Clinical trial NCT03332914: A Crossover Designed Study to Evaluate Effects of Microcurrent Therapy on Knee Osteoarthritis
Official title: A Crossover Designed Study to Evaluate Effects of Microcurrent Therapy on Knee Osteoarthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis, Knee
Keywords: Osteoarthritis
microcurrent
knee
electrotherapy
Lead sponsor: Ludwig-Maximilians - University of Munich
Sponsor class: OTHER
Collaborators: name: Federal Ministry for Economic Affairs and Energy
First posted: 2017-11-06
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Crossover
Primary purpose: TREATMENT

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).

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)

Primary outcomes:
measure: Numerical Rating scale (NRS) for pain (0-10)
timeFrame: Change of NRS: Before treatment vs. end of treatment (in average 21 days later)
Secondary outcomes:
measure: Knee injury and Osteoarthritis Outcome Score
timeFrame: Change of scores: Before treatment vs. end of treatment (in average 21 days later
measure: Short-Form 36
timeFrame: Change of scores: Before treatment vs. end of treatment (in average 21 days later)
measure: Satisfaction with Treatment (Questionnaire)
timeFrame: Evaluation at the end of treatment (in average 21 days after Start of treatment)
measure: Range of Motion knee joint
timeFrame: Change: Before treatment vs. end of treatment (in average 21 days later)
measure: Get-up-and-Go-Test (GUG)
timeFrame: Change: Before treatment vs. end of treatment (in average 21 days later)
measure: 6-minute walking test
timeFrame: Change: Before treatment vs. end of treatment (in average 21 days later)
Other outcomes:
Locations:
city: Munich
country: Germany
facility: Ludwig Maximilian University, University Hosipital, Department of Orthopedics, Physical Medicine and Rehabilitation
state: Bavaria
Study officials:
References: