Chronic lateral humerus epiconcylitis MedDRA version: 16.0 Level: LLT Classification code 10024032 Term: Lateral epicondylitis System Organ Class: 100000004863
Conditions
Interventions
Trade Name: Dysport
Product Name: botulinum toxin
Pharmaceutical Form: Powder for solution for injection
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the place
Sponsors
Handkirurgiska kliniken, Universitetssjukhuset Örebro
Eligibility
Sex/Gender
All
Inclusion criteria
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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 50 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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.;Secondary Objective: Whether botox treatment results in changes in muscle morpholocy in the extensor carpi radialis muscle and whether those changes are permanent.;Primary end point(s): Efficiacy of treatment, measured as recuction of pain according to VAS.;Timepoint(s) of evaluation of this end point: 3 and 12 months post treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| 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;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 | — |
Countries
Sweden
Contacts
Public ContactHandkirurgiska mottagningen
Handkirurgiska kliniken, Universitetssjukhuset Örebro
Outcome results
None listed