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Sponsors and Collaborators: |
University of Oslo Allmennmedisinsk forskningsfond, Norway |
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Information provided by: | University of Oslo |
ClinicalTrials.gov Identifier: | NCT00826462 |
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?
Condition | Intervention | Phase |
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Tennis Elbow Epicondylitis, Lateral Humeral |
Drug: triamcinolone Drug: Placebo Drug: Lidocaine Other: Physiotherapy Drug: Naproxene |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Factorial Assignment, Efficacy Study |
Official Title: | Physiotherapy Alone, in Combination With Corticosteroid Injection or Wait-and-See for Acute Lateral Epicondylitis in General Practice: a Randomised, Placebo-Controlled Study With 12 Months Follow-up |
Estimated Enrollment: | 174 |
Study Start Date: | March 2009 |
Estimated Study Completion Date: | March 2013 |
Estimated Primary Completion Date: | March 2012 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Corticosteroid injection in combination with physical therapy Injection with triamcinolone 10 mg and 10 mg of lidocaine at start and at 3 weeks in combination with physiotherapy for 6 weeks (12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises) Naprosyn Entero 500 mg bid for 14 days |
Drug: triamcinolone
Injection with triamcinolone 10 mg at start and at 3 weeks
Drug: Lidocaine
10 mg of lidocaine at start and at 3 weeks
Other: Physiotherapy
12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises
Drug: Naproxene
Naproxene 500 mg bid for 14 days
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2: Placebo Comparator
Placebo injection in combination with physical therapy Injection with sodium chloride and 10 mg of lidocaine at start and at 3 weeks in combination with physiotherapy for 6 weeks (12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises) Naprosyn entero 500 mg bid for 14 days |
Drug: Placebo
Injection with sodium chloride at start and at 3 weeks
Drug: Lidocaine
10 mg of lidocaine at start and at 3 weeks
Other: Physiotherapy
12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises
Drug: Naproxene
Naproxene 500 mg bid for 14 days
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3: No Intervention
Control group: wait-and-see treatment Naprosyn entero 500 mg bid for 14 days
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Drug: Naproxene
Naproxene 500 mg bid for 14 days
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Much has been written about lateral epicondylitis/tennis elbow reflecting the existence of many treatments for the condition. However, there is no consensus as to which treatment gives the best results.
Based on the latest meta-studies and reviews from the Cochrane Library, one may conclude that there is evidence of a short-term effect of topical or per oral NSAIDs. The same is true for manipulation and exercise. Corticosteroid injection has also been shown to have short-term effect, but not beyond 6 weeks. Ultrasound has a possible short-term effect based on one meta-analysis. Extra corporeal shock wave therapy does not seem to be effective. The treatment with acupuncture, orthosis, surgery or long-term NSAIDs has no support in the literature, and it is impossible to draw any conclusions about the effects or absence thereof. In fact, there is scant support for any long-term treatment in the literature.
We have found two studies to be of special interest (see citations below). Both have been done in a primary care setting with one-year follow up. One study compares corticosteroid injection with physical therapy (ultrasound, manipulation and exercise) and a wait-and-see group. The other compares corticosteroid injection with naproxen orally and placebo-medication. Both conclude that corticosteroid injection is a safe and effective treatment as pain-relief during the first 6 weeks, and that the effect of this treatment is better than physical therapy, wait-and-see and naproxen orally within the same time-frame. Physical therapy in one study gives some, but not statistically significantly better long-term (one year) effect than wait-and-see treatment.
There seems to be some indication that corticosteroid injection is a good alternative for the first 6 weeks. We find there is a good reason to investigate the long-term effects of physical therapy. At the same time, it would be interesting to see whether the good initial response from corticosteroid injection may be extended if combined with physiotherapy.
This randomised, placebo-controlled study will be conducted in general practice in Ostfold County, Norway including patient aged 18-70 years with pain of recent onset from the lateral part of the elbow. After a treatment-period of 6 weeks, the patient is followed for a total of 12 months.
Patients are recruited by interested general practitioners in the city of Sarpsborg and surroundings and remitted to two study-physicians who make the initial evaluation of inclusion- and exclusion criteria, as well as treatment, follow-up and outcome assessments during the whole study-period. The patients are treated by one of the two study-physicians in the 6-weeks treatment-period. From the 6. week, the patient sees the other physician, who is unaware of the allocated intervention, for further registration and assessment.
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contraindications to corticosteroids or NSAIDs:
Contact: Morten Olaussen, M.D. | +4769971530 | moolauss@online.no |
Contact: Oystein Holmedal, M.D. | +4769132082 | oystein.holmedal@getmail.no |
Norway | |
Grålum legesenter | Recruiting |
Sarpsborg, Norway, 1712 | |
Contact: Morten Olaussen, M.D. :+47 908 40 608 moolauss@online.no | |
Contact: Oystein Holmedal, M.D. +4791648100 oystein.holmedal@getmail.no |
Study Chair: | Morten Lindbaek, Ph. D. | University of Oslo |
Responsible Party: | University of Oslo ( Institute of General Practice and Community Medicine, University of Oslo ) |
Study ID Numbers: | 2006-002283-26 |
Study First Received: | January 20, 2009 |
Last Updated: | March 31, 2009 |
ClinicalTrials.gov Identifier: | NCT00826462 History of Changes |
Health Authority: | Norway: Norwegian Medicines Agency |
Randomised Placebo-controlled double blind Intervention study Primary health care |
Anti-Inflammatory Agents Naproxen Immunologic Factors Tennis Elbow Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Wounds and Injuries Lidocaine Central Nervous System Depressants Disorders of Environmental Origin Anesthetics Triamcinolone diacetate |
Cardiovascular Agents Immunosuppressive Agents Hormones Glucocorticoids Arm Injuries Anesthetics, Local Triamcinolone hexacetonide Triamcinolone Acetonide Musculoskeletal Diseases Triamcinolone Anti-Arrhythmia Agents Peripheral Nervous System Agents |
Anti-Inflammatory Agents Molecular Mechanisms of Pharmacological Action Immunologic Factors Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Anesthetics Disorders of Environmental Origin Hormones Arm Injuries Triamcinolone hexacetonide Triamcinolone Acetonide Musculoskeletal Diseases Sensory System Agents Therapeutic Uses Triamcinolone |
Anti-Arrhythmia Agents Tennis Elbow Lidocaine Wounds and Injuries Central Nervous System Depressants Enzyme Inhibitors Triamcinolone diacetate Cardiovascular Agents Immunosuppressive Agents Glucocorticoids Anesthetics, Local Pharmacologic Actions Peripheral Nervous System Agents Central Nervous System Agents |