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

Osteoarthritis, Knee Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03332914
• Other study ID #: MicrocurrencyCrossover
• Status: Completed
• Phase: N/A
• Start date: November 2, 2017
• Est. completion date: December 27, 2017

Study information

• Verified date: August 2019
• Source: Ludwig-Maximilians - University of Munich
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: December 27, 2017
• Est. primary completion date: November 27, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Knee

Intervention

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.

Locations

Country	Name	City	State
Germany	Ludwig Maximilian University, University Hosipital, Department of Orthopedics, Physical Medicine and Rehabilitation	Munich	Bavaria

Sponsors (2)

Lead Sponsor	Collaborator
Ludwig-Maximilians - University of Munich	Federal Ministry for Economic Affairs and Energy

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Short-Form 36	Generic HRQOL measure	Change of scores: Before treatment vs. end of treatment (in average 21 days later)
Secondary	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)
Secondary	Range of Motion knee joint	Clinical test with goniometer	Change: Before treatment vs. end of treatment (in average 21 days later)
Secondary	Get-up-and-Go-Test (GUG)	clinical test that measures mobility	Change: Before treatment vs. end of treatment (in average 21 days later)
Secondary	6-minute walking test	Clinical test that measures the Walking ability	Change: Before treatment vs. end of treatment (in average 21 days later)