Treatment Study of Steroid Injection and Physical Therapy for Acute Lateral Epicondylitis
Condition: Tennis Elbow; Epicondylitis, Lateral Humeral
MeSH terms: Tennis Elbow
Intervention: triamcinolone; Placebo; Lidocaine; Physiotherapy; Naproxen
Intervention description: 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
Intervention MeSH terms: Triamcinolone; Triamcinolone Acetonide; Triamcinolone hexacetonide; Naproxen; Lidocaine; Triamcinolone diacetate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 177.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Randomised; Placebo-controlled; double blind; Intervention study; Primary health care

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?
    

Eligibility 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

        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 reasons for not being able to participate throughout the study.