Clinical trial: The Effects of Transcutaneous Electrical Nerve Stimulation on People With Knee Osteoarthritis (OA) and or Chronic Pain (NCT04084236)

Eligibility criteria:
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.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 45 Years old.


Patient description (medical language): A 66-year-old woman comes to the office due to joint pain in the hands and periodic morning stiffness that lasts less than 15 minutes.  The pain is moderately severe and worsens with daily activity. The patient used Tylenol with minimal relief.  Past medical history is notable for hypertension and hypercholesteremia.  Physical examination shows firm nodules over the distal interphalangeal joints, bilaterally. The patient has pain in her knees as well. The knees are stiff in the morning for less than 30 minutes and become worse with climbing stairs. She has some sensation of bone friction during activity. X-ray shows narrowing of the joint space, subchondral bone sclerosis and osteophyte formation along the joints.

Patient description (patient's own words): I'm a 66-year-old woman and I went to my doctor's office because of a bloody joint pain in my hands that has been lasting for a while. The pain comes and go in the morning usually. I feel like a stiffness that last less than 15 minutes. The pain is moderately severe but it gets worse when I'm using my hands. I used Tylenol which helped a little. Apart from that, I suffer from hypertension and high cholesterol. The doctor made me notice that I have bumps around both of my hand joints. I also suffer from my knees and they are also stiff in the morning for around 30 min. It's even worse when I climb up the stairs! I also feel like my bones are rubbing against each other when I'm moving. The X-ray showed that I have narrow joint space, I have sclerosis, and abnormal growths of bone along my joints.

Does the patient match the trial criteria? Entailment