Botulinum Toxin Versus Active Strength Training in the Treatment of Lateral Epicondylitis
Condition: Epicondylitis, Lateral Humeral; Tennis Elbow
MeSH terms: Tennis Elbow
Study type: Interventional

Summary: 
      The purpose of this study is to compare efficacy, feasibility and cost effectiveness of
      botulinum toxin type A injections to active nine weeks strength training and stretching
      program in the treatment of the chronic lateral epicondylitis.

      The main hypothesis is that the botulinum toxin type A injections may enable more rapid pain
      relief while strength training may provide better functional results and less relapses during
      the follow-up.
    

Detailed description: 
      INTRODUCTION:

      Lateral epicondylitis (tennis elbow) is a frequent repetitive stress injury, affecting the
      common extensor muscles at the lateral humeral epicondyle. Lateral epicondylitis has a
      well-known spontaneous healing tendency. Still the prevalence of the chronic lateral
      epicondylitis is 1.4% in working populations causing significant occupational disability and
      financial burden.

      Systematic reviews of the effectiveness of different treatment modalities for lateral
      epicondylitis present conflicting results. There are no consistent guidelines for management
      of the prolonged lateral epicondylitis. Progressive strengthening and stretching exercises as
      well as botulinum toxin type A injections have been suggested to be effective in treatment of
      chronic cases. However, there are only a few studies comparing different treatment modalities
      and botulinum toxin treatment have not been included in any of these.

      The purpose of this study is to compare efficacy, feasibility and cost effectiveness of the
      botulinum toxin type A injections to active nine weeks strength training and stretching
      program in the treatment of the chronic lateral epicondylitis.

      The main hypothesis is that the botulinum toxin type A injections may enable more rapid pain
      relief while strength training may provide better functional results and less relapses during
      the follow-up.

      SUBJECTS AND METHODS:

      A sample size of 120 participants with an equal drop-out rate of 15 % per group was
      determined in advance to detect a clinically significant 30 percentage points difference in
      outcome measures between the treatment groups with the minimum success rate of 65 % at the
      statistical significance level of 0.05 and power of 80 %.

      During the recruitment process all patient newly referred to Department of PM&R outpatient
      clinics in the Seinäjoki Central Hospital due to elbow pain are evaluated by the study
      investigators. Every eligible patient with written informed consent is recruited. A
      computerised random number generator is used to draw up an allocation schedule. Patients are
      allocated in treatment groups via opaque sealed envelopes marked according to the random
      schedule.

      Measurements and training instructions are performed by five trained physical therapists. In
      addition to detailed personal training instructions given by physical therapist, illustrated
      instructions as well as instruction video will be provided for patients in the training
      group. Physical therapists instructing patients do not perform any measurements to enable
      blinding of assessor. Measurement devices are calibrated regularly according to the
      manufacturers' recommendations and quality assurance measurements with test weights are
      performed on regular basis.

      The principal statistical analysis will be done on an intention-to-treat basis. Repeated
      measures of ANCOVA and Cox Proportional Hazard Regression are planned to be used as primary
      methods. If there will be relapses, more advanced longitudinal models such as Generalised
      Estimating Equations and Random Coefficient Analysis will be used.
    

Intervention name(s): Botulinum toxin type A (Botox®, Allergan); Active strength training and stretching
Intervention type(s): Drug; Behavioral
Intervention description(s): Two injections of 10-60 units of botulinum toxin type A. Injections are administered with ENMG assisted technique at the baseline and after 13 weeks.; Training duration 9 weeks, intensified every 3 weeks in supervision of physiotherapist. Training program includes progressive, slow, repetitive wrist and forearm stretching, eccentric muscle strengthening, occupational exercises and upper limb neural mobilization training.
Other intervention name(s): Botox®, Allergan; NDC 0023-1145-01; Eccentric strength training
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Botulinum Toxin Type A; Exercise; Randomized Controlled Trial; Muscle Stretching Exercises; Strength Training; Treatment Outcome