Efficacy of Microcurrent Therapy for Treatment of Knee Pain | NCT03511014

Studies
Efficacy of Microcurrent Therapy for Treatment of Knee Pain

NCT03511014

Sponsor

Omron Healthcare Co., Ltd.

Status

Unknown status

Last Update Posted

Apr 27, 2018Actual

Enrollment

70Estimated

Phase

Not Applicable

Conditions

Acute Knee Pain

Interventions

Microcurrent

Countries

Japan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2018

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 1, 2018Actual

Primary Completion Date

Jul 31, 2018Estimated

Completion Date

Feb 1, 2019Estimated

First Submitted Date

Apr 17, 2018

First Submission Date that Met QC Criteria

Apr 17, 2018

First Posted Date

Apr 27, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 17, 2018

Last Update Posted Date

Apr 27, 2018Actual

Name	Class
Elon University, Department of Physical Therapy Education	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

70Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
microcurrent	Experimental		Device: Microcurrent
control	Sham Comparator		Device: Microcurrent

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Microcurrent	Device	Micrucurrent will be apply	control microcurrent

Measure	Description	Time Frame
Numeric Pain scale (NRS) for pain (0-10)		4weeks

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Pain perceived as a minimum of 3/10 on a 0-10 pain scale
No phobia of electrical stimulation
No pain or anti-inflammatory medication will be taken during study
Injury that began prior to 6-weeks ago before the onset of pain
Grade II soft tissue injury

Exclusion Criteria:

Pregnancy
Diabetes Mellitus
Neuropathy
Smoker
Uncontrolled HTN
Past surgery in the region to be treated by microcurrent
Arthritis (RA) in the area to be treated by microcurrent
Cardiovascular disease
Allergic to tape/electrodes
Ligament injury
Patella Femoral Pain Syndrome (Anterior knee pain)
Dementia
Grade III soft tissue injury

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Omron healthcare Co.,Ltd.	Recruiting	Mukō			Japan