Clinical trial NCT02325063: Evaluation of Three Types of Injection for the Treatment of Lateral Epicondylalgia
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Epicondylitis, Lateral Humeral
Tennis Elbow
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2014-12-24
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Visual analog scale (VAS) for pain over the last 24 hours
timeFrame: 6 months versus Baseline (day 0)
Secondary outcomes:
measure: Visual analog scale for pain over the last 24 hours
timeFrame: Baseline (day 0)
measure: Visual analog scale for pain over the last 24 hours
timeFrame: 3 weeks
measure: Visual analog scale for pain over the last 24 hours
timeFrame: 6 weeks
measure: Visual analog scale for pain over the last 24 hours
timeFrame: 3 months
Other outcomes:
measure: Global efficacy
timeFrame: 6 months
measure: VAS for pain after a Jamar grip test
timeFrame: Baseline (day 0)
measure: VAS for pain after a Jamar grip test
timeFrame: 3 months
measure: VAS for pain after a Jamar grip test
timeFrame: 6 months
measure: PRTEE Score
timeFrame: Baseline (day 0)
measure: PRTEE Score
timeFrame: 3 months
measure: PRTEE Score
timeFrame: 6 months
measure: Patient Global Impression of Change
timeFrame: 3 months
measure: Patient Global Impression of Change
timeFrame: 6 months
measure: Number of patients with adverse effects
timeFrame: Baseline (day 0)
measure: Number of patients with adverse effects
timeFrame: 3 weeks
measure: Number of patients with adverse effects
timeFrame: 6 weeks
measure: Number of patients with adverse effects
timeFrame: 3 months
measure: Number of patients with adverse effects
timeFrame: 6 months
measure: The SF 12 questionnaire
timeFrame: 3 months
measure: The SF 12 questionnaire
timeFrame: 6 months
measure: The consumption of analgesics.
timeFrame: Baseline (day 0)
measure: The consumption of analgesics.
timeFrame: 3 weeks
measure: The consumption of analgesics.
timeFrame: 6 weeks
measure: The consumption of analgesics.
timeFrame: 3 months
measure: The consumption of analgesics.
timeFrame: 6 months
Locations:
city: Montpellier
country: France
facility: CHRU de Montpellier - Hôpital Lapeyronie
city: Nîmes Cedex 09
country: France
facility: CHRU de Nîmes - Hôpital Universitaire Carémeau
Study officials:
affiliation: Centre Hospitalier Universitaire de Nîmes
name: Matthieu Vaucher, MD
role: STUDY_DIRECTOR
References: