The Effects of Transcutaneous Electrical Nerve Stimulation on People With Knee Osteoarthritis (OA) and or Chronic Pain

NCT ID: NCT04084236

Last Updated: 2020-03-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-15

Study Completion Date

2020-05-30

Brief Summary

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

Detailed Description

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Conditions

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Knee Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Active TENS

Group Type ACTIVE_COMPARATOR

electrical stimulation

Intervention Type DEVICE

electrical stimulation

Sham TENS

Group Type SHAM_COMPARATOR

Sham

Intervention Type DEVICE

no stimulation

Interventions

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electrical stimulation

electrical stimulation

Intervention Type DEVICE

Sham

no stimulation

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Male or Female between the ages of 45 years or older
* Ultrasonography scale of 0-3 for grading of primary Knee OA of the knee(s)
* Pain perceived as a minimum of 3/10 on a 0-10 pain scale with 24 hours of the each visit
* No phobia of electrical stimulation
* No pain or anti-inflammatory medication will be taken during study
* OA and or Chronic knee pain, Injury/pain that began minimum of 6- weeks before the beginning of the study.

Exclusion Criteria

* Pregnancy
* Diabetes Mellitus
* Neuropathy
* Smoker
* Uncontrolled HTN
* Past surgery in the region to be treated by TENS or had received an intra-articular corticosteroid or hyaluronic acid injection within 6 months prior to enrollment
* Arthritis (RA) in the area to be treated by TENS
* Allergic to tape/electrodes
* Dementia
* History of knee joint replacement or tibial osteotomy
* Undergoing physical therapy
* Any major joint pain (e.g., back, hip, or ankle) that could limit functional ability
* Contraindications to TENS (pacemakers, dermatological conditions, and abnormal sensation in the knees)
* Severe medical or neurological conditions (e.g. Chronic obstructive pulmonary disease, cardiovascular disease, arteriosclerosis obliterans, cerebrovascular accident, lumber disc, herniation, and rheumatoid arthritis)
* The subject does not utilize stairs in daily living
* The subject is unable to walk without ambulatory assistive devices.
Minimum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Western Michigan University

OTHER

Sponsor Role collaborator

Omron Healthcare Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Omron healthcare Co.,Ltd.

Mukō, , Japan

Site Status RECRUITING

Countries

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Japan

Facility Contacts

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Shozo Takamatsu

Role: primary

+81-75-925-2043

Keisuke Yamada

Role: backup

+81-75-925-2043

Other Identifiers

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HDV-CDD-180139

Identifier Type: -

Identifier Source: org_study_id

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