Microcurrent Therapy in the Treatment of Osteoarthritis of the Knee

Not Applicable

Completed

• Conditions: Osteoarthritis,Knee
• Interventions: Device: Microcurrent therapy

• Registration Number: NCT02975154
• Lead Sponsor: Ludwig-Maximilians - University of Munich

Brief Summary

This study evaluates the effect of Microcurrent Therapy in the treatment of osteoarthritis of the knee. Patients will be randomized to four groups: Group 1 and 2 both will receive Microcurrent Therapy, but different currents will be used. Group 3 will receive treatment with the Microcurrent treatment apparatus, but without any current. Group 4 will be a control group without specific interventions.

Detailed Description

The objective of this randomized, controlled pilot study is to evaluate the effect of Microcurrent therapy on pain and physical function in patients with osteoarthritis of the knee. The secondary objective is to compare the effects of different currents. Patients will be randomized to four groups: Group 1 and 2 both will receive Microcurrent Therapy, but different currents will be used. Group 3 will receive treatment with the Microcurrent treatment apparatus, but without any current. Group 4 will be a control group without specific intervention.

Group 1, 2 and 3 will receive 10 sessions of treatment in a treatment phase of four weeks. Assessments for group 1, 2, and 3 will be scheduled for screening (T0), at the first day of treatment (T1), at the end of treatment (T2) and three months after the end of treatment (T3). Group 4 will be assessed at a screening visit T0, at T1, at T2 (approximately 21 days after T1), and at T3 (three months after T2). Patients will be recruited based on the records of the clinic.

Study Timeline

• Study First Submitted: 2016-11-21
• Study First Submitted QC: 2016-11-23
• Study First Posted: 2016-11-29
• Study Start: 2016-12-05
• Primary Completion: 2017-09-04
• Study Completion: 2017-09-04
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-11
• Last Update Posted: 2017-10-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 56

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Microcurrent therapy, type A	Microcurrent therapy	Microcurrent therapy: Channel A: 100 µA; 200 Hz; Channel B: 100 µA; 300 Hz. Duration of each treatment session: 30 minutes. Number of sessions: 10. Previous treatments will be continued.
Sham Microcurrent therapy	Microcurrent therapy	Microcurrent therapy: Channel A: 0 µA; 0 Hz; Channel B: 0 µA; 0 Hz. Duration of each treatment session: 30 minutes. Number of sessions: 10. Previous treatments will be continued.
Microcurrent therapy, type B	Microcurrent therapy	Microcurrent therapy: Channel A: 25 µA; 200 Hz; Channel B: 100 µA; 300 Hz. Duration of each treatment session: 30 minutes. Number of sessions: 10. Previous treatments will be continued.

Primary Outcome Measures

Name	Time	Method
Numerical Ratings scale (NRS) for pain (0-10)	Change of NRS: Before treatment vs. end of treatment (in average 21 days later)	numerical Rating scale

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Ludwig Maximilian University, University Hosipital, Department of Orthopedics, Physical Medicine and Rehabilitation; 🇩🇪 Munich, Germany