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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-001300-22 | EudraCT Number |
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Discontinuation of production of the investigational medicinal product (PRP)
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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 |
|
| Corticoid Group | Active Comparator | Patients randomized to this group will be treated with an injection of Corticoids. Intervention: Corticoid injection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PRP-L Injection | Drug | Patients will be treated with an injection of leukocyte and platelet rich plasma. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Visual analog scale (VAS) for pain over the last 24 hours | score varying from 0 to 10 | 6 months versus Baseline (day 0) |
| Measure | Description | Time Frame |
|---|---|---|
| Visual analog scale for pain over the last 24 hours | score varying from 0 to 10 | Baseline (day 0) |
| Visual analog scale for pain over the last 24 hours | score varying from 0 to 10 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| VAS for pain after a Jamar grip test |
General inclusion criteria:
Inclusion criteria for the target population: the patient has a side epicondylalgia objectified by:
General non-inclusion criteria:
Non-inclusion criteria for investigational and auxiliary medicinal products:
Non-inclusion criteria for the medical device used for the PRP samples (SmartPReP2 sampling system):
Non-inclusion criteria for interfering diseases or conditions:
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| Name | Affiliation | Role |
|---|---|---|
| Matthieu Vaucher, MD | Centre Hospitalier Universitaire de Nīmes | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHRU de Montpellier - Hôpital Lapeyronie | Montpellier | 34295 | France | |||
| CHRU de Nîmes - Hôpital Universitaire Carémeau |
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| ID | Term |
|---|---|
| D013716 | Tennis Elbow |
| ID | Term |
|---|---|
| D000070639 | Elbow Tendinopathy |
| D052256 | Tendinopathy |
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D019274 | Botulinum Toxins, Type A |
| C545476 | incobotulinumtoxinA |
| D000305 | Adrenal Cortex Hormones |
| ID | Term |
|---|---|
| D001905 | Botulinum Toxins |
| D008666 | Metalloendopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
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| Botox injection | Drug | Patients will be treated with an injection of Type A Botulinum toxin. |
|
|
| Corticoid injection | Drug | Patients will be treated with an injection of Corticoids. |
|
| 3 weeks |
| Visual analog scale for pain over the last 24 hours | score varying from 0 to 10 | 6 weeks |
| Visual analog scale for pain over the last 24 hours | score varying from 0 to 10 | 3 months |
score varying from 0 to 10
| Baseline (day 0) |
| VAS for pain after a Jamar grip test | score varying from 0 to 10 | 3 months |
| VAS for pain after a Jamar grip test | score varying from 0 to 10 | 6 months |
| PRTEE Score | The Patient-Rated Tennis Elbow Evaluation | Baseline (day 0) |
| PRTEE Score | The Patient-Rated Tennis Elbow Evaluation | 3 months |
| PRTEE Score | The Patient-Rated Tennis Elbow Evaluation | 6 months |
| Patient Global Impression of Change | score varying from 1 to 7 | 3 months |
| Patient Global Impression of Change | score varying from 1 to 7 | 6 months |
| Number of patients with adverse effects | Baseline (day 0) |
| Number of patients with adverse effects | 3 weeks |
| Number of patients with adverse effects | 6 weeks |
| Number of patients with adverse effects | 3 months |
| Number of patients with adverse effects | 6 months |
| The SF 12 questionnaire | 3 months |
| The SF 12 questionnaire | 6 months |
| The consumption of analgesics. | Baseline (day 0) |
| The consumption of analgesics. | 3 weeks |
| The consumption of analgesics. | 6 weeks |
| The consumption of analgesics. | 3 months |
| The consumption of analgesics. | 6 months |
| Nîmes |
| 30029 |
| France |
| D000092464 |
| Elbow Injuries |
| D001134 | Arm Injuries |
| D014947 | Wounds and Injuries |
| D013708 | Tendon Injuries |
| D006867 |
| Hydrolases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D045726 | Metalloproteases |
| D001426 | Bacterial Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D001427 | Bacterial Toxins |
| D014118 | Toxins, Biological |
| D001685 | Biological Factors |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |