We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00930709
First Posted: June 30, 2009
Last Update Posted: December 31, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Aki Vainionpaa, Seinajoki Central Hospital
June 29, 2009
June 30, 2009
December 31, 2014
March 2009
December 2014   (Final data collection date for primary outcome measure)
  • Pain, 100 mm visual analogue scale, change from baseline [ Time Frame: 0, 6, 13, 26, 39, 52 weeks ]
  • Grip strength (pain free and maximal), hydraulic hand dynamometer, change from baseline [ Time Frame: 0, 6, 13, 26, 39, 52 weeks ]
  • Pain, 100 mm visual analogue scale [ Time Frame: 0, 6, 13, 26, 39, 52 weeks ]
  • General improvement, 7-point Likert scale [ Time Frame: 0, 6, 13, 26, 39, 52 weeks ]
  • Grip strength, hydraulic hand dynamometer [ Time Frame: 0, 6, 13, 26, 39, 52 weeks ]
Complete list of historical versions of study NCT00930709 on ClinicalTrials.gov Archive Site
  • Experienced disability, 100 mm visual analogue scale, change from baseline [ Time Frame: 0, 6, 13, 26, 39, 52 weeks ]
  • Isometric wrist extension and flexion strength, digital hanging scale with rigid bench frame, change from baseline [ Time Frame: 0, 6, 13, 26, 39, 52 weeks ]
  • Treatment adverse effects [ Time Frame: 0, 6, 13, 26, 39, 52 weeks ]
  • Economic evaluation of interventions, direct and indirect costs [ Time Frame: 0, 6, 13, 26, 39, 52 weeks ]
  • Days in sick leave [ Time Frame: 0, 6, 13, 26, 39, 52 weeks ]
  • Experienced forearm pain and disability, The Patient-Rated Tennis Elbow Evaluation (PRTEE) [ Time Frame: 0, 6, 13, 26, 39, 52 weeks ]
  • General improvement, 7-point Likert scale [ Time Frame: 0, 6, 13, 26, 39, 52 weeks ]
  • Experienced disability, 100 mm visual analogue scale [ Time Frame: 0, 6, 13, 26, 39, 52 weeks ]
  • Isometric wrist extension and flexion strength, digital hanging scale with rigid bench frame [ Time Frame: 0, 6, 13, 26, 39, 52 weeks ]
  • Treatment adverse effects [ Time Frame: 0, 6, 13, 26, 39, 52 weeks ]
  • Economic evaluation of interventions, direct and indirect costs [ Time Frame: 0, 6, 13, 26, 39, 52 weeks ]
  • Days in sick leave [ Time Frame: 0, 6, 13, 26, 39, 52 weeks ]
  • Experienced forearm pain and disability, The Patient-Rated Tennis Elbow Evaluation (PRTEE) [ Time Frame: 0, 6, 13, 26, 39, 52 weeks ]
Not Provided
Not Provided
 
Botulinum Toxin Versus Active Strength Training in the Treatment of Lateral Epicondylitis
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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
  • Epicondylitis, Lateral Humeral
  • Tennis Elbow
  • 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.
    Other Names:
    • Botox®, Allergan
    • NDC 0023-1145-01
  • 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.
    Other Name: Eccentric strength training
  • Active Comparator: Active strength training and stretching
    Active strength training and stretching
    Intervention: Behavioral: Active strength training and stretching
  • Active Comparator: Botulinum toxin type A injections
    Botulinum toxin type A injections
    Intervention: Drug: Botulinum toxin type A (Botox®, Allergan)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
103
December 2014
December 2014   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
20 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Finland
 
 
NCT00930709
EVO1122
2009-009837-14 ( EudraCT Number )
No
Not Provided
Not Provided
Aki Vainionpaa, Seinajoki Central Hospital
Seinajoki Central Hospital
Not Provided
Principal Investigator: Aki Vainionpää, M.D., Ph.D. Department of Physical Medicine and Rehabilitation, Seinäjoki Central Hospital
Seinajoki Central Hospital
December 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP