Botulinum Toxin Versus Active Strength Training in the Treatment of Lateral Epicondylitis (NCT00930709) | Clinical Trial Compass
CompletedNot Applicable
Botulinum Toxin Versus Active Strength Training in the Treatment of Lateral Epicondylitis
Finland103 participantsStarted 2009-03
Plain-language summary
The purpose of this study is to compare efficacy, feasibility and cost effectiveness of botulinum toxin type A injections to active nine weeks strength training and stretching program in the treatment of the chronic lateral epicondylitis.
The main hypothesis is that the botulinum toxin type A injections may enable more rapid pain relief while strength training may provide better functional results and less relapses during the follow-up.
Who can participate
Age range
20 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* pain at the lateral side of the elbow over 3 months
* local tenderness on palpation over the lateral epicondyle
* positive Mill's sign
* lateral elbow pain progression on resisted wrist and/or middle finger extension
* involved in working life
Exclusion Criteria:
* bilateral symptoms or simultaneous medial epicondylitis
* verified or suspected cervical radiculopathy or affected limb neuropathy
* congenital or acquired deformities of the elbow
* previous surgery of the elbow
* infection, dislocation, tendon ruptures, or fractures in the area
* systemic musculoskeletal or neurological disorders, incl. rheumatic diseases and fibromyalgia
* allergy, antibodies or other contraindications for botulinum toxin
* severe depression, chronic pain syndrome or somatisation disorder
* ongoing retirement process
* pregnancy or breastfeeding
* current participation in other clinical trials
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Pain, 100 mm visual analogue scale, change from baseline
Timeframe: 0, 6, 13, 26, 39, 52 weeks
2
Grip strength (pain free and maximal), hydraulic hand dynamometer, change from baseline