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

Primary Purpose

Knee Pain Chronic, Knee Osteoarthritis

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Active TENS
Sham TENS
Sponsored by
Omron Healthcare Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Pain Chronic

Eligibility Criteria

45 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Exclusion Criteria:

  • Exclusion criteria for the subjects: 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 before 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 other 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, lumbar disc, herniation, and rheumatoid arthritis) or do not utilize stairs in daily living and unable to walk without ambulatory assistive devices. The candidate will be disqualified as a subject for the study if less than 5 days of pedometer use or less than 5 days VAS reporting within the prior week's baseline period.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Sham Comparator

    Arm Label

    Active TENS

    Sham TENS

    Arm Description

    electrical stimulation

    no stimulation

    Outcomes

    Primary Outcome Measures

    Knee pain evaluated using the VAS for the stair climb test.
    The mean knee pain during the stair climb test is timed up and go test, and the 6-minute walk test will be measured using the VAS. Participants will record their level of knee pain by drawing a vertical mark between the ends of a 10-cm horizontal line. The 0-cm end and the 10-cm end represented no pain and the most extreme pain, respectively. The distance from the 0-cm end to the drawn mark was recorded to the first decimal place.
    6-minute walk test (6MWT)
    In the 6-minute walk test, the participants will walk as far as they could within 6 minutes. They will be not allowed to carry a watch or provided feedback during the trial. Although rest periods are allowed, time recording will continue. The participants will be encouraged at 1-minute intervals. Their performance will be measured as the total distance traveled, and be recorded as an integral number.
    Timed Up and Go (TUG) test
    The participant will sit down at first and then stand up when given the signal to start. As fast as possible, the participant will walk 3 meters toward a cone on the floor, circle it, walk back 3 more meters toward a chair, and finally sat sit down. Timing begins on the signal to start and ends when the participant completely sits down with their back resting on the backrest of the chair. Two trials will be performed, and the faster time of the 2 trials will be recorded to the nearest one-hundredth of a second.

    Secondary Outcome Measures

    knee extensor strength
    The maximum isometric knee extensor strengths will be measured using a handheld dynamometer (HHD), which is the validated method in previous research on elderly individuals who are prone to falls.15 The maximum force will be recorded in Newtons (N), and testing will be repeated for 2 measurements. The averaged value of 2 measurements was used for statistical analysis.

    Full Information

    First Posted
    September 21, 2021
    Last Updated
    September 21, 2021
    Sponsor
    Omron Healthcare Co., Ltd.
    Collaborators
    Western Michigan University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05062499
    Brief Title
    The Effects of Home Use of Transcutaneous Electrical Nerve Stimulation on People With Knee OA and or Chronic Knee Pain
    Official Title
    The Effects of Home Use of Transcutaneous Electrical Nerve Stimulation on People With Knee Osteoarthritis (OA) and or Chronic Knee Pain
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2021
    Overall Recruitment Status
    Unknown status
    Study Start Date
    September 2021 (Anticipated)
    Primary Completion Date
    March 2022 (Anticipated)
    Study Completion Date
    July 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Omron Healthcare Co., Ltd.
    Collaborators
    Western Michigan University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    Yes
    Product Manufactured in and Exported from the U.S.
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Knee Pain Chronic, Knee Osteoarthritis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Active TENS
    Arm Type
    Active Comparator
    Arm Description
    electrical stimulation
    Arm Title
    Sham TENS
    Arm Type
    Sham Comparator
    Arm Description
    no stimulation
    Intervention Type
    Device
    Intervention Name(s)
    Active TENS
    Intervention Description
    electrical stimulation
    Intervention Type
    Device
    Intervention Name(s)
    Sham TENS
    Intervention Description
    no stimulation
    Primary Outcome Measure Information:
    Title
    Knee pain evaluated using the VAS for the stair climb test.
    Description
    The mean knee pain during the stair climb test is timed up and go test, and the 6-minute walk test will be measured using the VAS. Participants will record their level of knee pain by drawing a vertical mark between the ends of a 10-cm horizontal line. The 0-cm end and the 10-cm end represented no pain and the most extreme pain, respectively. The distance from the 0-cm end to the drawn mark was recorded to the first decimal place.
    Time Frame
    10min
    Title
    6-minute walk test (6MWT)
    Description
    In the 6-minute walk test, the participants will walk as far as they could within 6 minutes. They will be not allowed to carry a watch or provided feedback during the trial. Although rest periods are allowed, time recording will continue. The participants will be encouraged at 1-minute intervals. Their performance will be measured as the total distance traveled, and be recorded as an integral number.
    Time Frame
    15min
    Title
    Timed Up and Go (TUG) test
    Description
    The participant will sit down at first and then stand up when given the signal to start. As fast as possible, the participant will walk 3 meters toward a cone on the floor, circle it, walk back 3 more meters toward a chair, and finally sat sit down. Timing begins on the signal to start and ends when the participant completely sits down with their back resting on the backrest of the chair. Two trials will be performed, and the faster time of the 2 trials will be recorded to the nearest one-hundredth of a second.
    Time Frame
    10min
    Secondary Outcome Measure Information:
    Title
    knee extensor strength
    Description
    The maximum isometric knee extensor strengths will be measured using a handheld dynamometer (HHD), which is the validated method in previous research on elderly individuals who are prone to falls.15 The maximum force will be recorded in Newtons (N), and testing will be repeated for 2 measurements. The averaged value of 2 measurements was used for statistical analysis.
    Time Frame
    10min

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    45 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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. Exclusion Criteria: Exclusion criteria for the subjects: 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 before 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 other 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, lumbar disc, herniation, and rheumatoid arthritis) or do not utilize stairs in daily living and unable to walk without ambulatory assistive devices. The candidate will be disqualified as a subject for the study if less than 5 days of pedometer use or less than 5 days VAS reporting within the prior week's baseline period.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Daryl Lawson, PT, DSc
    Phone
    269 387 7266
    Email
    daryl.lawson@wmich.edu

    12. IPD Sharing Statement

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

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