Lateral epicondylitis of the elbow MedDRA version: 8.1 Level: LLT Classification code 10024032 Term: Lateral epicondylitis
Conditions
Interventions
Trade Name: Kenacort-T
Pharmaceutical Form: Injection*
Pharmaceutical form of the placebo: Injection*
Route of administration of the placebo: Intralesional use
Sponsors
University of Oslo, Institute of General Practice and Community Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
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 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 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 extensor muscle of the wrist (Cyriax type IV) 9. Treament 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 aquired) Cervical radiculopathy or referred pain from neck or shoulder Previous fractures or tendon ruptures in the elbow Study protocol lateral epicondylitis version 18.04.2006 Page 4 of 6 Systemic musculoskeletal disease Previous allergic reactions to corticosteroids or lidocain 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, SLE, severe liver- or kidney-disease, heart failure, diabetes, use of warfarin or NSAIDS Pregnancy or breast-feeding Fertile females not on effective birth control Psyco-social or other reasons for not being able to participate throughout the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Objective • 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. • Is this outcome influenced by corticosteroid injection, which has been shown to be of benefit alone in the short term?;Secondary Objective: ;Primary end point(s): The patient's evaluation of improvement after 6, 12, 26 and 52 weeks. Pain, function and severity of main complaint after 6, 12, 26 and 52 weeks as recorded by the study doctors. The patient's satisfaction with the treatment. Time off work. | — |
Countries
Norway
Outcome results
None listed