Tennis ElbowNCT00975442
Effects of Eccentric Training for Patients With Lateral Epicondylalgia
A study testing Eccentric training and Forearm band in people with Tennis Elbow and Epicondylitis, Lateral Humeral, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
The purpose of this study is to evaluate eccentric training as an intervention for lateral epicondylalgia (tennis elbow) in a clinical setting. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tennis Elbow, Epicondylitis, Lateral Humeral
- What is being tested?
- Eccentric training and Forearm band
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 1 siteSweden
- Study dates
- Feb 2005to May 2005
- 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 18 years and older
- All sexes
- Adult, Older adult
Who may be able to join
- Positive diagnostic criteria according to Haker (1991): A history of pain around the lateral epicondyle for at least one month.
- Pain at palpation of the lateral epicondyle of humerus and positive results in two of the following three pain provocation tests: Middle finger test, resisted extension of the wrist, and Vigorimeter test. Each of these tests is described in detail by Haker (1991)
Who cannot join
- Subjects with rheumatoid arthritis
- Fibromyalgia
- Previous surgery in the elbow region
- Neck dysfunction suggesting possible cervical rhizopathy
- Entrapment of n.radialis
- Patients with ongoing treatment, or previous treatment less than three months before enrolled to the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Eccentric Training for Patients With Lateral Epicondylalgia - a Randomized Controlled Trial
The purpose of this study is to evaluate eccentric training as an intervention for lateral epicondylalgia (tennis elbow) in a clinical setting.
- Conditions
- Tennis Elbow, Epicondylitis, Lateral Humeral
- Being tested
- Eccentric training, Forearm band
- Keywords
- Elbow, Tendinitis, Sports Medicine, Athletic injuries
- Medical subject headings
- Tennis Elbow, Tendinopathy, Athletic Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eccentric trainingOther
A home training program of eccentric training of the wrist extensors to be carried out daily with 3 sets of 15 repetitions. All subjects were instructed to use the forearm band (Epi Forsa 4061, Rehband, Sweden)
Forearm bandDevice
Also called Epi Forsa 4061, Rehband, Sweden
All subjects were instructed to use the forearm band during all daily activities.
Forearm bandDevice
Also called Epi Forsa 4061, Rehband, Sweden
All patients were instructed to use a forearm band during all daily activities.
| Study group | Role | What they receive |
|---|---|---|
| Eccentric training | Experimental | Not described Receives: Other: Eccentric training; Device: Forearm band |
| Forearm band | Placebo comparator | Not described Receives: Device: Forearm band |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic criteria, whether or not the patient had recovered according to the diagnostic criteria for LE, Haker (1991) at follow up examinations
Measured: 3 wk and 6 wk follow up
Secondary outcomes (1)
Measurements of pain free functional grip strength using the Martin Vigorimeter test, and maximum pain free isometric extensor strength by using Nicholas Myometer
Measured: 3 wk and 6 wk follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2009 (estimated)
- Study startFeb 2005
- Primary completionMay 2005
- Study completionMay 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tennis ElbowStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- 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
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- Rehband Sweden
- Investigators
- Johan Söderberg, P.T., Principal investigator, Department of Neurobiology, Care Sciences and Society, Division of Physiotherapy, Karolinska Institutet, Huddinge, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00975442
- Sponsor's protocol ID
- 221/00
- Status last verified
- Sep 2009
- First submitted
- 10 Sep 2009
- Last updated
- 11 Sep 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Eccentric Training for Patients With Lateral Epicondylalgia - a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT00975442
- Acronym / sponsor ID
- 221/00
- Conditions
- Tennis Elbow, Epicondylitis, Lateral Humeral
- Keywords
- Elbow, Tendinitis, Sports Medicine, Athletic injuries
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- Rehband Sweden
- Study start
- Feb 2005
- Primary completion
- May 2005 (actual)
- Study completion
- May 2005 (actual)
- First posted
- 11 Sep 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 evaluate eccentric training as an intervention for lateral epicondylalgia (tennis elbow) in a clinical setting.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Eccentric training | Experimental | Other: Eccentric training, Device: Forearm band |
| Forearm band | Placebo comparator | Device: Forearm band |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Positive diagnostic criteria according to Haker (1991): A history of pain around the lateral epicondyle for at least one month.
- Pain at palpation of the lateral epicondyle of humerus and positive results in two of the following three pain provocation tests: Middle finger test, resisted extension of the wrist, and Vigorimeter test. Each of these tests is described in detail by Haker (1991)
Key exclusion criteria (6 listed)
- Subjects with rheumatoid arthritis
- Fibromyalgia
- Previous surgery in the elbow region
- Neck dysfunction suggesting possible cervical rhizopathy
- Entrapment of n.radialis
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 trainingA home training program of eccentric training of the wrist extensors to be carried out daily with 3 sets of 15 repetitions. All subjects were instructed to use the forearm band (Epi Forsa 4061, Rehband, Sweden) | Other | Eccentric training |
| Forearm bandAlso: Epi Forsa 4061, Rehband, SwedenAll subjects were instructed to use the forearm band during all daily activities. | Device | Forearm band |
| Forearm bandAlso: Epi Forsa 4061, Rehband, SwedenAll patients were instructed to use a forearm band during all daily activities. | Device | Eccentric training |
Primary outcome
Diagnostic criteria, whether or not the patient had recovered according to the diagnostic criteria for LE, Haker (1991) at follow up examinations
Time frame: 3 wk and 6 wk follow up
1 secondary outcome
Measurements of pain free functional grip strength using the Martin Vigorimeter test, and maximum pain free isometric extensor strength by using Nicholas Myometer
Time frame: 3 wk and 6 wk follow-up
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 11 Sep 2009.
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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.
Johan Söderberg, P.T. principal investigator
Department of Neurobiology, Care Sciences and Society, Division of Physiotherapy, Karolinska Institutet, Huddinge, Sweden
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Eccentric training and Forearm band in people with Tennis Elbow and Epicondylitis, Lateral Humeral, run by Karolinska Institutet at 1 site 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 2 inclusion and 6 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 11 Sep 2009. 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 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. Some participants in this study may receive a placebo. 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?
Diagnostic criteria, whether or not the patient had recovered according to the diagnostic criteria for LE, Haker (1991) at follow up examinations (time frame: 3 wk and 6 wk follow up). 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 11 Sep 2009.