Osteoarthritis,Knee
Conditions
Keywords
osteoarthritis, microcurrent, knee, electrotherapy
Brief summary
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.
Detailed description
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.
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
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
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 Ratings 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