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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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05062499
Enrollment
60
Registered
2021-09-30
Start date
2021-09-30
Completion date
2022-07-31
Last updated
2021-09-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Knee Pain Chronic, Knee Osteoarthritis

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.

Interventions

electrical stimulation

DEVICESham TENS

no stimulation

Sponsors

Western Michigan University
CollaboratorOTHER
Omron Healthcare Co., Ltd.
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
45 Years to 80 Years
Healthy volunteers
No

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

*

Design outcomes

Primary

MeasureTime frameDescription
Knee pain evaluated using the VAS for the stair climb test.10minThe 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)15minIn 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) test10minThe 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

MeasureTime frameDescription
knee extensor strength10minThe 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.

Contacts

Primary ContactDaryl Lawson, PT, DSc
daryl.lawson@wmich.edu269 387 7266

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026