Epicondylitis, Lateral HumeralBooSTNCT00930709
Botulinum Toxin Versus Active Strength Training in the Treatment of Lateral Epicondylitis
A study testing Botulinum toxin type A (Botox®, Allergan) and Active strength training and stretching in people with Epicondylitis, Lateral Humeral and Tennis Elbow, run by Seinajoki Central Hospital at 1 site in Finland.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Epicondylitis, Lateral Humeral, Tennis Elbow
- What is being tested?
- Botulinum toxin type A (Botox®, Allergan) and Active strength training and stretching
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 103 participants
- Where
- 1 siteFinland
- Study dates
- Mar 2009to Dec 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Finland1 site
Department of Physical medicine and Rehabilitation, Seinäjoki Central Hospital
Seinäjoki, 60220
About this study
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.
Read the 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.
- Conditions
- Epicondylitis, Lateral Humeral, Tennis Elbow
- Being tested
- Botulinum toxin type A (Botox®, Allergan), Active strength training and stretching
- Keywords
- Botulinum Toxin Type A, Exercise, Randomized Controlled Trial, Muscle Stretching Exercises, Strength Training, Treatment Outcome
- Medical subject headings
- Tennis Elbow, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Botulinum toxin type A (Botox®, Allergan)Drug
Also called Botox®, Allergan, NDC 0023-1145-01
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.
Active strength training and stretchingBehavioural
Also called Eccentric strength training
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.
| Study group | Role | What they receive |
|---|---|---|
| Active strength training and stretching | Active comparator | Active strength training and stretching Receives: Behavioral: Active strength training and stretching |
| Botulinum toxin type A injections | Active comparator | Botulinum toxin type A injections Receives: Drug: Botulinum toxin type A (Botox®, Allergan) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain, 100 mm visual analogue scale, change from baseline
Measured: 0, 6, 13, 26, 39, 52 weeks
Grip strength (pain free and maximal), hydraulic hand dynamometer, change from baseline
Measured: 0, 6, 13, 26, 39, 52 weeks
Secondary outcomes (7)
Experienced disability, 100 mm visual analogue scale, change from baseline
Measured: 0, 6, 13, 26, 39, 52 weeks
Isometric wrist extension and flexion strength, digital hanging scale with rigid bench frame, change from baseline
Measured: 0, 6, 13, 26, 39, 52 weeks
Treatment adverse effects
Measured: 0, 6, 13, 26, 39, 52 weeks
Economic evaluation of interventions, direct and indirect costs
Measured: 0, 6, 13, 26, 39, 52 weeks
Days in sick leave
Measured: 0, 6, 13, 26, 39, 52 weeks
Experienced forearm pain and disability, The Patient-Rated Tennis Elbow Evaluation (PRTEE)
Measured: 0, 6, 13, 26, 39, 52 weeks
General improvement, 7-point Likert scale
Measured: 0, 6, 13, 26, 39, 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2009 (estimated)
- Study startMar 2009
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Epicondylitis, Lateral HumeralStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seinajoki Central Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aki Vainionpaa, Seinajoki Central Hospital
- Investigators
- Aki Vainionpää, M.D., Ph.D., Principal investigator, Department of Physical Medicine and Rehabilitation, Seinäjoki Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00930709
- Sponsor's protocol ID
- EVO1122
- Other IDs
- 2009-009837-14, 2009
- Acronym
- BooST
- Status last verified
- Dec 2014
- First submitted
- 29 Jun 2009
- Last updated
- 31 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Botulinum Toxin Versus Active Strength Training in Treatment of the Lateral Epicondylitis - A Single-Blinded, Randomized, Controlled Trial
- ClinicalTrials.gov ID
- NCT00930709
- Acronym / sponsor ID
- BooST / EVO1122
- Conditions
- Epicondylitis, Lateral Humeral, Tennis Elbow
- Keywords
- Botulinum Toxin Type A, Exercise, Randomized Controlled Trial, Muscle Stretching Exercises, Strength Training, Treatment Outcome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- Seinajoki Central HospitalUniversity, hospital or other
- Study start
- Mar 2009
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 30 Jun 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active strength training and stretching | Active comparator | Behavioral: Active strength training and stretchingActive strength training and stretching |
| Botulinum toxin type A injections | Active comparator | Drug: Botulinum toxin type A (Botox®, Allergan)Botulinum toxin type A injections |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Botulinum toxin type A (Botox®, Allergan)Also: Botox®, Allergan, NDC 0023-1145-01Two injections of 10-60 units of botulinum toxin type A. Injections are administered with ENMG assisted technique at the baseline and after 13 weeks. | Drug | Botulinum toxin type A injections |
| Active strength training and stretchingAlso: Eccentric strength trainingTraining 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. | Behavioural | Active strength training and stretching |
Primary outcome
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
7 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2014.
- Seinäjoki Central Hospital homepageLink provided by the sponsor.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aki Vainionpää, M.D., Ph.D. principal investigator
Department of Physical Medicine and Rehabilitation, Seinäjoki Central Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Botulinum toxin type A (Botox®, Allergan) and Active strength training and stretching in people with Epicondylitis, Lateral Humeral and Tennis Elbow, run by Seinajoki Central Hospital at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain, 100 mm visual analogue scale, change from baseline (time frame: 0, 6, 13, 26, 39, 52 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Dec 2014.