Evaluation of Three Types of Injection for the Treatment of Lateral Epicondylalgia (LET)

Leukocyte and Platelet Rich Plasma Versus Type A Botulinum Toxin Versus Glucocorticoids for the Treatment of Lateral Epicondylalgia: a Randomized, Multicenter, Double-blind, Therapeutic Trial With Three Parallel Arms

The primary objective of this study is to compare the evolution of pain profiles among patients suffering from lateral epicondyalgia (tennis elbow) following three types of treatment: PRP-L injection versus type A botulinum toxin injection versus corticoid injection.

Study Overview

• Status: Terminated
• Conditions: Tennis Elbow; Epicondylitis, Lateral Humeral
• Intervention / Treatment: Drug: PRP-L Injection; Drug: Botox injection; Drug: Corticoid injection

Detailed Description

The secondary objectives are to compare the following among the three groups:

A- The global efficacy of each treatment defined by a minimum reduction of 25% in average pain over the last 24 hours between 0 and 6 months.

B- The evolution of average pain over the last 24 hours between 0 and each different time frame (3 weeks, 6 weeks, 3 months and 6 months).

C- The evolution of maximum pain scores using nocturnal post-effort (Jamar grip test) visual analog scales (VAS) between day 0, 3 weeks, 6 weeks, 3 months and 6 months.

D- The perception of change on the Patient's Global Impression of Change score (PGIC) at 3 and 6 months E- The evolution of PRTEE scores at 0, 3 and 6 months F- Adverse events at 3 weeks, 6 weeks, 3 months and 6 months. G - Quality of life and utility via the SF-12 at 3 and 6 months. H- The consumption of analgesics.

• Study Type: Interventional
• Enrollment (Actual): 13
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Montpellier, France, 34295
    • CHRU de Montpellier - Hôpital Lapeyronie
  • Nîmes, France, 30029
    • CHRU de Nîmes - Hôpital Universitaire Carémeau

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

General inclusion criteria:

• The patient must have given free and informed consent and signed the consent
• The patient must be affiliated or beneficiary to a health insurance plan
• The patient is available for 6 months of follow-up
• Woman of childbearing age using contraception

Inclusion criteria for the target population: the patient has a side epicondylalgia objectified by:

• Clinical criteria: symptoms lasting for more than 6 weeks and less than 12 months. The list of symptoms to be present are: pain on palpation of the lateral epicondyle, pain in the lateral epicondyle during blocked contraction
• Therapeutic: less than two injections of corticosteroids performed, and the last such injection was performed at least 3 months before inclusion

General non-inclusion criteria:

• The patient is participating in another study
• The patient is exclusion period determined by a previous study
• The patient is under judicial protection
• The patient is under guardianship or curatorship
• The patient refuses to sign the consent
• Woman of childbearing age not using contraception
• Impossible to correction inform the patient about the study

Non-inclusion criteria for investigational and auxiliary medicinal products:

• The patient has at least one of the contra-indications listed in the SPC for Xeomin and ALTIM:
• Hypersensitivity to Botulinum neurotoxin type A or Cortivazol
• Hypersensitivity to any of the excipients used in the composition of XEOMIN (Human albumin, sucrose) and / or ALTIM (Benzyl alcohol, carmellose sodium, sodium chloride, cetylpyridinium chloride, polysorbate 80)
• Generalized disorders of muscle activity (eg myasthenia gravis, Lambert-Eaton syndrome).
• Severe coagulation disorders, anticoagulation in progress (ticlopidine, clopidogrel, other antiplatelet or antithrombotic agents)
• Presence of a local or general infection, suspected infection, infection at the proposed injection site.

Non-inclusion criteria for the medical device used for the PRP samples (SmartPReP2 sampling system):

• Clinical or laboratory evidence for sepsis
• Taking aspirin or other drugs altering platelet function in the previous 3 days
• Patient with the platelet dysfunction disorders

Non-inclusion criteria for interfering diseases or conditions:

• The patient is pregnant, parturient or she is breastfeeding
• The patient has an allergy to botulinum toxin type A and / or glucocorticoids
• The patient has medial epicondylalgia
• The patient has a history of elbow surgery
• The patient has any of the following conditions: immunodeficiency, rheumatic disease, hepatitis, diabetes, another disease of the ipsilateral limb, neurological disorder (radiculopathy, compression of the radial nerve), any myopathy (all etiologies)
• The patient received treatment with corticosteroids in the last 3 months
• The patient is being treated with long-term anti-platelet medication

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PRP-L Group; Patients randomized to this group will be treated with an injection of Leukocyte and Platelet Rich Plasma (PRP-L). Intervention: PRP-L Injection	Drug: PRP-L Injection; Patients will be treated with an injection of leukocyte and platelet rich plasma.
Active Comparator: Botox Group; Patients randomized to this group will be treated with an injection of Type A Botulinum Toxin (Xeomin®, MERZ). Intervention: Botox injection	Drug: Botox injection; Patients will be treated with an injection of Type A Botulinum toxin.; Other Names: Type A Botulinum toxin injection; Xeomin®, MERZ
Active Comparator: Corticoid Group; Patients randomized to this group will be treated with an injection of Corticoids. Intervention: Corticoid injection	Drug: Corticoid injection; Patients will be treated with an injection of Corticoids.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual analog scale (VAS) for pain over the last 24 hours	score varying from 0 to 10	6 months versus Baseline (day 0)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual analog scale for pain over the last 24 hours	score varying from 0 to 10	Baseline (day 0)
Visual analog scale for pain over the last 24 hours	score varying from 0 to 10	3 weeks
Visual analog scale for pain over the last 24 hours	score varying from 0 to 10	6 weeks
Visual analog scale for pain over the last 24 hours	score varying from 0 to 10	3 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Global efficacy	Defined as the proportion of patients for whom a decrease in visual analog scales for pain over the last 24 hours of at least 25% has been observed over the past 6 months.	6 months
VAS for pain after a Jamar grip test	score varying from 0 to 10	Baseline (day 0)
VAS for pain after a Jamar grip test	score varying from 0 to 10	3 months
VAS for pain after a Jamar grip test	score varying from 0 to 10	6 months
PRTEE Score	The Patient-Rated Tennis Elbow Evaluation	Baseline (day 0)
PRTEE Score	The Patient-Rated Tennis Elbow Evaluation	3 months
PRTEE Score	The Patient-Rated Tennis Elbow Evaluation	6 months
Patient Global Impression of Change	score varying from 1 to 7	3 months
Patient Global Impression of Change	score varying from 1 to 7	6 months
Number of patients with adverse effects		Baseline (day 0)
Number of patients with adverse effects		3 weeks
Number of patients with adverse effects		6 weeks
Number of patients with adverse effects		3 months
Number of patients with adverse effects		6 months
The SF 12 questionnaire		3 months
The SF 12 questionnaire		6 months
The consumption of analgesics.		Baseline (day 0)
The consumption of analgesics.		3 weeks
The consumption of analgesics.		6 weeks
The consumption of analgesics.		3 months
The consumption of analgesics.		6 months

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nīmes
• Investigators: Study Director: Matthieu Vaucher, MD, Centre Hospitalier Universitaire de Nīmes

Study record dates

Study Major Dates

• Study Start (Actual): December 17, 2015
• Primary Completion (Actual): May 2, 2017
• Study Completion (Actual): May 2, 2017

Study Registration Dates

• First Submitted: December 19, 2014
• First Submitted That Met QC Criteria: December 23, 2014
• First Posted (Estimated): December 24, 2014

Study Record Updates

• Last Update Posted (Estimated): December 10, 2025
• Last Update Submitted That Met QC Criteria: December 3, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Elbow Tendinopathy; Elbow Injuries; Musculoskeletal Diseases; Muscular Diseases; Wounds and Injuries; Tendon Injuries; Arm Injuries; Tendinopathy; Tennis Elbow; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Hydrolases; Enzymes; Enzymes and Coenzymes; Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Metalloproteases; Bacterial Proteins; Bacterial Toxins; Toxins, Biological; Botulinum Toxins, Type A; incobotulinumtoxinA; Adrenal Cortex Hormones
• Other Study ID Numbers: PHRC-I/2013/MV-01; 2014-001300-22 (EudraCT Number)