Treatment Study of Steroid Injection and Physical Therapy for Acute Lateral Epicondylitis
Condition: Tennis Elbow; Epicondylitis, Lateral Humeral
MeSH terms: Tennis Elbow
Study type: Interventional
Phase: Phase 4

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?
    

Detailed description: 
      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 the town
      of Sarpsborg, 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.
    

Intervention name(s): triamcinolone; Placebo; Lidocaine; Physiotherapy; Naproxen
Intervention type(s): Drug; Drug; Drug; Other; Drug
Intervention description(s): Injection with triamcinolone 10 mg at start and at 3 weeks; Injection with sodium chloride at start and at 3 weeks; 10 mg of lidocaine at start and at 3 weeks; 12 treatments with deep friction massage, Mill's manipulation, soft tissue treatment and home exercises; Naproxen 500 mg bid for 14 days
Other intervention name(s): Kenacort - T (triamcinolone); Xylocaine (lidocaine); Sodium chloride; Xylocaine; Physical therapy; Naprosyn entero
Intervention MeSH terms: Triamcinolone; Triamcinolone Acetonide; Triamcinolone hexacetonide; Naproxen; Lidocaine; Triamcinolone diacetate
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Randomised; Placebo-controlled; double blind; Intervention study; Primary health care