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

Tennis Elbow Clinical Trial

— LET  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02325063
• Other study ID #: PHRC-I/2013/MV-01
• Secondary ID: 2014-001300-22
• Status: Terminated
• Phase: N/A
• First received: December 19, 2014
• Last updated: June 16, 2017
• Start date: December 17, 2015
• Est. completion date: May 2, 2017

Study information

• Verified date: June 2017
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 13
• Est. completion date: May 2, 2017
• Est. primary completion date: May 2, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Epicondylitis, Lateral Humeral
• Tennis Elbow

Intervention

Drug:
• PRP-L Injection
Patients will be treated with an injection of leukocyte and platelet rich plasma.
• Botox injection
Patients will be treated with an injection of Type A Botulinum toxin.
• Corticoid injection
Patients will be treated with an injection of Corticoids.

Locations

Country	Name	City	State
France	CHRU de Montpellier - Hôpital Lapeyronie	Montpellier
France	CHRU de Nîmes - Hôpital Universitaire Carémeau	Nîmes Cedex 09

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Global efficacy	Defined as the proportion of patients for whom a decrease in visual analog scales for pain over the last 24 hours of at least 25% has been observed over the past 6 months.	6 months
Other	VAS for pain after a Jamar grip test	score varying from 0 to 10	Baseline (day 0)
Other	VAS for pain after a Jamar grip test	score varying from 0 to 10	3 months
Other	VAS for pain after a Jamar grip test	score varying from 0 to 10	6 months
Other	PRTEE Score	The Patient-Rated Tennis Elbow Evaluation	Baseline (day 0)
Other	PRTEE Score	The Patient-Rated Tennis Elbow Evaluation	3 months
Other	PRTEE Score	The Patient-Rated Tennis Elbow Evaluation	6 months
Other	Patient Global Impression of Change	score varying from 1 to 7	3 months
Other	Patient Global Impression of Change	score varying from 1 to 7	6 months
Other	Number of patients with adverse effects		Baseline (day 0)
Other	Number of patients with adverse effects		3 weeks
Other	Number of patients with adverse effects		6 weeks
Other	Number of patients with adverse effects		3 months
Other	Number of patients with adverse effects		6 months
Other	The SF 12 questionnaire		3 months
Other	The SF 12 questionnaire		6 months
Other	The consumption of analgesics.		Baseline (day 0)
Other	The consumption of analgesics.		3 weeks
Other	The consumption of analgesics.		6 weeks
Other	The consumption of analgesics.		3 months
Other	The consumption of analgesics.		6 months
Primary	Visual analog scale (VAS) for pain over the last 24 hours	score varying from 0 to 10	6 months versus Baseline (day 0)
Secondary	Visual analog scale for pain over the last 24 hours	score varying from 0 to 10	Baseline (day 0)
Secondary	Visual analog scale for pain over the last 24 hours	score varying from 0 to 10	3 weeks
Secondary	Visual analog scale for pain over the last 24 hours	score varying from 0 to 10	6 weeks
Secondary	Visual analog scale for pain over the last 24 hours	score varying from 0 to 10	3 months