A Crossover Designed Study to Evaluate Effects of Microcurrent Therapy on Knee Osteoarthritis

Study Overview
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Brief Summary
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This crossover designed study evaluates the effects of microcurrent therapy on knee osteoarthritis. Ín a previous study patients were randomized into four different groups. Group 1 and 2 both received microcurrent therapy, but with different freqency and intensity parameters. Group 3 received treatment with the microcurrent treatment apparatus without current (sham). group 4 was a control group. In the following, present study the controll group as well as the sham group will receive the microcurrent therapy (verum).

Detailed Description
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The objective of the previous randomized, controlled pilot study was to evaluate the effect of microcurrent therapy on pain and physical function in patients with osteoarthritis of the knee. The secondary objective was to compare the effects of different currents. (group 1 - 4) After receiving 10 sessions of microcurrent therapy the statistical calculation showed a slightly significant difference in the verum-group A (Parameters Channel A: Channel B, Frequency ...) After a wash-out-phase we are now trying to evaluate and possibly confirm the positive effect of the previous trial. Therefore the control - and sham group from the previous study will now receive microcurrent therapy of apparatus A. The whole procedure (Number of session, duration of the treatments, main outcome measurements, secondary outcome measurements) of the following study is identical with the previous pilot study. Assessments four the group will be at the first day of treatment (T1) and at the end of Treatment (T2).

Official Title
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A Crossover Designed Study to Evaluate Effects of Microcurrent Therapy on Knee Osteoarthritis

Conditions
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Osteoarthritis, Knee

Intervention / Treatment
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* Device: Microcurrent therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: osteoarthritis of the knee pain intensity > 3 on the numerical rating scale (0-10) Exclusion Criteria: knee arthroplasty gravity dermal Irritation at the skin of the knee carcinoma known osteoarthritis grade 4 (Kellgren and Lawrence score)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Crossover
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: First group<br>control group fisrt and after washing out Microcurrent therapy: Channel A: 100µA; 200 Hz Duration of each treatment session: 30 minutes Number of sessions: 10 | Device: Microcurrent therapy<br>* The microcurrent therapy will be applied with electrodes that are fixed around the knee. The two electrodes of channel A will be placed at the inner and outer side of the knee that is most affected by pain. The two electrodes of channel B will be placed above and below the patella. An apparatus with CE certificate will be used.<br>|
| Active Comparator: Second group<br>Microcurrent therapy: Channel A: 100µA; 200 Hz Duration of each treatment session: 30 minutes Number of sessions: 10 after washing out control group | Device: Microcurrent therapy<br>* The microcurrent therapy will be applied with electrodes that are fixed around the knee. The two electrodes of channel A will be placed at the inner and outer side of the knee that is most affected by pain. The two electrodes of channel B will be placed above and below the patella. An apparatus with CE certificate will be used.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Numerical Rating scale (NRS) for pain (0-10) | numerical Rating scale | Change of NRS: Before treatment vs. end of treatment (in average 21 days later) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Knee injury and Osteoarthritis Outcome Score | Knee specific Instrument measuring pan, function and Quality of life. | Change of scores: Before treatment vs. end of treatment (in average 21 days later | 
| Short-Form 36 | Generic HRQOL measure | Change of scores: Before treatment vs. end of treatment (in average 21 days later) | 
| Satisfaction with Treatment (Questionnaire) | Self-administered questionnaire that was developed for this study | Evaluation at the end of treatment (in average 21 days after Start of treatment) | 
| Range of Motion knee joint | Clinical test with goniometer | Change: Before treatment vs. end of treatment (in average 21 days later) | 
| Get-up-and-Go-Test (GUG) | clinical test that measures mobility | Change: Before treatment vs. end of treatment (in average 21 days later) | 
| 6-minute walking test | Clinical test that measures the Walking ability | Change: Before treatment vs. end of treatment (in average 21 days later) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Osteoarthritis, microcurrent, knee, electrotherapy