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The Effects of Home Use of Transcutaneous Electrical Nerve Stimulation on People With Knee OA and or Chronic Knee Pain

NCT ID: NCT05062499

Last Updated: 2021-09-30

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

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-30

Study Completion Date

2022-07-31

Brief Summary

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The purpose of the research is to see if the use of transcutaneous electrical nerve stimulation (TENS) at home would reduce knee pain and swelling in people with knee OA and/or chronic knee pain.

Detailed Description

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Conditions

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Knee Pain Chronic Knee Osteoarthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Active TENS

electrical stimulation

Group Type ACTIVE_COMPARATOR

Active TENS

Intervention Type DEVICE

electrical stimulation

Sham TENS

no stimulation

Group Type SHAM_COMPARATOR

Sham TENS

Intervention Type DEVICE

no stimulation

Interventions

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Active TENS

electrical stimulation

Intervention Type DEVICE

Sham TENS

no stimulation

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* The inclusionary criteria for subjects: Male or Female with the age of 45 years or older, ultrasonography scale of 0-3 for grading of primary Knee OA of the knees, pain perceived as a minimum of 3/10 and a maximum of 7/10 weekly average during the baseline period on a 0-10 active VAS pain scale, no phobia of electrical stimulation, no pain or anti-inflammatory medication will be taken during the study. Injury/pain that began at the knee a minimum of 6-weeks before entering the study.
Minimum Eligible Age

45 Years

Maximum Eligible Age

80 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

Central Contacts

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Daryl Lawson, PT, DSc

Role: CONTACT

Phone: 269 387 7266

Email: [email protected]

Other Identifiers

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HDV-CDD-210023

Identifier Type: -

Identifier Source: org_study_id