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Effectiveness of Microcurrent for Treatment of Tennis Elbow

This study has been completed.
Sponsor:
Information provided by:
University of Hertfordshire
ClinicalTrials.gov Identifier:
NCT00817232
First received: January 5, 2009
Last updated: June 18, 2010
Last verified: August 2009
History of Changes
  Purpose

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 Intervention Phase
Tennis Elbow
 Device: Microcurrent (Elexoma Medic)
 Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effectiveness of Microcurrent in the Treatment of Chronic Tennis Elbow - a Preliminary Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Hertfordshire:

Primary Outcome Measures:
  • Tendon pathology as indicated by sonography [ Time Frame: baseline, 3 weeks, 6 weeks, 4 months ] [ Designated as safety issue: No ]
  • Patient-Rated Global Change Score [ Time Frame: 3 weeks, 6 weeks, 4 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pain Free Grip Strength [ Time Frame: baseline, 3 weeks, 6 weeks, 4 months ] [ Designated as safety issue: No ]
  • Patient-rated Tennis Elbow Questionnaire [ Time Frame: baseline, 3 weeks, 6 weeks, 4 months ] [ Designated as safety issue: No ]
  • Patient-Specific Functional Scale [ Time Frame: baseline, 3 weeks, 6 weeks, 4 months ] [ Designated as safety issue: No ]
  • Adverse events [ Time Frame: 3 weeks, 6 weeks, 4 months ] [ Designated as safety issue: Yes ]
Estimated Enrollment: 24
Study Start Date: December 2008
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00817232

Locations
United Kingdom
University of Hertfordshire
Hatfield, Hertfordshire, United Kingdom, AL10 9AB
Sponsors and Collaborators
University of Hertfordshire
  More Information

Additional Information:
application of electrotherapy  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Leon Poltawski, University of Hertfordshire
ClinicalTrials.gov Identifier: NCT00817232     History of Changes
Other Study ID Numbers: HEPEC/10/08/05
Study First Received: January 5, 2009
Last Updated: June 18, 2010
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by University of Hertfordshire:
tennis elbow
microcurrent
tissue healing

Additional relevant MeSH terms:
Tennis Elbow
Arm Injuries
Musculoskeletal Diseases
Wounds and Injuries

ClinicalTrials.gov processed this record on February 27, 2015