Microcurrent Therapy in the Treatment of Osteoarthritis of the Knee

Study Overview
=================
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.

Official Title
-----------------
Microcurrent Therapy in the Treatment of Osteoarthritis of the Knee: a Randomized, Controlled Pilot Study

Conditions
-----------------
Osteoarthritis,Knee

Intervention / Treatment
-----------------
* Device: Microcurrent therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
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)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Microcurrent therapy, type A<br>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<br>* 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.<br>|
| Active Comparator: Microcurrent therapy, type B<br>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<br>* 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.<br>|
| Sham Comparator: Sham Microcurrent therapy<br>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<br>* 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.<br>|
| No Intervention: No Intervention<br>No Intervention. Previous treatments will be continued. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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) | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
knee, osteoarthritis, microcurrent, electrotherapy