Back to resultsA Crossover Designed Study to Evaluate Effects of Microcurrent Therapy on Knee Osteoarthritis
Primary Purpose
Osteoarthritis, Knee
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Microcurrent therapy
Sponsored by
About this trial
This is an interventional treatment trial for Osteoarthritis, Knee focused on measuring Osteoarthritis, microcurrent, knee, electrotherapy
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)
Sites / Locations
- Ludwig Maximilian University, University Hosipital, Department of Orthopedics, Physical Medicine and Rehabilitation
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
First group
Second group
Arm 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
Microcurrent therapy: Channel A: 100µA; 200 Hz Duration of each treatment session: 30 minutes Number of sessions: 10 after washing out control group
Outcomes
Primary Outcome Measures
Numerical Rating scale (NRS) for pain (0-10)
numerical Rating scale
Secondary Outcome Measures
Knee injury and Osteoarthritis Outcome Score
Knee specific Instrument measuring pan, function and Quality of life.
Short-Form 36
Generic HRQOL measure
Satisfaction with Treatment (Questionnaire)
Self-administered questionnaire that was developed for this study
Range of Motion knee joint
Clinical test with goniometer
Get-up-and-Go-Test (GUG)
clinical test that measures mobility
6-minute walking test
Clinical test that measures the Walking ability
Full Information
NCT ID
NCT03332914
First Posted
November 2, 2017
Last Updated
August 12, 2019
Sponsor
Ludwig-Maximilians - University of Munich
Collaborators
Federal Ministry for Economic Affairs and Energy
1. Study Identification
Unique Protocol Identification Number
NCT03332914
Brief Title
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
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
November 2, 2017 (Actual)
Primary Completion Date
November 27, 2017 (Actual)
Study Completion Date
December 27, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ludwig-Maximilians - University of Munich
Collaborators
Federal Ministry for Economic Affairs and Energy
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Knee
Keywords
Osteoarthritis, microcurrent, knee, electrotherapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Crossover
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
13 (Actual)
8. Arms, Groups, and Interventions
Arm Title
First group
Arm Type
Active Comparator
Arm 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
Arm Title
Second group
Arm Type
Active Comparator
Arm Description
Microcurrent therapy: Channel A: 100µA; 200 Hz Duration of each treatment session: 30 minutes Number of sessions: 10
after washing out control group
Intervention Type
Device
Intervention Name(s)
Microcurrent therapy
Intervention Description
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 Outcome Measure Information:
Title
Numerical Rating scale (NRS) for pain (0-10)
Description
numerical Rating scale
Time Frame
Change of NRS: Before treatment vs. end of treatment (in average 21 days later)
Secondary Outcome Measure Information:
Title
Knee injury and Osteoarthritis Outcome Score
Description
Knee specific Instrument measuring pan, function and Quality of life.
Time Frame
Change of scores: Before treatment vs. end of treatment (in average 21 days later
Title
Short-Form 36
Description
Generic HRQOL measure
Time Frame
Change of scores: Before treatment vs. end of treatment (in average 21 days later)
Title
Satisfaction with Treatment (Questionnaire)
Description
Self-administered questionnaire that was developed for this study
Time Frame
Evaluation at the end of treatment (in average 21 days after Start of treatment)
Title
Range of Motion knee joint
Description
Clinical test with goniometer
Time Frame
Change: Before treatment vs. end of treatment (in average 21 days later)
Title
Get-up-and-Go-Test (GUG)
Description
clinical test that measures mobility
Time Frame
Change: Before treatment vs. end of treatment (in average 21 days later)
Title
6-minute walking test
Description
Clinical test that measures the Walking ability
Time Frame
Change: Before treatment vs. end of treatment (in average 21 days later)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Facility Information:
Facility Name
Ludwig Maximilian University, University Hosipital, Department of Orthopedics, Physical Medicine and Rehabilitation
City
Munich
State/Province
Bavaria
ZIP/Postal Code
81377
Country
Germany
12. IPD Sharing Statement
Plan to Share IPD
No
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A Crossover Designed Study to Evaluate Effects of Microcurrent Therapy on Knee Osteoarthritis
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