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

NCT ID: NCT02325063

Last Updated: 2025-12-10

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-12-17
• Study Completion Date: 2017-05-02

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.

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.

Conditions

Epicondylitis, Lateral Humeral; Tennis Elbow

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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

Group Type: EXPERIMENTAL

PRP-L Injection

Intervention Type: DRUG

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

Botox Group

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

Intervention: Botox injection

Group Type: ACTIVE_COMPARATOR

Botox injection

Intervention Type: DRUG

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

Corticoid Group

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

Intervention: Corticoid injection

Group Type: ACTIVE_COMPARATOR

Corticoid injection

Intervention Type: DRUG

Patients will be treated with an injection of Corticoids.

Interventions

PRP-L Injection

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

Intervention Type: DRUG

Botox injection

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

Intervention Type: DRUG

Corticoid injection

Patients will be treated with an injection of Corticoids.

Intervention Type: DRUG

Other Intervention Names

Type A Botulinum toxin injection; Xeomin®, MERZ

Eligibility Criteria

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

• 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

• 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

• 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.

• 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

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire de Nīmes

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Matthieu Vaucher, MD

Role: STUDY_DIRECTOR

Centre Hospitalier Universitaire de Nîmes

Locations

CHRU de Montpellier - Hôpital Lapeyronie

Montpellier, , France

CHRU de Nîmes - Hôpital Universitaire Carémeau

Nîmes, , France

Countries

France

Other Identifiers

2014-001300-22

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

PHRC-I/2013/MV-01

Identifier Type: -

Identifier Source: org_study_id