Status:
UNKNOWN
The Effects of Transcutaneous Electrical Nerve Stimulation on People With Knee Osteoarthritis (OA) and or Chronic Pain
Lead Sponsor:
Omron Healthcare Co., Ltd.
Collaborating Sponsors:
Western Michigan University
Conditions:
Knee Pain
Eligibility:
All Genders
45+ years
Phase:
NA
Brief Summary
The purpose of this study is to evaluate the effect of TENS at the knee pain.
Eligibility Criteria
Inclusion
- Male or Female between the ages of 45 years or older
- Ultrasonography scale of 0-3 for grading of primary Knee OA of the knee(s)
- Pain perceived as a minimum of 3/10 on a 0-10 pain scale with 24 hours of the each visit
- No phobia of electrical stimulation
- No pain or anti-inflammatory medication will be taken during study
- OA and or Chronic knee pain, Injury/pain that began minimum of 6- weeks before the beginning of the study.
Exclusion
- 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 prior to 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 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, lumber disc, herniation, and rheumatoid arthritis)
- The subject does not utilize stairs in daily living
- The subject is unable to walk without ambulatory assistive devices.
Key Trial Info
Start Date :
July 15 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 30 2020
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04084236
Start Date
July 15 2019
End Date
May 30 2020
Last Update
March 16 2020
Active Locations (1)
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1
Omron healthcare Co.,Ltd.
Mukō, Japan