A Crossover Designed Study to Evaluate Effects of Microcurrent Therapy on Knee Osteoarthritis

Ludwig Maximilian University of Munich

Status: Completed

Conditions: Osteoarthritis, Knee

Treatments: Device: Microcurrent therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT03332914

MicrocurrencyCrossover

Details and patient eligibility

About

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).

Full 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).

Enrollment: 13 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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13 participants in 2 patient groups

First group

Active Comparator group

Description:

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

Treatment:

Device: Microcurrent therapy

Second group

Active Comparator group

Description:

Microcurrent therapy: Channel A: 100µA; 200 Hz Duration of each treatment session: 30 minutes Number of sessions: 10 after washing out control group

Treatment:

Device: Microcurrent therapy