Influence of Microcurrent Parameters on Effectiveness in Treatment of Chronic Tennis Elbow

This study has been completed.
Sponsor:
Information provided by:
University of Hertfordshire
ClinicalTrials.gov Identifier:
NCT00905736
First received: May 20, 2009
Last updated: June 18, 2010
Last verified: August 2009
  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 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.


Condition Intervention Phase
Tennis Elbow
Procedure: Microcurrent treatment (controlled current)
Procedure: Micocurrent treatment (controlled voltage)
Phase 2
Phase 3

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

Resource links provided by NLM:


Further study details as provided by University of Hertfordshire:

Primary Outcome Measures:
  • Tissue healing as indicated by sonography [ Time Frame: baseline, 3 weeks, 6 weeks, 4 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Patient rating global change [ Time Frame: baseline, 3 weeks, 6 weeks, 4 months ] [ Designated as safety issue: No ]
  • 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 ]
  • Adverse events [ Time Frame: 3 weeks, 6 weeks, 4 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 24
Study Start Date: April 2009
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: current controlled
a current controlled microcurent device providing a primarily monophasic waveform of typical amplitude 40 microamps
Procedure: Microcurrent treatment (controlled current)
primarily monophasic waveform of average amplitude 40 microamps, 1 hr daily for 3 weeks
Experimental: voltage controlled
constant voltage amplitude delivering high frequency AC waveform
Procedure: Micocurrent treatment (controlled voltage)
Microcurrent delivered for 6 hours daily for 3 weeks

  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
  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: NCT00905736

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

Additional Information:
No publications provided

Responsible Party: Leon Poltawski, University of Hertfordshire
ClinicalTrials.gov Identifier: NCT00905736     History of Changes
Other Study ID Numbers: HEPEC/03/09/74
Study First Received: May 20, 2009
Last Updated: June 18, 2010
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by University of Hertfordshire:
tendon
healing
microcurrent
chronic tennis elbow

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

ClinicalTrials.gov processed this record on September 22, 2014