascularity as assessed by Doppler sonography | three, six and twelve months |
| frequency, severity, intensity and duration of adverse events | three, six and twelve months |
| Barakaldo |
| Bizkaia |
| 48903 |
| Spain |
| 31014382 | Derived | 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. |
| 30609276 | Derived | Martin JI, Atilano L, Merino J, Gonzalez I, Iglesias G, Areizaga L, Bully P, Grandes G, Andia I. Predictors of Outcome Following Tenotomy in Patients with Recalcitrant Epicondylopathy. PM R. 2019 Sep;11(9):979-988. doi: 10.1002/pmrj.12064. Epub 2019 Mar 19. |
| 24289799 | Derived | Martin JI, Merino J, Atilano L, Areizaga LM, Gomez-Fernandez MC, Burgos-Alonso N, Andia I. Platelet-rich plasma (PRP) in chronic epicondylitis: study protocol for a randomized controlled trial. Trials. 2013 Dec 1;14:410. doi: 10.1186/1745-6215-14-410. |
| Aniline Compounds |
| D000588 | Amines |
| D000777 | Anesthetics |
| D002492 | Central Nervous System Depressants |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D018689 | Sensory System Agents |
| D018373 | Peripheral Nervous System Agents |
| D002491 | Central Nervous System Agents |
| D045506 | Therapeutic Uses |