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

Tracking Information
First Submitted Date ICMJE	June 29, 2009
First Posted Date ICMJE	June 30, 2009
Last Update Posted Date	December 31, 2014
Study Start Date ICMJE	March 2009
Actual Primary Completion Date	December 2014 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: November 25, 2013)	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 ]
Original Primary Outcome Measures ICMJE; (submitted: June 29, 2009)	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 ]
Change History	Complete list of historical versions of study NCT00930709 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: November 25, 2013)	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 ]
Original Secondary Outcome Measures ICMJE; (submitted: June 29, 2009)	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 ]
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Botulinum Toxin Versus Active Strength Training in the Treatment of Lateral Epicondylitis
Official Title ICMJE	Botulinum Toxin Versus Active Strength Training in Treatment of the Lateral Epicondylitis - A Single-Blinded, Randomized, Controlled Trial
Brief 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.
Study Type ICMJE	Interventional
Study Phase	Not Applicable
Study Design ICMJE	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Outcomes Assessor); Primary Purpose: Treatment
Condition ICMJE	Epicondylitis, Lateral Humeral; Tennis Elbow
Intervention ICMJE	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
Study Arms	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)
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Actual Enrollment ICMJE; (submitted: December 30, 2014)	103
Original Estimated Enrollment ICMJE; (submitted: June 29, 2009)	120
Actual Study Completion Date	December 2014
Actual Primary Completion Date	December 2014 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	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
Sex/Gender	Sexes Eligible for Study: All
Ages	20 Years to 65 Years (Adult)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	Finland
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT00930709
Other Study ID Numbers ICMJE	EVO1122; 2009-009837-14 ( EudraCT Number )
Has Data Monitoring Committee	No
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Aki Vainionpaa, Seinajoki Central Hospital
Study Sponsor ICMJE	Seinajoki Central Hospital
Collaborators ICMJE	Not Provided
Investigators ICMJE	Principal Investigator: Aki Vainionpää, M.D., Ph.D. Department of Physical Medicine and Rehabilitation, Seinäjoki Central Hospital
PRS Account	Seinajoki Central Hospital
Verification Date	December 2014
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP