Osteoarthritis, Knee
Conditions
Keywords
Osteoarthritis, microcurrent, knee, electrotherapy
Brief summary
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
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).
Interventions
DEVICEMicrocurrent therapy
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.
Sponsors
Federal Ministry for Economic Affairs and Energy
Ludwig-Maximilians - University of Munich
Study design
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Crossover
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Numerical Rating scale (NRS) for pain (0-10) | Change of NRS: Before treatment vs. end of treatment (in average 21 days later) | numerical Rating scale |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Short-Form 36 | Change of scores: Before treatment vs. end of treatment (in average 21 days later) | Generic HRQOL measure |
| Satisfaction with Treatment (Questionnaire) | Evaluation at the end of treatment (in average 21 days after Start of treatment) | Self-administered questionnaire that was developed for this study |
| Knee injury and Osteoarthritis Outcome Score | Change of scores: Before treatment vs. end of treatment (in average 21 days later | Knee specific Instrument measuring pan, function and Quality of life. |
| Get-up-and-Go-Test (GUG) | Change: Before treatment vs. end of treatment (in average 21 days later) | clinical test that measures mobility |
| 6-minute walking test | Change: Before treatment vs. end of treatment (in average 21 days later) | Clinical test that measures the Walking ability |
| Range of Motion knee joint | Change: Before treatment vs. end of treatment (in average 21 days later) | Clinical test with goniometer |
Countries
Germany
Outcome results
None listed