Tennis ElbowPhase 2/3NCT00905736
Influence of Microcurrent Parameters on Effectiveness in Treatment of Chronic Tennis Elbow
A Phase 2/3 study of 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
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Apr 2009to 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University of Hertfordshire
Hatfield, Hertfordshire, AL10 9AB
About this study
Official title: Influence of Microcurrent Parameters on Effectiveness of 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 have investigated 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 is comparing the effects of two different forms of microcurrent treatment.
- Conditions
- Tennis Elbow
- Being tested
- Microcurrent treatment (controlled current), Micocurrent treatment (controlled voltage)
- Keywords
- tendon, healing, microcurrent, chronic tennis elbow
- 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 treatment (controlled current)Procedure or surgery
primarily monophasic waveform of average amplitude 40 microamps, 1 hr daily for 3 weeks
Micocurrent treatment (controlled voltage)Procedure or surgery
Microcurrent delivered for 6 hours daily for 3 weeks
| Study group | Role | What they receive |
|---|---|---|
| current controlled | Experimental | a current controlled microcurent device providing a primarily monophasic waveform of typical amplitude 40 microamps Receives: Procedure: Microcurrent treatment (controlled current) |
| voltage controlled | Experimental | constant voltage amplitude delivering high frequency AC waveform Receives: Procedure: Micocurrent treatment (controlled voltage) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tissue healing as indicated by sonography
Measured: baseline, 3 weeks, 6 weeks, 4 months
Secondary outcomes (4)
Patient rating global change
Measured: baseline, 3 weeks, 6 weeks, 4 months
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
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 posted21 May 2009 (estimated)
- Study startApr 2009
- 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
- Non-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
- NCT00905736
- Sponsor's protocol ID
- HEPEC/03/09/74
- Status last verified
- Aug 2009
- First submitted
- 20 May 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
- Influence of Microcurrent Parameters on Effectiveness of Treatment of Chronic Tennis Elbow - a Preliminary Trial
- ClinicalTrials.gov ID
- NCT00905736
- Acronym / sponsor ID
- HEPEC/03/09/74
- Conditions
- Tennis Elbow
- Keywords
- tendon, healing, microcurrent, chronic tennis elbow
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- University of HertfordshireUniversity, hospital or other
- Study start
- Apr 2009
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 21 May 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 have investigated 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 is comparing the effects of two different forms of microcurrent treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| current controlled | Experimental | Procedure: Microcurrent treatment (controlled current)a current controlled microcurent device providing a primarily monophasic waveform of typical amplitude 40 microamps |
| voltage controlled | Experimental | Procedure: Micocurrent treatment (controlled voltage)constant voltage amplitude delivering high frequency AC waveform |
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 (4 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
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 treatment (controlled current)primarily monophasic waveform of average amplitude 40 microamps, 1 hr daily for 3 weeks | Procedure or surgery | current controlled |
| Micocurrent treatment (controlled voltage)Microcurrent delivered for 6 hours daily for 3 weeks | Procedure or surgery | voltage controlled |
Primary outcome
Tissue healing as indicated by sonography
Time frame: baseline, 3 weeks, 6 weeks, 4 months
4 secondary outcomes
Patient rating global change
Time frame: baseline, 3 weeks, 6 weeks, 4 months
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
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.
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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.
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 of 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 4 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?
Tissue healing as indicated by sonography (time frame: baseline, 3 weeks, 6 weeks, 4 months). 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.