Epicondylitis, Lateral HumeralLETNCT02325063
Evaluation of Three Types of Injection for the Treatment of Lateral Epicondylalgia
A study testing PRP-L Injection, Botox injection and Corticoid injection in people with Epicondylitis, Lateral Humeral and Tennis Elbow, run by Centre Hospitalier Universitaire de Nīmes at 2 sites in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Epicondylitis, Lateral Humeral, Tennis Elbow
- What is being tested?
- PRP-L Injection, Botox injection and Corticoid injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 2 sitesFrance
- Study dates
- 17 Dec 2015to 2 May 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
2 sites in 1 country.
France2 sites
CHRU de Montpellier - Hôpital Lapeyronie
Montpellier, 34295
CHRU de Nîmes - Hôpital Universitaire Carémeau
Nîmes, 30029
About this study
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
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.
Read the 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
- Being tested
- PRP-L Injection, Botox injection, Corticoid injection
- Medical subject headings
- Tennis Elbow
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRP-L InjectionDrug
Patients will be treated with an injection of leukocyte and platelet rich plasma.
Botox injectionDrug
Also called Type A Botulinum toxin injection, Xeomin®, MERZ
Patients will be treated with an injection of Type A Botulinum toxin.
Corticoid injectionDrug
Patients will be treated with an injection of Corticoids.
| Study group | Role | What they receive |
|---|---|---|
| PRP-L Group | Experimental | Patients randomized to this group will be treated with an injection of Leukocyte and Platelet Rich Plasma (PRP-L).
Intervention: PRP-L Injection Receives: Drug: PRP-L Injection |
| Botox Group | Active comparator | Patients randomized to this group will be treated with an injection of Type A Botulinum Toxin (Xeomin®, MERZ).
Intervention: Botox injection Receives: Drug: Botox injection |
| Corticoid Group | Active comparator | Patients randomized to this group will be treated with an injection of Corticoids.
Intervention: Corticoid injection Receives: Drug: Corticoid injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual analog scale (VAS) for pain over the last 24 hours
score varying from 0 to 10
Measured: 6 months versus Baseline (day 0)
Secondary outcomes (4)
Visual analog scale for pain over the last 24 hours
score varying from 0 to 10
Measured: Baseline (day 0)
Visual analog scale for pain over the last 24 hours
score varying from 0 to 10
Measured: 3 weeks
Visual analog scale for pain over the last 24 hours
score varying from 0 to 10
Measured: 6 weeks
Visual analog scale for pain over the last 24 hours
score varying from 0 to 10
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2014 (estimated)
- Study start17 Dec 2015
- Primary completion2 May 2017
- Study completion2 May 2017
Why it stopped: Discontinuation of production of the investigational medicinal product (PRP)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Epicondylitis, Lateral HumeralStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Matthieu Vaucher, MD, Study director, Centre Hospitalier Universitaire de Nīmes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02325063
- Sponsor's protocol ID
- PHRC-I/2013/MV-01
- Other IDs
- 2014-001300-22, 2014
- Acronym
- LET
- Status last verified
- Dec 2025
- First submitted
- 19 Dec 2014
- Last updated
- 10 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02325063
- Acronym / sponsor ID
- LET / PHRC-I/2013/MV-01
- Conditions
- Epicondylitis, Lateral Humeral, Tennis Elbow
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Discontinuation of production of the investigational medicinal product (PRP)
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- 17 Dec 2015 (actual)
- Primary completion
- 2 May 2017 (actual)
- Study completion
- 2 May 2017 (actual)
- First posted
- 24 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| PRP-L Group | Experimental | Drug: PRP-L InjectionPatients randomized to this group will be treated with an injection of Leukocyte and Platelet Rich Plasma (PRP-L). Intervention: PRP-L Injection |
| Botox Group | Active comparator | Drug: Botox injectionPatients randomized to this group will be treated with an injection of Type A Botulinum Toxin (Xeomin®, MERZ). Intervention: Botox injection |
| Corticoid Group | Active comparator | Drug: Corticoid injectionPatients randomized to this group will be treated with an injection of Corticoids. Intervention: Corticoid injection |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PRP-L InjectionPatients will be treated with an injection of leukocyte and platelet rich plasma. | Drug | PRP-L Group |
| Botox injectionAlso: Type A Botulinum toxin injection, Xeomin®, MERZPatients will be treated with an injection of Type A Botulinum toxin. | Drug | Botox Group |
| Corticoid injectionPatients will be treated with an injection of Corticoids. | Drug | Corticoid Group |
Primary outcome
Visual analog scale (VAS) for pain over the last 24 hours
Time frame: 6 months versus Baseline (day 0)
score varying from 0 to 10
4 secondary outcomes
Visual analog scale for pain over the last 24 hours
Time frame: Baseline (day 0)
Visual analog scale for pain over the last 24 hours
Time frame: 3 weeks
Visual analog scale for pain over the last 24 hours
Time frame: 6 weeks
Visual analog scale for pain over the last 24 hours
Time frame: 3 months
Results and safety
The study was stopped early (reason given: Discontinuation of production of the investigational medicinal product (PRP)). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2025.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matthieu Vaucher, MD study director
Centre Hospitalier Universitaire de Nīmes
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PRP-L Injection, Botox injection and Corticoid injection in people with Epicondylitis, Lateral Humeral and Tennis Elbow, run by Centre Hospitalier Universitaire de Nīmes at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 10 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Discontinuation of production of the investigational medicinal product (PRP)). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual analog scale (VAS) for pain over the last 24 hours (time frame: 6 months versus Baseline (day 0)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2025.