Treatment Study of Steroid Injection and Physical Therapy for Acute Lateral Epicondylitis (NCT00826462) | Clinical Trial Compass
CompletedPhase 4
Treatment Study of Steroid Injection and Physical Therapy for Acute Lateral Epicondylitis
Norway177 participantsStarted 2009-03
Plain-language summary
The purpose of this study is to compare the clinical effect of physiotherapy alone or combined with corticosteroid injection in the initial treatment of lateral epicondylitis in a primary care setting.
To find the short and long term effect of physiotherapy with Mill's manipulation, deep friction massage and exercise therapy.
To ascertain wether the outcome is influenced by corticosteroid injection, which has been shown to be of benefit alone in the short term?
Who can participate
Age range
18 Years – 70 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:
* Age 18-70 years
* Pain from the lateral part of the elbow
* The pain increases on resisted dorsiflexion of the wrist with the elbow extended and the fingers flexed or the pain increases on resisted radial deviation of the wrist or the pain increases on resisted extension of the 3. finger
Exclusion Criteria:
* Duration of complaints less than 2 weeks or more than 3 months
* The tenderness is located within the muscle body itself in the proximal part of the short radial extensors muscle of the wrist (Cyriax type IV)9.
* Treatment within the last 12 months for the same condition with corticosteroid injection or physiotherapy
* Bilateral complaints
* Previous surgical treatment for lateral epicondylitis
* Deformities of the elbow (congenital or acquired)
* Cervical radiculopathy or referred pain from neck or shoulder
* Previous fractures or tendon ruptures in the elbow
* Systemic musculoskeletal disease
* Previous allergic reactions to corticosteroids or lidocaine
* Contraindications to corticosteroids or NSAIDs:
* On-going or previous gastro-intestinal bleeding
* previous ulcer or dyspepsia, severe asthma
* on-going systemic infection
* local skin-infection
* recently vaccinated with live virus
* coagulopathies
* systemic lupus erythematodes
* severe liver- or kidney-disease
* heart failure
* diabetes
* use of warfarin or NSAIDS
* Pregnancy or breast-feeding
* Fertile females not on effective birth control
* Psycho-social or other …
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.