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).
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).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
13
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.
Ludwig Maximilian University, University Hosipital, Department of Orthopedics, Physical Medicine and Rehabilitation
Munich, Bavaria, Germany
Numerical Rating scale (NRS) for pain (0-10)
numerical Rating scale
Time frame: Change of NRS: Before treatment vs. end of treatment (in average 21 days later)
Knee injury and Osteoarthritis Outcome Score
Knee specific Instrument measuring pan, function and Quality of life.
Time frame: Change of scores: Before treatment vs. end of treatment (in average 21 days later
Short-Form 36
Generic HRQOL measure
Time frame: 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
Time frame: Evaluation at the end of treatment (in average 21 days after Start of treatment)
Range of Motion knee joint
Clinical test with goniometer
Time frame: Change: Before treatment vs. end of treatment (in average 21 days later)
Get-up-and-Go-Test (GUG)
clinical test that measures mobility
Time frame: Change: Before treatment vs. end of treatment (in average 21 days later)
6-minute walking test
Clinical test that measures the Walking ability
Time frame: Change: Before treatment vs. end of treatment (in average 21 days later)
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