Tennis ElbowPhase 2/3NCT00817232
Effectiveness of Microcurrent for Treatment of Tennis Elbow
A Phase 2/3 study testing Microcurrent (Elexoma Medic) in people with Tennis Elbow, run by University of Hertfordshire at 1 site in United Kingdom.
Trial summary
Tennis elbow is a relatively common musculoskeletal disorder that can cause significant pain and disability. Treatment of the disorder is not always successful, and it often recurs or becomes chronic. More effective management options are required. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tennis Elbow
- What is being tested?
- Microcurrent (Elexoma Medic)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Dec 2008to Dec 2009
- Phase
- Phase 2/3
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- symptoms of tennis elbow for at least 3 months
- clinical diagnosis of tennis elbow
Who cannot join
- significant symptom improvement in previous month
- receipt of any active treatment for the condition in the previous month
- currently under the care of another health professional for tennis elbow
- current cervical radiculopathy
- other pathology affecting distal upper limb
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University of Hertfordshire
Hatfield, Hertfordshire, AL10 9AB
About this study
Official title: Effectiveness of Microcurrent in the Treatment of Chronic Tennis Elbow - a Preliminary Trial
Tennis elbow is a relatively common musculoskeletal disorder that can cause significant pain and disability. Treatment of the disorder is not always successful, and it often recurs or becomes chronic. More effective management options are required. There is evidence that electric microcurrent can promote tissue healing and symptom resolution in various chronic hard and soft tissue disorders, but few human studies investigating its use with chronic tendon problems. It is an easily applied therapy with very few reports of side effects. It can be applied at home using a portable unit and, if it is clinically effective, may also prove more cost effective than other therapies.
A clinical trial is planned to evaluate the therapy but, in the absence of relevant published evidence, a preliminary study is required to look for a treatment effect and inform a power calculation for sample size, The study will also allow some investigation of dose-dependence, which is a key issue in many forms of electrotherapy. Finally it will enable evaluation of elements of the full trial protocol so that any weaknesses can be addressed before it begins.
- Conditions
- Tennis Elbow
- Being tested
- Microcurrent (Elexoma Medic)
- Keywords
- tennis elbow, microcurrent, tissue healing
- Medical subject headings
- Tennis Elbow
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Microcurrent (Elexoma Medic)Device
Also called Elexoma Medic
monophasic frequency modulated square wave current applied for 99 minutes daily for 21 days
| Study group | Role | What they receive |
|---|---|---|
| Treatment 1 | Experimental | 50 microamp amplitude Receives: Device: Microcurrent (Elexoma Medic) |
| Treatment 2 | Experimental | 500 microamp amplitude Receives: Device: Microcurrent (Elexoma Medic) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tendon pathology as indicated by sonography
Measured: baseline, 3 weeks, 6 weeks, 4 months
Patient-Rated Global Change Score
Measured: 3 weeks, 6 weeks, 4 months
Secondary outcomes (4)
Pain Free Grip Strength
Measured: baseline, 3 weeks, 6 weeks, 4 months
Patient-rated Tennis Elbow Questionnaire
Measured: baseline, 3 weeks, 6 weeks, 4 months
Patient-Specific Functional Scale
Measured: baseline, 3 weeks, 6 weeks, 4 months
Adverse events
Measured: 3 weeks, 6 weeks, 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2009 (estimated)
- Study startDec 2008
- Primary completionDec 2009
- Study completionDec 2009
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.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Hertfordshire
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00817232
- Sponsor's protocol ID
- HEPEC/10/08/05
- Status last verified
- Aug 2009
- First submitted
- 5 Jan 2009
- Last updated
- 22 Jun 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Microcurrent in the Treatment of Chronic Tennis Elbow - a Preliminary Trial
- ClinicalTrials.gov ID
- NCT00817232
- Acronym / sponsor ID
- HEPEC/10/08/05
- Conditions
- Tennis Elbow
- Keywords
- tennis elbow, microcurrent, tissue healing
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- University of HertfordshireUniversity, hospital or other
- Study start
- Dec 2008
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 6 Jan 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.
Tennis elbow is a relatively common musculoskeletal disorder that can cause significant pain and disability. Treatment of the disorder is not always successful, and it often recurs or becomes chronic. More effective management options are required. There is evidence that electric microcurrent can promote tissue healing and symptom resolution in various chronic hard and soft tissue disorders, but few human studies investigating its use with chronic tendon problems. It is an easily applied therapy with very few reports of side effects. It can be applied at home using a portable unit and, if it is clinically effective, may also prove more cost effective than other therapies.
A clinical trial is planned to evaluate the therapy but, in the absence of relevant published evidence, a preliminary study is required to look for a treatment effect and inform a power calculation for sample size, The study will also allow some investigation of dose-dependence, which is a key issue in many forms of electrotherapy. Finally it will enable evaluation of elements of the full trial protocol so that any weaknesses can be addressed before it begins.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment 1 | Experimental | Device: Microcurrent (Elexoma Medic)50 microamp amplitude |
| Treatment 2 | Experimental | Device: Microcurrent (Elexoma Medic)500 microamp amplitude |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- symptoms of tennis elbow for at least 3 months
- clinical diagnosis of tennis elbow
Key exclusion criteria (5 listed)
- significant symptom improvement in previous month
- receipt of any active treatment for the condition in the previous month
- currently under the care of another health professional for tennis elbow
- current cervical radiculopathy
- other pathology affecting distal upper limb
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 |
|---|---|---|
| Microcurrent (Elexoma Medic)Also: Elexoma Medicmonophasic frequency modulated square wave current applied for 99 minutes daily for 21 days | Device | Treatment 1, Treatment 2 |
Primary outcome
Tendon pathology as indicated by sonography
Time frame: baseline, 3 weeks, 6 weeks, 4 months
Patient-Rated Global Change Score
Time frame: 3 weeks, 6 weeks, 4 months
4 secondary outcomes
Pain Free Grip Strength
Time frame: baseline, 3 weeks, 6 weeks, 4 months
Patient-rated Tennis Elbow Questionnaire
Time frame: baseline, 3 weeks, 6 weeks, 4 months
Patient-Specific Functional Scale
Time frame: baseline, 3 weeks, 6 weeks, 4 months
Adverse events
Time frame: 3 weeks, 6 weeks, 4 months
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 22 Jun 2010.
- application of electrotherapyLink provided by the sponsor.
Related trials for Tennis Elbow
Not yet recruitingObservational study
Investigation of Obsessive-Compulsive Disorder in Patients With Elbow Epicondylitis
Lateral Epicondylitis, Medial Epicondylitis
Recruiting
A Comparison of the Effects of Combining ESWT With Blood Flow Restriction Therapy in Patients Diagnosed With Lateral Epicondylitis
Lateral Epicondylitis
Recruiting
Effect of Ultrasound-Guided Posterior Cutaneous Nerve of the Forearm Epicondylar Branch Block on Pain and Function in Lateral Epicondylitis (PCNF-BrEpi)
Lateral Epicondylitis
Not yet recruiting
Comparing Surgical and Nonsurgical Outcomes of Tennis Elbow
Lateral Epicondylitis
Not yet recruiting
Comparative Effectiveness of Ultrasound-Guided Tenoxicam and Corticosteroid Injections for Lateral Epicondylitis
Lateral Epicondylitis
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Microcurrent (Elexoma Medic) in people with Tennis Elbow, run by University of Hertfordshire at 1 site in United Kingdom.
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 5 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 22 Jun 2010. 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 United Kingdom. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Tendon pathology as indicated by sonography (time frame: baseline, 3 weeks, 6 weeks, 4 months). 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 22 Jun 2010.