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A Phase III Study to Evaluate Efficacy of Botulinum Toxin for Treating Epicondylitis (EPITOX)

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ClinicalTrials.gov Identifier: NCT03380559
Recruitment Status : Not yet recruiting
First Posted : December 21, 2017
Last Update Posted : December 21, 2017
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Brief Summary:

The study aims to demonstrate that intramuscular injection of botulinum toxin with a paralyzing dose coupled with subcutaneous injection of corticoid has greater efficacy than corticoid injection only or toxin injection only for treating lateral epicondylitis in reducing pain at 6 months.

As secondary objectives, the study aims to

  • demonstrate improvement of quality of patient's life and positive effect on their resuming to professional activities or sportive activities.
  • evaluate tolerance of treatment by grip strength measurement and adverse event collection.

Condition or disease Intervention/treatment Phase
Epicondylitis Drug: Injection, botulinum toxin + corticoid Drug: Injection, placebo of toxin + corticoid Drug: Injection, botulinum toxin + placebo corticoid Phase 3

Detailed Description:

This is a prospective multicenter phase IIIb randomized double-blind placebo-controlled study, to compare efficacy and tolerance of 3 groups of treatments for epicondylitis.

All patients will be randomized in 3 following parallel treatment groups:

Group A : botulinum toxin + corticoid

Group C : placebo of toxin + corticoid

Group T : botulinum toxin + placebo corticoid

The study will be performed in 4 centers in France, targetting 150 patients. The follow-up of each patient will last 6 months after treatment.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Ratio 1:1:1
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase III Randomized Double-blind Study to Evaluate Efficacy of Botulinum Toxin for Treating Epicondylitis
Estimated Study Start Date : January 2018
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : June 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Steroids

Arm Intervention/treatment
Experimental: Group A : Association (botulinum toxin + corticoid) Drug: Injection, botulinum toxin + corticoid
  • Intramuscular injection of botulinum toxin (Xeomin® 100 U) under ultrasound control
  • Subcutaneous injection (lateral epicondylitis side) of corticoid (2 ml of Hydrocortancyl® 2,5 %)

Placebo Comparator: Group C : placebo of toxin + corticoid : Drug: Injection, placebo of toxin + corticoid
  • Intramuscular injection of placebo botulinum toxin (2 ml) under ultrasound control
  • Subcutaneous injection (lateral epicondylitis side) of corticoid (2 ml of Hydrocortancyl® 2,5 %)

Active Comparator: Group T : botulinum toxin + placebo corticoid Drug: Injection, botulinum toxin + placebo corticoid
  • Intramuscular injection of botulinum toxin (2 ml) under ultrasound control
  • Subcutaneous injection (lateral epicondylitis side) of placebo of corticoid (2 ml of physiological saline solution NaCL 0.9 %)




Primary Outcome Measures :
  1. Variation of pain intensity between injection of treatment and 6 months after injection [ Time Frame: At the moment of injection ]
    Evaluate the variation of muscle pain intensity in wrist extensor contractions between the moment of injection and the end of the 6th month with the Visual Analogue Scale (VAS).

  2. Variation of pain intensity between injection of treatment and 6 months after injection [ Time Frame: 6 months after injection ]
    Evaluate the variation of muscle pain intensity in wrist extensor contractions between the moment of injection and the end of the 6th month with the VAS.


Secondary Outcome Measures :
  1. Spontaneous pain intensity at rest [ Time Frame: Before injection, 3 months after injection and 6 months after injection ]
    Evaluate pain intensity at rest with the VAS.

  2. Pain intensity of motion of wrist flexion [ Time Frame: Before injection, 3 months after injection and 6 months after injection ]
    Evaluate pain intensity of motion of wrist flexion with the VAS.

  3. Pain intensity at proximal insertion palpation on epicondylitis muscle [ Time Frame: Before injection, 3 months after injection and 6 months after injection ]
    Evaluate pain intensity at proximal insertion palpation on epicondylitis muscle. The palpation will be under ultrasound control.

  4. Number of days of sick leave [ Time Frame: 6 months after injection ]
    Number of days of sick leave will be noted and collected

  5. The percentage of patients returning to professional activity or sportive activity [ Time Frame: 6 months after injection ]
  6. Measurement of prehensile grasp capabilities by a force [ Time Frame: At baseline, 3 months after injection, 6 months after injection ]
    The force will be measured by Jamar Hydraulic hand dynamometer.

  7. Functional outcome after injection [ Time Frame: At baseline, 3 months after injection, 6 months after injection ]
    Outcome will be evaluated by questionnaire Patient Rated Tennis Elbow Evaluation

  8. Anxiety and depression tests [ Time Frame: At baseline, 3 months after injection, 6 months after injection ]
    Hospital Anxiety and Depression scale will be used

  9. Frequence and gravity of adverse events [ Time Frame: At baseline, 3 months after injection, 6 months after injection ]
    Adverse events will be collected and their severity will be reported.



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient aged between 18 and 60 years;
  • Physical disability or not;
  • Unilateral lateral epicondylitis more than 3 months, recurrent or not, no response to at least one standard treatment such as: local injection of corticoid, physiotherapy, rest, NSAIDs per os;
  • Signed consent obtained;
  • Covered by health insurance.

Exclusion Criteria:

  • Central nervous system disorders result in spasticity in epicondylitis limb;
  • History of severe psychiatric disorder;
  • History of myasthenia gravis;
  • Pregnant or breastfeeding woman;
  • Unable to understand or respond to questions;
  • Contraindication to botulinum toxin or corticoid;
  • Treatment with botulinum toxin 3 months prior to baseline;
  • Anticoagulant theraphy;
  • Difficult to follow-up in the study;
  • Patient under guardianship, or deprived of liberty by a judicial order.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03380559


Contacts
Contact: François Genêt, MD, PhD + 33 1 47 10 70 68 francois.genet@aphp.fr

Locations
France
Service de Médecine Physique et de Réadaptation, Hôpital Raymond Poincaré Not yet recruiting
Garches, Hauts-de-Seine, France, 92380
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Study Chair: François Genêt, MD, PhD Service de Médecine Physique et de Réadaptation Hôpital Raymond Poincaré

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT03380559     History of Changes
Other Study ID Numbers: P160926J
2017-001709-33 ( EudraCT Number )
First Posted: December 21, 2017    Key Record Dates
Last Update Posted: December 21, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Epicondylitis
Botulinum toxin
Corticoid

Additional relevant MeSH terms:
Tennis Elbow
Elbow Tendinopathy
Tendinopathy
Muscular Diseases
Musculoskeletal Diseases
Arm Injuries
Wounds and Injuries
Tendon Injuries
Botulinum Toxins
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs