Botulinum Toxin Versus Active Strength Training in the Treatment of Lateral Epicondylitis

Official Title: “Botulinum Toxin Versus Active Strength Training in Treatment of the Lateral Epicondylitis - A Single-Blinded, Randomized, Controlled Trial”

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.

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(s) in this Clinical Trial

• Drug: Botulinum toxin type A (Botox®, Allergan)
  • 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.
• Behavioral: Active strength training and stretching
  • 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.

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: Active strength training and stretching
• Active Comparator: Botulinum toxin type A injections

Primary Measures

• Pain, 100 mm visual analogue scale
  • Time Frame: 0, 6, 13, 26, 39, 52 weeks
    Safety Issue?: No
• Grip strength (pain free and maximal), hydraulic hand dynamometer
  • Time Frame: 0, 6, 13, 26, 39, 52 weeks
    Safety Issue?: No

Secondary Measures

• Experienced disability, 100 mm visual analogue scale
  • Time Frame: 0, 6, 13, 26, 39, 52 weeks
    Safety Issue?: No
• Isometric wrist extension and flexion strength, digital hanging scale with rigid bench frame
  • Time Frame: 0, 6, 13, 26, 39, 52 weeks
    Safety Issue?: No
• Treatment adverse effects
  • Time Frame: 0, 6, 13, 26, 39, 52 weeks
    Safety Issue?: Yes
• Economic evaluation of interventions, direct and indirect costs
  • Time Frame: 0, 6, 13, 26, 39, 52 weeks
    Safety Issue?: No
• Days in sick leave
  • Time Frame: 0, 6, 13, 26, 39, 52 weeks
    Safety Issue?: No
• Experienced forearm pain and disability, The Patient-Rated Tennis Elbow Evaluation (PRTEE)
  • Time Frame: 0, 6, 13, 26, 39, 52 weeks
    Safety Issue?: No
• General improvement, 7-point Likert scale
  • Time Frame: 0, 6, 13, 26, 39, 52 weeks
    Safety Issue?: No

Inclusion Criteria:

• pain at the lateral side of the elbow over 3 months
• local tenderness on palpation over the lateral epicondyle
• positive Mill's sign
• lateral elbow pain progression on resisted wrist and/or middle finger extension
• involved in working life

Exclusion Criteria:

• bilateral symptoms or simultaneous medial epicondylitis
• verified or suspected cervical radiculopathy or affected limb neuropathy
• congenital or acquired deformities of the elbow
• previous surgery of the elbow
• infection, dislocation, tendon ruptures, or fractures in the area
• systemic musculoskeletal or neurological disorders, incl. rheumatic diseases and fibromyalgia
• allergy, antibodies or other contraindications for botulinum toxin
• severe depression, chronic pain syndrome or somatisation disorder
• ongoing retirement process
• pregnancy or breastfeeding
• current participation in other clinical trials

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 20 Years

Maximum Age for this Clinical Trial: 65 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Seinajoki Central Hospital Other

Overall Clinical Trial Officials and Contacts

Aki Vainionpää, M.D., Ph.D. Principal Investigator Department of Physical Medicine and Rehabilitation, Seinäjoki Central Hospital  

Overall Contact: Aki Vainionpää, M.D., Ph.D. +358-40 545 1942 aki.vainionpaa@oulu.fi

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00930709

Study ID Number: EVO1122

ClinicalTrials.gov Identifier: NCT00930709

Health Authority: Finland: Finnish Medicines Agency

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