NCT03511014

Brief Summary

The purpose of this study is to evaluate the effect of microcurrent therapy at the knee pain.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2018

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2018

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 17, 2018

Completed
10 days until next milestone

First Posted

Study publicly available on registry

April 27, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2018

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2019

Completed
Last Updated

April 27, 2018

Status Verified

April 1, 2018

Enrollment Period

5 months

First QC Date

April 17, 2018

Last Update Submit

April 17, 2018

Conditions

Acute Knee Pain

Outcome Measures

Primary Outcomes (1)

  • Numeric Pain scale (NRS) for pain (0-10)

    4weeks

Study Arms (2)

microcurrent

EXPERIMENTAL
Device: Microcurrent

control

SHAM COMPARATOR
Device: Microcurrent

Interventions

MicrocurrentDEVICE

Micrucurrent will be apply

controlmicrocurrent

Eligibility Criteria

Age21 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Omron healthcare Co.,Ltd.

Mukō, Japan

RECRUITING

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 17, 2018

First Posted

April 27, 2018

Study Start

March 1, 2018

Primary Completion

July 31, 2018

Study Completion

February 1, 2019

Last Updated

April 27, 2018

Record last verified: 2018-04

Locations

JP(1)