A Crossover Designed Study to Evaluate Effects of Microcurrent Therapy on Knee Osteoarthritis
- Conditions
- Osteoarthritis, Knee
- Interventions
- Device: Microcurrent therapy
- Registration Number
- NCT03332914
- Lead Sponsor
- Ludwig-Maximilians - University of Munich
- 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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 13
- osteoarthritis of the knee
- pain intensity > 3 on the numerical rating scale (0-10)
- knee arthroplasty
- gravity
- dermal Irritation at the skin of the knee
- carcinoma
- known osteoarthritis grade 4 (Kellgren and Lawrence score)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description First group Microcurrent therapy control group fisrt and after washing out Microcurrent therapy: Channel A: 100µA; 200 Hz Duration of each treatment session: 30 minutes Number of sessions: 10 Second group Microcurrent therapy Microcurrent therapy: Channel A: 100µA; 200 Hz Duration of each treatment session: 30 minutes Number of sessions: 10 after washing out control group
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Short-Form 36 Change of scores: Before treatment vs. end of treatment (in average 21 days later) Generic HRQOL measure
Range of Motion knee joint Change: Before treatment vs. end of treatment (in average 21 days later) Clinical test with goniometer
Get-up-and-Go-Test (GUG) Change: Before treatment vs. end of treatment (in average 21 days later) clinical test that measures mobility
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.
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
6-minute walking test Change: Before treatment vs. end of treatment (in average 21 days later) Clinical test that measures the Walking ability
Trial Locations
- Locations (1)
Ludwig Maximilian University, University Hosipital, Department of Orthopedics, Physical Medicine and Rehabilitation
🇩🇪Munich, Bavaria, Germany