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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Aki Vainionpaa, Seinajoki Central Hospital
ClinicalTrials.gov Identifier:
NCT00930709
First received: June 29, 2009
Last updated: November 25, 2013
Last verified: November 2013
  Purpose

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.


Condition Intervention
Epicondylitis, Lateral Humeral
Tennis Elbow
Drug: Botulinum toxin type A (Botox®, Allergan)
Behavioral: Active strength training and stretching

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Botulinum Toxin Versus Active Strength Training in Treatment of the Lateral Epicondylitis - A Single-Blinded, Randomized, Controlled Trial

Resource links provided by NLM:


Further study details as provided by Seinajoki Central Hospital:

Primary Outcome Measures:
  • Pain, 100 mm visual analogue scale, change from baseline [ Time Frame: 0, 6, 13, 26, 39, 52 weeks ] [ Designated as safety issue: No ]
  • Grip strength (pain free and maximal), hydraulic hand dynamometer, change from baseline [ Time Frame: 0, 6, 13, 26, 39, 52 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Experienced disability, 100 mm visual analogue scale, change from baseline [ Time Frame: 0, 6, 13, 26, 39, 52 weeks ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Treatment adverse effects [ Time Frame: 0, 6, 13, 26, 39, 52 weeks ] [ Designated as safety issue: Yes ]
  • Economic evaluation of interventions, direct and indirect costs [ Time Frame: 0, 6, 13, 26, 39, 52 weeks ] [ Designated as safety issue: No ]
  • Days in sick leave [ Time Frame: 0, 6, 13, 26, 39, 52 weeks ] [ Designated as safety issue: No ]
  • Experienced forearm pain and disability, The Patient-Rated Tennis Elbow Evaluation (PRTEE) [ Time Frame: 0, 6, 13, 26, 39, 52 weeks ] [ Designated as safety issue: No ]
  • General improvement, 7-point Likert scale [ Time Frame: 0, 6, 13, 26, 39, 52 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: March 2009
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Active strength training and stretching 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: Botulinum toxin type A injections 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

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.

  Eligibility

Ages Eligible for Study:   20 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00930709

Locations
Finland
Department of Physical medicine and Rehabilitation, Seinäjoki Central Hospital
Seinäjoki, Finland, 60220
Sponsors and Collaborators
Seinajoki Central Hospital
Investigators
Principal Investigator: Aki Vainionpää, M.D., Ph.D. Department of Physical Medicine and Rehabilitation, Seinäjoki Central Hospital
  More Information

Additional Information:
No publications provided

Responsible Party: Aki Vainionpaa, Specialist in Physical Medicine and Rehabilitation, Seinajoki Central Hospital
ClinicalTrials.gov Identifier: NCT00930709     History of Changes
Other Study ID Numbers: EVO1122, EudraCT 2009-009837-14
Study First Received: June 29, 2009
Last Updated: November 25, 2013
Health Authority: Finland: Finnish Medicines Agency

Keywords provided by Seinajoki Central Hospital:
Botulinum Toxin Type A
Exercise
Randomized Controlled Trial
Muscle Stretching Exercises
Strength Training
Treatment Outcome

Additional relevant MeSH terms:
Tennis Elbow
Musculoskeletal Diseases
Arm Injuries
Wounds and Injuries
Botulinum Toxins
Botulinum Toxins, Type A
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 01, 2014