An interventional study of Active TENS and Sham TENS in Knee Pain Chronic and Knee Osteoarthritis, sponsored by Omron Healthcare Co., Ltd.. Status unknown. Open to participants aged 45 Years to 80 Years. Per ClinicalTrials.gov, last updated 2021-09-30.
Sponsored by Omron Healthcare Co., Ltd. · Not applicable, Interventional, and Treatment
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.
4,398 studies on the registry are indexed under Osteoarthritis; 582 are open to participants now.
This study's planned enrollment of 60 is below the median of 70 across 3,440 interventional studies indexed under Osteoarthritis.
Browse Osteoarthritis studies →Omron Healthcare Co., Ltd. is the lead sponsor of 7 studies on the registry; none are open to participants now.
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Exclusion Criteria:
electrical stimulation
Device: Active TENS
no stimulation
Device: Sham TENS
electrical stimulation
no stimulation
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.
Time frame: 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.
Time frame: 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.
Time frame: 10min
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.
Time frame: 10min
No study locations are listed for this record.
This study is status unknown, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.
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Omron Healthcare Co., Ltd.