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

Primary Purpose

Tennis Elbow

Status
Completed
Phase
Phase 2
Locations
United Kingdom
Study Type
Interventional
Intervention
Microcurrent treatment (controlled current)
Micocurrent treatment (controlled voltage)
Sponsored by
University of Hertfordshire
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tennis Elbow focused on measuring tendon, healing, microcurrent, chronic tennis elbow

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Hertfordshire

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

current controlled

voltage controlled

Arm Description

a current controlled microcurent device providing a primarily monophasic waveform of typical amplitude 40 microamps

constant voltage amplitude delivering high frequency AC waveform

Outcomes

Primary Outcome Measures

Tissue healing as indicated by sonography

Secondary Outcome Measures

Patient rating global change
Pain free grip strength
Patient rated tennis elbow questionnaire
Adverse events

Full Information

First Posted
May 20, 2009
Last Updated
June 18, 2010
Sponsor
University of Hertfordshire
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1. Study Identification

Unique Protocol Identification Number
NCT00905736
Brief Title
Influence of Microcurrent Parameters on Effectiveness in Treatment of Chronic Tennis Elbow
Official Title
Influence of Microcurrent Parameters on Effectiveness of Treatment of Chronic Tennis Elbow - a Preliminary Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2009
Overall Recruitment Status
Completed
Study Start Date
April 2009 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
December 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Hertfordshire

4. Oversight

Data Monitoring Committee
No

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tennis Elbow
Keywords
tendon, healing, microcurrent, chronic tennis elbow

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
current controlled
Arm Type
Experimental
Arm Description
a current controlled microcurent device providing a primarily monophasic waveform of typical amplitude 40 microamps
Arm Title
voltage controlled
Arm Type
Experimental
Arm Description
constant voltage amplitude delivering high frequency AC waveform
Intervention Type
Procedure
Intervention Name(s)
Microcurrent treatment (controlled current)
Intervention Description
primarily monophasic waveform of average amplitude 40 microamps, 1 hr daily for 3 weeks
Intervention Type
Procedure
Intervention Name(s)
Micocurrent treatment (controlled voltage)
Intervention Description
Microcurrent delivered for 6 hours daily for 3 weeks
Primary Outcome Measure Information:
Title
Tissue healing as indicated by sonography
Time Frame
baseline, 3 weeks, 6 weeks, 4 months
Secondary Outcome Measure Information:
Title
Patient rating global change
Time Frame
baseline, 3 weeks, 6 weeks, 4 months
Title
Pain free grip strength
Time Frame
baseline, 3 weeks, 6 weeks, 4 months
Title
Patient rated tennis elbow questionnaire
Time Frame
baseline, 3 weeks, 6 weeks, 4 months
Title
Adverse events
Time Frame
3 weeks, 6 weeks, 4 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
University of Hertfordshire
City
Hatfield
State/Province
Hertfordshire
ZIP/Postal Code
AL10 9AB
Country
United Kingdom

12. IPD Sharing Statement

Links:
URL
http://www.electrotherapy.org
Description
application of electrotherapy

Learn more about this trial

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

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