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

Tennis Elbow Clinical Trial

Official title:

Influence of Microcurrent Parameters on Effectiveness of Treatment of Chronic Tennis Elbow - a Preliminary Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00905736
• Other study ID #: HEPEC/03/09/74
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: May 20, 2009
• Last updated: June 18, 2010
• Start date: April 2009
• Est. completion date: December 2009

Study information

• Verified date: August 2009
• Source: University of Hertfordshire
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Tennis Elbow

Intervention

Procedure:
• Microcurrent treatment (controlled current)
primarily monophasic waveform of average amplitude 40 microamps, 1 hr daily for 3 weeks
• Micocurrent treatment (controlled voltage)
Microcurrent delivered for 6 hours daily for 3 weeks

Locations

Country	Name	City	State
United Kingdom	University of Hertfordshire	Hatfield	Hertfordshire

Sponsors (1)

Lead Sponsor	Collaborator
University of Hertfordshire

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tissue healing as indicated by sonography		baseline, 3 weeks, 6 weeks, 4 months	No
Secondary	Patient rating global change		baseline, 3 weeks, 6 weeks, 4 months	No
Secondary	Pain free grip strength		baseline, 3 weeks, 6 weeks, 4 months	No
Secondary	Patient rated tennis elbow questionnaire		baseline, 3 weeks, 6 weeks, 4 months	No
Secondary	Adverse events		3 weeks, 6 weeks, 4 months	Yes

External Links

•   application of electrotherapy