Evaluation of Three Types of Injection for the Treatment of Lateral Epicondylalgia

NCT02325063 | Terminated DMC

• 2 other identifiers: PHRC-I/2013/MV-012014-001300-22
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Epicondylitis, Lateral Humeral; Tennis Elbow

Outcome Measures

Primary Outcomes (1)

• Visual analog scale (VAS) for pain over the last 24 hours

  score varying from 0 to 10

  6 months versus Baseline (day 0)

Secondary Outcomes (4)

• Visual analog scale for pain over the last 24 hours

  Baseline (day 0)

• Visual analog scale for pain over the last 24 hours

  3 weeks

• Visual analog scale for pain over the last 24 hours

  6 weeks

• Visual analog scale for pain over the last 24 hours

  3 months

Other Outcomes (21)

• Global efficacy

  6 months

• VAS for pain after a Jamar grip test

  Baseline (day 0)

• VAS for pain after a Jamar grip test

  3 months

Study Arms (3)

PRP-L Group

EXPERIMENTAL

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

Botox Group

ACTIVE COMPARATOR

Patients randomized to this group will be treated with an injection of Type A Botulinum Toxin (Xeomin®, MERZ). Intervention: Botox injection

Drug: Botox injection

Corticoid Group

ACTIVE COMPARATOR

Patients randomized to this group will be treated with an injection of Corticoids. Intervention: Corticoid injection

Drug: Corticoid injection

Interventions

PRP-L Injection DRUG

Patients will be treated with an injection of leukocyte and platelet rich plasma.

PRP-L Group

Botox injection DRUG

Patients will be treated with an injection of Type A Botulinum toxin.

Also known as: Type A Botulinum toxin injection, Xeomin®, MERZ

Botox Group

Corticoid injection DRUG

Patients will be treated with an injection of Corticoids.

Corticoid Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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
• The patient is participating in another 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
• 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).

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nīmes: lead

Study Sites (2)

CHRU de Montpellier - Hôpital Lapeyronie

Montpellier, 34295, France

Location

CHRU de Nîmes - Hôpital Universitaire Carémeau

Nîmes, 30029, France

Location

MeSH Terms

Conditions

Tennis Elbow

Interventions

Botulinum Toxins, Type A; incobotulinumtoxinA; Adrenal Cortex Hormones

Condition Hierarchy (Ancestors)

Elbow Tendinopathy; Tendinopathy; Muscular Diseases; Musculoskeletal Diseases; Elbow Injuries; Arm Injuries; Wounds and Injuries; Tendon Injuries

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Matthieu Vaucher, MD

  Centre Hospitalier Universitaire de Nîmes

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2014
• First Posted: December 24, 2014
• Study Start: December 17, 2015
• Primary Completion: May 2, 2017
• Study Completion: May 2, 2017
• Last Updated: December 10, 2025

Record last verified: 2025-12

Locations

FR (2)