Lateral EpicondylitisEpi-XNCT00888225
Tennis Elbow Trial
A study testing Eccentric exercise and Concentric exercise in people with Lateral Epicondylitis, run by Uppsala University at 2 sites in Sweden.
Trial summary
Epi-X is a multicentered randomized controlled clinical trial of chronic lateral epicondylitis with parallel group design and two phases. In the first phase physical exercise treatment is given in the intervention group and expectance in the reference group. In phase 2 eccentric exercise versus concentric is tested. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Lateral Epicondylitis
- What is being tested?
- Eccentric exercise and Concentric exercise
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 205 participants
- Where
- 2 sitesSweden
- Study dates
- Oct 2003to Dec 2008
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Verified tennis elbow for more than three months
- Age 20-75 years
- Informed consent
Who cannot join
- Inability to understand or follow instructions
- Inability to read or fill in questionnaires
- Inability to participate at measurement sessions
- Supinator syndrome
- Compartment syndrome of anconeus muscle
- Rhizopathy of arm
- Inflammatory joint or soft tissue disease including fibromyalgia
- Previous surgery because of tennis elbow
Trial locations and contacts
2 sites in 1 country.
Sweden2 sites
Linköping University
Linköping, SE-58183
Uppsala University, Dept of Public Health and Caring Sciences, Family Medicine and Clinical Epidemiology Section
Uppsala, SE-75185
About this study
Official title: Chronic Lateral Epicondylitis. A Randomized Controlled Clinical Trial of Two Physical Training Concepts With Special Reference to Etiology and Treatment Effect
Epi-X is a multicentered randomized controlled clinical trial of chronic lateral epicondylitis with parallel group design and two phases. In the first phase physical exercise treatment is given in the intervention group and expectance in the reference group. In phase 2 eccentric exercise versus concentric is tested.
Read the detailed description
Chronic lateral epicondylitis is defined as the presence of a "tennis elbow" for more than 3 months. It is a common condition in the general population and often results in long-term sick-leave. The etiology is unknown. A large number of treatments have been tried but none is generally accepted. However, in Achilles tendinitis a new treatment has been shown effective. It consists of eccentric exercise, i.e. work during stretching rather than shortening of the muscle (concentric exercise). The latter is currently the most common treatment method.
This project is a randomised controlled clinical trial of eccentric versus concentric exercise in 205 patients with chronic lateral epicondylitis. Pain and muscle strength were recorded at start of treatment and after 1,2,3,6 and 12 months. Activities of daily life (ADL) and well-being were recorded at start of treatment and after 3, 6 and 12 months. In addition, blood specimens for a number of neural peptides have been sampled. Moreover, the involvement of the peripheral nervous system in the elbow area has been examined in a subsample of patients. A biopsy from 20 patients per treatment group and from 20 healthy subjects, and a positron emission tomography (PET) scan of 23 patients were performed to allow qualitative and quantitative examination of neural fibres, peptides and receptors. The health economy of the two treatments will be investigated using data from this project and from available registers.
- Conditions
- Lateral Epicondylitis
- Being tested
- Eccentric exercise, Concentric exercise
- Keywords
- Tennis elbow, Epicondylitis, Pain, Muscle strength, Quality of life, RCT, Tendinitis, Chronic tennis elbow
- Medical subject headings
- Tennis Elbow, Pain, Tendinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eccentric exerciseProcedure or surgery
Eccentric exercise treatment performed at home with three sets of 15 repetitions daily
Concentric exerciseProcedure or surgery
Concentric exercise treatment at home with three sets of 15 repetitions daily
| Study group | Role | What they receive |
|---|---|---|
| Eccentric exercise | Experimental | Group exposed to eccentric exercise treatment Receives: Procedure: Eccentric exercise |
| Concentric exercise | Active comparator | Group exposed to concentric exercise treatment Receives: Procedure: Concentric exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain during dynamic and static muscle load
Measured: Month 0, 1, 2, 3, 6, 12
Secondary outcomes (1)
Muscle strength and function
Measured: Month 0, 1, 2, 3, 6, 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2009 (estimated)
- Study startOct 2003
- Primary completionJan 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Lateral EpicondylitisStudies 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
- Participant
- Enrolment
- 205 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uppsala University
- Sponsor type
- University, hospital or other
- Collaborators
- The Swedish Research Council, Amersham Foundation, Uppsala County Council, Sweden
- Investigators
- Kurt Svärdsudd, MD, PhD, Principal investigator, Uppsala University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00888225
- Sponsor's protocol ID
- VR K2005
- Acronym
- Epi-X
- Status last verified
- Apr 2009
- First submitted
- 24 Apr 2009
- Last updated
- 27 Apr 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Peterson M, Svardsudd K, Appel L, Engler H, Aarnio M, Gordh T, Langstrom B, Sorensen J. PET-scan shows peripherally increased neurokinin 1 receptor availability in chronic tennis elbow: visualizing neurogenic inflammation? PLoS One. 2013 Oct 14;8(10):e75859. doi: 10.1371/journal.pone.0075859. eCollection 2013.
PubMed 24155873Peterson M, Butler S, Eriksson M, Svardsudd K. A randomized controlled trial of exercise versus wait-list in chronic tennis elbow (lateral epicondylosis). Ups J Med Sci. 2011 Nov;116(4):269-79. doi: 10.3109/03009734.2011.600476.
PubMed 22066975
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chronic Lateral Epicondylitis. A Randomized Controlled Clinical Trial of Two Physical Training Concepts With Special Reference to Etiology and Treatment Effect
- ClinicalTrials.gov ID
- NCT00888225
- Acronym / sponsor ID
- Epi-X / VR K2005
- Conditions
- Lateral Epicondylitis
- Keywords
- Tennis elbow, Epicondylitis, Pain, Muscle strength, Quality of life, RCT, Tendinitis, Chronic tennis elbow
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 205 participants (actual)
- Lead sponsor
- Uppsala UniversityUniversity, hospital or other
- Collaborators
- The Swedish Research Council, Amersham Foundation, Uppsala County Council, Sweden
- Study start
- Oct 2003
- Primary completion
- Jan 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 27 Apr 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.
Epi-X is a multicentered randomized controlled clinical trial of chronic lateral epicondylitis with parallel group design and two phases. In the first phase physical exercise treatment is given in the intervention group and expectance in the reference group. In phase 2 eccentric exercise versus concentric is tested.
Detailed description
Chronic lateral epicondylitis is defined as the presence of a "tennis elbow" for more than 3 months. It is a common condition in the general population and often results in long-term sick-leave. The etiology is unknown. A large number of treatments have been tried but none is generally accepted. However, in Achilles tendinitis a new treatment has been shown effective. It consists of eccentric exercise, i.e. work during stretching rather than shortening of the muscle (concentric exercise). The latter is currently the most common treatment method.
This project is a randomised controlled clinical trial of eccentric versus concentric exercise in 205 patients with chronic lateral epicondylitis. Pain and muscle strength were recorded at start of treatment and after 1,2,3,6 and 12 months. Activities of daily life (ADL) and well-being were recorded at start of treatment and after 3, 6 and 12 months. In addition, blood specimens for a number of neural peptides have been sampled. Moreover, the involvement of the peripheral nervous system in the elbow area has been examined in a subsample of patients. A biopsy from 20 patients per treatment group and from 20 healthy subjects, and a positron emission tomography (PET) scan of 23 patients were performed to allow qualitative and quantitative examination of neural fibres, peptides and receptors. The health economy of the two treatments will be investigated using data from this project and from available registers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Eccentric exercise | Experimental | Procedure: Eccentric exerciseGroup exposed to eccentric exercise treatment |
| Concentric exercise | Active comparator | Procedure: Concentric exerciseGroup exposed to concentric exercise treatment |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Verified tennis elbow for more than three months
- Age 20-75 years
- Informed consent
Key exclusion criteria (8 listed)
- Inability to understand or follow instructions
- Inability to read or fill in questionnaires
- Inability to participate at measurement sessions
- Supinator syndrome
- Compartment syndrome of anconeus muscle
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 |
|---|---|---|
| Eccentric exerciseEccentric exercise treatment performed at home with three sets of 15 repetitions daily | Procedure or surgery | Eccentric exercise |
| Concentric exerciseConcentric exercise treatment at home with three sets of 15 repetitions daily | Procedure or surgery | Concentric exercise |
Primary outcome
Pain during dynamic and static muscle load
Time frame: Month 0, 1, 2, 3, 6, 12
1 secondary outcome
Muscle strength and function
Time frame: Month 0, 1, 2, 3, 6, 12
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 27 Apr 2009.
- Derived from this study: PubMed 24155873Peterson M, Svardsudd K, Appel L, Engler H, Aarnio M, Gordh T, Langstrom B, Sorensen J. PET-scan shows peripherally increased neurokinin 1 receptor availability in chronic tennis elbow: visualizing neurogenic inflammation? PLoS One. 2013 Oct 14;8(10):e75859. doi: 10.1371/journal.pone.0075859. eCollection 2013.
- Derived from this study: PubMed 22066975Peterson M, Butler S, Eriksson M, Svardsudd K. A randomized controlled trial of exercise versus wait-list in chronic tennis elbow (lateral epicondylosis). Ups J Med Sci. 2011 Nov;116(4):269-79. doi: 10.3109/03009734.2011.600476.
- Uppsala University, Department of Public Health and Caring Sciences, Family Medicine and Clinical Epidemiology Section, SwedenLink provided by the sponsor.
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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.
Kurt Svärdsudd, MD, PhD principal investigator
Uppsala University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Eccentric exercise and Concentric exercise in people with Lateral Epicondylitis, run by Uppsala University at 2 sites in Sweden.
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 3 inclusion and 8 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 27 Apr 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Sweden. 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 during dynamic and static muscle load (time frame: Month 0, 1, 2, 3, 6, 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00888225, which also lists 2 linked publications.
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 27 Apr 2009.