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| Name | Class |
|---|---|
| Federal Ministry for Economic Affairs and Energy | OTHER |
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This study evaluates the effect of Microcurrent Therapy in the treatment of osteoarthritis of the knee. Patients will be randomized to four groups: Group 1 and 2 both will receive Microcurrent Therapy, but different currents will be used. Group 3 will receive treatment with the Microcurrent treatment apparatus, but without any current. Group 4 will be a control group without specific interventions.
The objective of this randomized, controlled pilot study is to evaluate the effect of Microcurrent therapy on pain and physical function in patients with osteoarthritis of the knee. The secondary objective is to compare the effects of different currents. Patients will be randomized to four groups: Group 1 and 2 both will receive Microcurrent Therapy, but different currents will be used. Group 3 will receive treatment with the Microcurrent treatment apparatus, but without any current. Group 4 will be a control group without specific intervention.
Group 1, 2 and 3 will receive 10 sessions of treatment in a treatment phase of four weeks. Assessments for group 1, 2, and 3 will be scheduled for screening (T0), at the first day of treatment (T1), at the end of treatment (T2) and three months after the end of treatment (T3). Group 4 will be assessed at a screening visit T0, at T1, at T2 (approximately 21 days after T1), and at T3 (three months after T2). Patients will be recruited based on the records of the clinic.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Microcurrent therapy, type A | Active Comparator | Microcurrent therapy: Channel A: 100 µA; 200 Hz; Channel B: 100 µA; 300 Hz. Duration of each treatment session: 30 minutes. Number of sessions: 10. Previous treatments will be continued. |
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| Microcurrent therapy, type B | Active Comparator | Microcurrent therapy: Channel A: 25 µA; 200 Hz; Channel B: 100 µA; 300 Hz. Duration of each treatment session: 30 minutes. Number of sessions: 10. Previous treatments will be continued. |
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| Sham Microcurrent therapy | Sham Comparator | Microcurrent therapy: Channel A: 0 µA; 0 Hz; Channel B: 0 µA; 0 Hz. Duration of each treatment session: 30 minutes. Number of sessions: 10. Previous treatments will be continued. |
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| No Intervention | No Intervention | No Intervention. Previous treatments will be continued. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Microcurrent therapy | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Numerical Ratings scale (NRS) for pain (0-10) | numerical Rating scale | Change of NRS: Before treatment vs. end of treatment (in average 21 days later) |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Martin B Weigl | Department of Orthopedics, Physical Medicine and Rehabilitation, University Hospital Munich, Ludwig Maximilians University Munich | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ludwig Maximilian University, University Hosipital, Department of Orthopedics, Physical Medicine and Rehabilitation | Munich | 81377 | Germany |
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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|
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) |