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

Primary Purpose

Epicondylitis

Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Injection, botulinum toxin + corticoid
Injection, placebo of toxin + corticoid
Injection, botulinum toxin + placebo corticoid
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Epicondylitis focused on measuring Epicondylitis, Botulinum toxin, Corticoid

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Service de Médecine Physique et de Réadaptation, Hôpital Raymond Poincaré

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Active Comparator

Arm Label

Group A : Association (botulinum toxin + corticoid)

Group C : placebo of toxin + corticoid :

Group T : botulinum toxin + placebo corticoid

Arm Description

Outcomes

Primary Outcome Measures

Variation of pain intensity between injection of treatment and 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 Visual Analogue Scale (VAS).
Variation of pain intensity between injection of treatment and 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

Spontaneous pain intensity at rest
Evaluate pain intensity at rest with the VAS.
Pain intensity of motion of wrist flexion
Evaluate pain intensity of motion of wrist flexion with the VAS.
Pain intensity at proximal insertion palpation on epicondylitis muscle
Evaluate pain intensity at proximal insertion palpation on epicondylitis muscle. The palpation will be under ultrasound control.
Number of days of sick leave
Number of days of sick leave will be noted and collected
The percentage of patients returning to professional activity or sportive activity
Measurement of prehensile grasp capabilities by a force
The force will be measured by Jamar Hydraulic hand dynamometer.
Functional outcome after injection
Outcome will be evaluated by questionnaire Patient Rated Tennis Elbow Evaluation
Anxiety and depression tests
Hospital Anxiety and Depression scale will be used
Frequence and gravity of adverse events
Adverse events will be collected and their severity will be reported.

Full Information

First Posted
December 11, 2017
Last Updated
September 19, 2023
Sponsor
Assistance Publique - Hôpitaux de Paris
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1. Study Identification

Unique Protocol Identification Number
NCT03380559
Brief Title
A Phase III Study to Evaluate Efficacy of Botulinum Toxin for Treating Epicondylitis
Acronym
EPITOX
Official Title
A Phase III Randomized Double-blind Study to Evaluate Efficacy of Botulinum Toxin for Treating Epicondylitis
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
April 19, 2019 (Actual)
Primary Completion Date
July 7, 2021 (Actual)
Study Completion Date
August 19, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epicondylitis
Keywords
Epicondylitis, Botulinum toxin, Corticoid

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Ratio 1:1:1
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
33 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group A : Association (botulinum toxin + corticoid)
Arm Type
Experimental
Arm Title
Group C : placebo of toxin + corticoid :
Arm Type
Placebo Comparator
Arm Title
Group T : botulinum toxin + placebo corticoid
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Injection, botulinum toxin + corticoid
Intervention Description
Intramuscular injection of botulinum toxin (Xeomin® 50 U) under ultrasound control Subcutaneous injection (lateral epicondylitis side) of corticoid (2 ml of Hydrocortancyl® 2,5 %)
Intervention Type
Drug
Intervention Name(s)
Injection, placebo of toxin + corticoid
Intervention Description
Intramuscular injection of placebo botulinum toxin (2 ml) under ultrasound control Subcutaneous injection (lateral epicondylitis side) of corticoid (2 ml of Hydrocortancyl® 2,5 %)
Intervention Type
Drug
Intervention Name(s)
Injection, botulinum toxin + placebo corticoid
Intervention Description
Intramuscular injection of botulinum toxin (Xeomin® 50 U) under ultrasound control Subcutaneous injection (lateral epicondylitis side) of placebo of corticoid (2 ml of physiological saline solution NaCL 0.9 %)
Primary Outcome Measure Information:
Title
Variation of pain intensity between injection of treatment and 6 months after injection
Description
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).
Time Frame
At the moment of injection
Title
Variation of pain intensity between injection of treatment and 6 months after injection
Description
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.
Time Frame
6 months after injection
Secondary Outcome Measure Information:
Title
Spontaneous pain intensity at rest
Description
Evaluate pain intensity at rest with the VAS.
Time Frame
Before injection, 3 months after injection and 6 months after injection
Title
Pain intensity of motion of wrist flexion
Description
Evaluate pain intensity of motion of wrist flexion with the VAS.
Time Frame
Before injection, 3 months after injection and 6 months after injection
Title
Pain intensity at proximal insertion palpation on epicondylitis muscle
Description
Evaluate pain intensity at proximal insertion palpation on epicondylitis muscle. The palpation will be under ultrasound control.
Time Frame
Before injection, 3 months after injection and 6 months after injection
Title
Number of days of sick leave
Description
Number of days of sick leave will be noted and collected
Time Frame
6 months after injection
Title
The percentage of patients returning to professional activity or sportive activity
Time Frame
6 months after injection
Title
Measurement of prehensile grasp capabilities by a force
Description
The force will be measured by Jamar Hydraulic hand dynamometer.
Time Frame
At baseline, 3 months after injection, 6 months after injection
Title
Functional outcome after injection
Description
Outcome will be evaluated by questionnaire Patient Rated Tennis Elbow Evaluation
Time Frame
At baseline, 3 months after injection, 6 months after injection
Title
Anxiety and depression tests
Description
Hospital Anxiety and Depression scale will be used
Time Frame
At baseline, 3 months after injection, 6 months after injection
Title
Frequence and gravity of adverse events
Description
Adverse events will be collected and their severity will be reported.
Time Frame
At baseline, 3 months after injection, 6 months after injection

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
François Genêt, MD, PhD
Organizational Affiliation
Service de Médecine Physique et de Réadaptation Hôpital Raymond Poincaré
Official's Role
Study Chair
Facility Information:
Facility Name
Service de Médecine Physique et de Réadaptation, Hôpital Raymond Poincaré
City
Garches
State/Province
Hauts-de-Seine
ZIP/Postal Code
92380
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

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

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