E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Chronic lateral humerus epiconcylitis |
Kronisk lateral humerusepikondylit. |
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E.1.1.1 | Medical condition in easily understood language |
Tennis elbow |
Tennisarmbåge. |
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E.1.1.2 | Therapeutic area | Diseases [C] - Musculoskeletal Diseases [C05] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 16.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10024032 |
E.1.2 | Term | Lateral epicondylitis |
E.1.2 | System Organ Class | 100000004863 |
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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 |
To examine whether the transient paralysis of the extensor carpi radialis muscle by botulinum toxin injecton can increase circulation and reduce metabolites such as lactic acid in order to reduce pain without the need for surgery. |
Om den övergående förlamningen av extensor carpi radialis brevis-muskeln genom botulinumtoxin kan åstadkomma en förbättrad cirkulation och reduktion av metaboliter som mjölksyra för att minska smärtan utan att behöva tillgripa en kirurgisk intervention. |
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E.2.2 | Secondary objectives of the trial |
Whether botox treatment results in changes in muscle morpholocy in the extensor carpi radialis muscle and whether those changes are permanent. |
Om botoxbehandling ger muskelmorfologiska förändringar i extensor carpi radialis brevis muskeln och om dessa i så fall är permanenta. |
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E.2.3 | Trial contains a sub-study | Yes |
E.2.3.1 | Full title, date and version of each sub-study and their related objectives |
No separate titles. Sub-studies 1-3 are simultaneous, sub-study 4 separate.
1) Whether the aforementioned treatment results in an improved blood flow, as measured by Laser Doppler technology 3 and 12 months post treatment.
2) Whether the aforementioned treatment results in an improved metabolism and reduced accumulation of lactic acid, as measured by microdialysis 3 and 12 months post treatment.
3) Whether the aforementioned treatment results in an improved arm function and reduced pain, as measured by VAS (pain) and DASH, AROM, COPM and hand strength (funtion) 3 and 12 months post treatment.
4) Whether it is possible to determine treatment efficiacy om a strucural level through muscle biopsies taken 2 weeks prior to as well as 6 hours, 6 weeks and 6 months after treatment and subsequent muscle fibre analysis (fibre types, fibre surfaces, satellite cells, capillaries, receptor expression and analysis of myosin heavy chain) and whether those changes are permanent. |
Inga separata titlar föreligger. Delstudie 1-3 sker simultant, delstudie 4 separat.
1) Om man med beh enl ovan kan åstadkomma förbättrat blodflöde, mätt med laserdopplerteknik 3 och 12 mån efter behandling,
2) Om man med beh enl ovan kan åstadkomma förrbättrad metabolism med reduktion av mjölksyra under behandlingsperioden, mätt med mikrodialys 3 och 12 mån efter behandling,
3) Om man med beh enl ovan kan åstadkomma förbättrad armfunktion och minskad smärta, mätt med VAS (smärta) och DASH, AROM, COPM samt handstyrka (funktion) 3 och 12 mån efter behandling.
4) Om man med hjälp av muskelbiopsi 2 v före botoxinjektion, 6 h efter injektion, 6 v efter injektion, samt 6 månader efter injektion och därpå följande muskelfiberanalyser (fibertyper, fiberytor, satellitceller, kapillärer, receptoruttryck samt analys av myosin heavy chain) avgöra om behandlingen haft effekt på strukturell nivå och om denna eventuella förändring är permanent.
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E.3 | Principal inclusion criteria |
Chronic unilateral epicondylitis, verified by hand surgeon
No or inadequate response to conservative treatment
No treatment the past 6 months
30-55 y.o.
Capable of giving informed consent |
Av handkirurg verifierad kronisk unilateral epikondylit.
Ingen eller otillräcklig effekt av konservativ terapi, dvs. fortsatt besvärande epikondylitstatus verifierat enligt förra punkten.
Ingen behandling de senaste 6 månaderna
30-55 år
Beslutskompetent
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E.4 | Principal exclusion criteria |
Bilateral symptoms
Radial tunnel syndrome
Diabetes Mellitus
Prior surgery in the elbow region
Threatment with beta blockers
Ongoing infection at the site of injection
Allergy or hypersensitivity towards botulinum toxin
Nursing or pregnant females
Participation in other pharmacological study within the last 12 months or where the follow-up time is not yet concluded. |
Bilaterala symptom
Radialtunnelsyndrom
Diabetes Mellitus
Tidigare kirurgiska ingrepp i armbågsregionen
Behandling med betablockerande läkemedel
Aktuell infektion vid insticksstället
Allergi eller överkänslighet mot botulinumtoxin
Gravida eller ammande
Deltagande i annan läkemedelsstudie under de senaste 12 månaderna eller där uppföljningstiden ej är avslutad
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E.5 End points |
E.5.1 | Primary end point(s) |
Efficiacy of treatment, measured as recuction of pain according to VAS. |
Behandlingseffekt, mätt som smärtpåverkan enligt VAS |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
3 and 12 months post treatment |
3 och 12 månader efter behandling |
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E.5.2 | Secondary end point(s) |
Efficiacy of treatment, measured as:
a: Function according to DASH, AROM etc.
b: Blood flow as measured by Laser Doppler
c: Accumulation of metabolites (e.g. lactic acid), measured by microdialysis
d: Properties of biopsies |
Behandlingseffekt, mätt som:
a) Funktion enligt bl.a. DASH och AROM
b) Blodflöde, mätt med laserdoppler
c) Ansamling av metaboliter (t.ex. mjölksyra) mätt med mikrodialys
d) Egenskaper hos biopsier
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
a/b/c: 3 and 12 months post treatment
d: 6 hours, 6 weeks and 6 months post treatment |
a/b/c) 3 och 12 månader efter behandling
d) 6 timmar, 6 veckor och 6 månader efter behandling.
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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 | Yes |
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) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
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 | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
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 | No |
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
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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 | |
E.8.9.1 | In the Member State concerned days | |