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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Knee Osteoarthritis; Knee Pain Chronic
• Intervention / Treatment: Device: Active TENS; Device: Sham TENS

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Daryl Lawson, PT, DSc; Phone Number: 269 387 7266; Email: daryl.lawson@wmich.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Active TENS; electrical stimulation	Device: Active TENS; electrical stimulation
Sham Comparator: Sham TENS; no stimulation	Device: Sham TENS; no stimulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	10min
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.	15min
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.	10min

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	10min

Collaborators and Investigators

• Sponsor: Omron Healthcare Co., Ltd.
• Collaborators: Western Michigan University

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2021
• Primary Completion (Anticipated): March 1, 2022
• Study Completion (Anticipated): July 1, 2022

Study Registration Dates

• First Submitted: September 21, 2021
• First Submitted That Met QC Criteria: September 21, 2021
• First Posted (Actual): September 30, 2021

Study Record Updates

• Last Update Posted (Actual): September 30, 2021
• Last Update Submitted That Met QC Criteria: September 21, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: HDV-CDD-210023

Drug and device information, study documents

• 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