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

NCT05062499 | Unknown FDA Device

• 1 other identifier: HDV-CDD-210023
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Knee Pain Chronic; Knee Osteoarthritis

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• knee extensor strength

  10min

Study Arms (2)

Active TENS

ACTIVE COMPARATOR

electrical stimulation

Device: Active TENS

Sham TENS

SHAM COMPARATOR

no stimulation

Device: Sham TENS

Interventions

Active TENS DEVICE

electrical stimulation

Active TENS

Sham TENS DEVICE

no stimulation

Sham TENS

Eligibility Criteria

• Age: 45 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• Omron Healthcare Co., Ltd.: lead
• Western Michigan University: collaborator

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Central Study Contacts

Daryl Lawson, PT, DSc

CONTACT

269 387 7266; daryl.lawson@wmich.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 21, 2021
• First Posted: September 30, 2021
• Study Start: September 1, 2021
• Primary Completion: March 1, 2022
• Study Completion: July 1, 2022
• Last Updated: September 30, 2021

Record last verified: 2021-09