E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Lateral epicondylitis |
Lateraalinen epikondyliitti |
|
E.1.1.1 | Medical condition in easily understood language |
Lateral epicondylitis / tennis elbow |
Tenniskyynärpää |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Musculoskeletal Diseases [C05] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
Objective of the trial is to compare the effectiveness of injected levobupivacaine and liposomal bupivacaine in the treatment of pain and disability in patients with lateral epicondylitis. |
Tutkimuksen tarkoituksena on verrata levobupivakaiinin ja lipsosomaalisen bupivakaiinin (Exparel) vaikuttavuutta tenniskyynärpäähän liittyvän kivun ja toimintakyvyn vajauksen hoidossa. |
|
E.2.2 | Secondary objectives of the trial |
Not applicable |
Ei käytössä |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
-age 18-65 -employed -chronic lateral epicondylitis (duration >3 months) -pain in lateral epicondyle -pain in resisted wrist extension in elbow extension (Cozen test) -X-ray or Magnetic resonance imaging (MRI) of the elbow (<12 months from enrollment) with no pathological findings other than lateral epicondylitis
|
-18-65 vuoden ikä -työllistetty -krooninen tenniskyynärpää (oireet yli 3 kuukautta) -Kipu vastustetussa ranteen ojennuksessa kyynärpää suorana (Cozenin testi) -Tuore (<12kk) röntgen tai magneettikuva kyynärpäästä, jossa ei todeta muita patologisia muutoksia kuin tenniskyynärpään löydökset
|
|
E.4 | Principal exclusion criteria |
-pregnancy -unemployment -allergy to levobupivacaine, bupivacaine or liposomal bupivacaine -constant use of strong analgesics (e.g. opioids) -other source of elbow pain (e.g. medial epicondylitis, distal biceps/triceps tendinitis) -bilateral epicondylitis -inability to give informed consent -inability to understand the enrollment forms or to fill patient diary (forms are written in Finnish) -previous injection treatment (e.g. cortisone, botulin toxin A, autologous plasma) for lateral epicondylitis during the past 3 months -severe hepatic disease, or other underlying severe illness (cardiac failure, cancer, other systemic diseases)
|
-raskaus -työttömyys -allergia (levobupivakaiini, bupivakaiini tai liposomaalinen bupivakaiini) -vahvojen kipulääkkeiden käyttö pitkäaikainen käyttö - kyynärpääkivun muut lähteet - bilateraalinen epikondyliitti - ei pysty antaa suostumusta tutkimukseen - ei pysty täyttämään tai vastaamaan tutkimuskaavakkeisiin - saanut injektiohoidon kyynärpääkipuun viimeisen 3kk sisällä - Tutkittavalla vakava sairaus |
|
E.5 End points |
E.5.1 | Primary end point(s) |
reduction in pain reported by VAS |
Kivun lievitys mitattuna VAS asteikolla |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
D0: before injection therapy 1 week 1 month
Repeated for the second treatment |
Päivä 0: ennen injektiohoitoa 1 viikko 1 kuukausi
Tositetaan toiselle hoidolle |
|
E.5.2 | Secondary end point(s) |
Oxford Elbow Score (OES) QuickDash time off work due to epicondylagia in days reduction in consumption of pain medication |
Oxford Elbow Score (OES) QuickDash Poissaolopäivät töistä kivun vuoksi Kipulääkkeiden käytön vähentyminen |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
D0: before injection therapy 1 week 1 month
Repeated for the second treatment |
Päivä 0: ennen injektiohoitoa 1 viikko 1 kuukausi
Tositetaan toiselle hoidolle |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | Yes |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
LVLS |
Viimeisen tutkittavan viimeinen käynti |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |