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

Omron Healthcare

Status: Unknown

Conditions: Knee Pain Chronic; Knee Osteoarthritis

Treatments: Device: Sham TENS; Device: Active TENS

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05062499

HDV-CDD-210023

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 45 to 80 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

Active TENS

Active Comparator group

Description:

electrical stimulation

Treatment:

Device: Active TENS

Sham TENS

Sham Comparator group

Description:

no stimulation

Treatment:

Device: Sham TENS