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The Effects of Transcutaneous Electrical Nerve Stimulation on People With Knee Osteoarthritis (OA) and or Chronic Pain

O

Omron Healthcare

Status

Unknown

Conditions

Knee Pain

Treatments

Device: electrical stimulation
Device: Sham

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT04084236
HDV-CDD-180139

Details and patient eligibility

About

The purpose of this study is to evaluate the effect of TENS at the knee pain.

Enrollment

30 estimated patients

Sex

All

Ages

45+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • 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 criteria

  • 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Single Blind

30 participants in 2 patient groups

Active TENS
Active Comparator group
Treatment:
Device: electrical stimulation
Sham TENS
Sham Comparator group
Treatment:
Device: Sham

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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