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).

Study Overview

• Status: Completed
• Conditions: Osteoarthritis, Knee
• Intervention / Treatment: Device: Microcurrent therapy

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).

• Study Type: Interventional
• Enrollment (Actual): 13
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Bavaria
    • Munich, Bavaria, Germany, 81377
      • Ludwig Maximilian University, University Hosipital, Department of Orthopedics, Physical Medicine and Rehabilitation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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	Device: 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.
Active Comparator: 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	Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Numerical Rating scale (NRS) for pain (0-10)	numerical Rating scale	Change of NRS: Before treatment vs. end of treatment (in average 21 days later)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Short-Form 36	Generic HRQOL measure	Change of scores: Before treatment vs. end of treatment (in average 21 days later)
Satisfaction with Treatment (Questionnaire)	Self-administered questionnaire that was developed for this study	Evaluation at the end of treatment (in average 21 days after Start of treatment)
Range of Motion knee joint	Clinical test with goniometer	Change: Before treatment vs. end of treatment (in average 21 days later)
Get-up-and-Go-Test (GUG)	clinical test that measures mobility	Change: Before treatment vs. end of treatment (in average 21 days later)
6-minute walking test	Clinical test that measures the Walking ability	Change: Before treatment vs. end of treatment (in average 21 days later)
Knee injury and Osteoarthritis Outcome Score	Knee specific Instrument measuring pan, function and Quality of life.	Change of scores: Before treatment vs. end of treatment (in average 21 days later

Collaborators and Investigators

• Sponsor: Ludwig-Maximilians - University of Munich
• Collaborators: Federal Ministry for Economic Affairs and Energy

Study record dates

Study Major Dates

• Study Start (Actual): November 2, 2017
• Primary Completion (Actual): November 27, 2017
• Study Completion (Actual): December 27, 2017

Study Registration Dates

• First Submitted: November 2, 2017
• First Submitted That Met QC Criteria: November 2, 2017
• First Posted (Actual): November 6, 2017

Study Record Updates

• Last Update Posted (Actual): August 13, 2019
• Last Update Submitted That Met QC Criteria: August 12, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Keywords: Osteoarthritis; knee; microcurrent; electrotherapy
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: MicrocurrencyCrossover

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No