An interventional study of Microcurrent therapy in Osteoarthritis,Knee, sponsored by Ludwig-Maximilians - University of Munich. Completed at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-10-12.
Sponsored by Ludwig-Maximilians - University of Munich · Not applicable, Interventional, and Treatment
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.
3,391 studies on the registry are indexed under Osteoarthritis, Knee; 628 are open to participants now.
This study's enrollment of 56 is below the median of 69 across 2,808 interventional studies indexed under Osteoarthritis, Knee.
Browse Osteoarthritis, Knee studies →Ludwig-Maximilians - University of Munich is the lead sponsor of 223 studies on the registry; 29 are open to participants now.
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Exclusion Criteria:
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.
Device: Microcurrent therapy
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.
Device: Microcurrent therapy
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.
Device: Microcurrent therapy
No Intervention. Previous treatments will be continued.
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.
Numerical Ratings 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)
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Oct 2017. You cannot join it, but the record below documents what was studied.
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