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

NCT ID: NCT03332914

Last Updated: 2019-08-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

13 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-02

Study Completion Date

2017-12-27

Brief Summary

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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

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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).

Conditions

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Osteoarthritis, Knee

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Crossover
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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First group

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

Group Type ACTIVE_COMPARATOR

Microcurrent therapy

Intervention Type DEVICE

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.

Second group

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

after washing out control group

Group Type ACTIVE_COMPARATOR

Microcurrent therapy

Intervention Type DEVICE

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.

Interventions

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Microcurrent 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.

Intervention Type DEVICE

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Federal Ministry for Economic Affairs and Energy

OTHER

Sponsor Role collaborator

Ludwig-Maximilians - University of Munich

OTHER

Sponsor Role lead

Responsible Party

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PD Dr. Martin Weigl, MPH

PD, MD, MPH (Harvard University)

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Ludwig Maximilian University, University Hosipital, Department of Orthopedics, Physical Medicine and Rehabilitation

Munich, Bavaria, Germany

Site Status

Countries

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Germany

Other Identifiers

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MicrocurrencyCrossover

Identifier Type: -

Identifier Source: org_study_id

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