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NCT Number: NCT03332914

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

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).

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Key information

Conditions

Osteoarthritis, Knee Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Rheumatic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Munich, Bavaria, 81377, Germany

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Microcurrent therapy

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.

Primary outcomes

  1. Numerical Rating scale (NRS) for pain (0-10)

    Time frame: Change of NRS: Before treatment vs. end of treatment (in average 21 days later)

    numerical Rating scale

Secondary outcomes

  1. Knee injury and Osteoarthritis Outcome Score

    Time frame: Change of scores: Before treatment vs. end of treatment (in average 21 days later

    Knee specific Instrument measuring pan, function and Quality of life.

  2. Short-Form 36

    Time frame: Change of scores: Before treatment vs. end of treatment (in average 21 days later)

    Generic HRQOL measure

  3. Satisfaction with Treatment (Questionnaire)

    Time frame: Evaluation at the end of treatment (in average 21 days after Start of treatment)

    Self-administered questionnaire that was developed for this study

  4. Range of Motion knee joint

    Time frame: Change: Before treatment vs. end of treatment (in average 21 days later)

    Clinical test with goniometer

  5. Get-up-and-Go-Test (GUG)

    Time frame: Change: Before treatment vs. end of treatment (in average 21 days later)

    clinical test that measures mobility

  6. 6-minute walking test

    Time frame: Change: Before treatment vs. end of treatment (in average 21 days later)

    Clinical test that measures the Walking ability

Sponsors and collaborators

Lead sponsor

Ludwig-Maximilians - University of Munich

Other

Collaborators

  • Federal Ministry for Economic Affairs and Energy

Registry information

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Nov 6, 2017
Registry last updated
Aug 13, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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