Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Effectiveness of Microcurrent for Treatment of Tennis Elbow

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00817232
Recruitment Status : Completed
First Posted : January 6, 2009
Last Update Posted : June 22, 2010
Sponsor:
Information provided by:
University of Hertfordshire

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief 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. 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.


Condition or disease Intervention/treatment Phase
Tennis Elbow Device: Microcurrent (Elexoma Medic) Phase 2 Phase 3

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effectiveness of Microcurrent in the Treatment of Chronic Tennis Elbow - a Preliminary Trial
Study Start Date : December 2008
Actual Primary Completion Date : December 2009
Actual Study Completion Date : December 2009

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Treatment 1
50 microamp amplitude
 Device: Microcurrent (Elexoma Medic)
monophasic frequency modulated square wave current applied for 99 minutes daily for 21 days
Other Name: Elexoma Medic
Experimental: Treatment 2
500 microamp amplitude
 Device: Microcurrent (Elexoma Medic)
monophasic frequency modulated square wave current applied for 99 minutes daily for 21 days
Other Name: Elexoma Medic


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Tendon pathology as indicated by sonography [ Time Frame: baseline, 3 weeks, 6 weeks, 4 months ]
  2. Patient-Rated Global Change Score [ Time Frame: 3 weeks, 6 weeks, 4 months ]

Secondary Outcome Measures :
  1. Pain Free Grip Strength [ Time Frame: baseline, 3 weeks, 6 weeks, 4 months ]
  2. Patient-rated Tennis Elbow Questionnaire [ Time Frame: baseline, 3 weeks, 6 weeks, 4 months ]
  3. Patient-Specific Functional Scale [ Time Frame: baseline, 3 weeks, 6 weeks, 4 months ]
  4. Adverse events [ Time Frame: 3 weeks, 6 weeks, 4 months ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • symptoms of tennis elbow for at least 3 months
  • clinical diagnosis of tennis elbow

Exclusion Criteria:

  • 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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00817232


Locations
Layout table for location information
United Kingdom
University of Hertfordshire
Hatfield, Hertfordshire, United Kingdom, AL10 9AB
Sponsors and Collaborators
University of Hertfordshire
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Additional Information:

Layout table for additonal information
Responsible Party: Leon Poltawski, University of Hertfordshire
ClinicalTrials.gov Identifier: NCT00817232    
Other Study ID Numbers: HEPEC/10/08/05
First Posted: January 6, 2009    Key Record Dates
Last Update Posted: June 22, 2010
Last Verified: August 2009
Keywords provided by University of Hertfordshire:
tennis elbow
microcurrent
tissue healing
Additional relevant MeSH terms:
Layout table for MeSH terms
Tennis Elbow
Elbow Tendinopathy
Tendinopathy
Muscular Diseases
 Musculoskeletal Diseases
Arm Injuries
Wounds and Injuries
Tendon Injuries