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Microcurrent Therapy in the Treatment of Osteoarthritis of the Knee

Primary Purpose

Osteoarthritis,Knee

Status

Completed

Phase

Not Applicable

Locations

Germany

Study Type

Interventional

Intervention

Microcurrent therapy

About this trial

This is an interventional treatment trial for Osteoarthritis,Knee focused on measuring osteoarthritis, microcurrent, knee, electrotherapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 3

Arm 4

Arm Type

Active Comparator

Sham Comparator

No Intervention

Arm Label

Microcurrent therapy, type A

Microcurrent therapy, type B

Sham Microcurrent therapy

No Intervention

Arm Description

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.

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.

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.

No Intervention. Previous treatments will be continued.

Outcomes

Primary Outcome Measures

Numerical Ratings 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

NCT02975154

First Posted

November 21, 2016

Last Updated

October 11, 2017

Sponsor

Ludwig-Maximilians - University of Munich

Collaborators

Federal Ministry for Economic Affairs and Energy

1. Study Identification

Unique Protocol Identification Number

NCT02975154

Brief Title

Microcurrent Therapy in the Treatment of Osteoarthritis of the Knee

Official Title

Microcurrent Therapy in the Treatment of Osteoarthritis of the Knee: a Randomized, Controlled Pilot Study

Study Type

Interventional

2. Study Status

Record Verification Date

October 2017

Overall Recruitment Status

Completed

Study Start Date

December 5, 2016 (Actual)

Primary Completion Date

September 4, 2017 (Actual)

Study Completion Date

September 4, 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

Data Monitoring Committee

5. Study Description

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.

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

Parallel Assignment

Masking

ParticipantCare ProviderOutcomes Assessor

Allocation

Randomized

Enrollment

56 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Microcurrent therapy, type A

Arm Type

Active Comparator

Arm Description

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.

Arm Title

Microcurrent therapy, type B

Arm Type

Active Comparator

Arm Description

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.

Arm Title

Sham Microcurrent therapy

Arm Type

Sham Comparator

Arm Description

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.

Arm Title

No Intervention

Arm Type

No Intervention

Arm Description

No Intervention. Previous treatments will be continued.

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 Ratings 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

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)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Martin B Weigl

Organizational Affiliation

Department of Orthopedics, Physical Medicine and Rehabilitation, University Hospital Munich, Ludwig Maximilians University Munich

Official's Role

Principal Investigator

Facility Information:

Facility Name

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

City

Munich

ZIP/Postal Code

81377

Country

Germany

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Microcurrent Therapy in the Treatment of Osteoarthritis of the Knee

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