Clinical trial: Effects of tDCS and tUS on Pain Perception in OA of the Knee (NCT02330315)

Eligibility criteria:
Inclusion Criteria:

          1. Able to provide informed consent to participate in the study.

          2. Subjects between 18-85 years old.

          3. Diagnosis of chronic osteoarthritis with pain of either the knee as self-reported.

             Prior to beginning baseline procedures this must be confirmed by medical records or a
             letter from the subject's physician. This document may either be brought in by the
             subject or retrieved by study staff after a medical release form is signed by the
             subject. After consent, if the subject fails to provide the necessary documentation or
             it cannot be retrieved by study staff the subject will be considered a screen fail.

          4. Existing knee pain in the past 6 months of at least 3 on a 0-10 VAS scale on average.

          5. Pain resistant to common analgesics and medications for chronic pain used as initial
             pain management such as Tylenol, Aspirin, Ibuprofen, Soma, Parafon Forte DCS,
             Zanaflex, and Codeine.

          6. Having the ability to feel pain as self-reported

        Exclusion Criteria:

          1. Pregnancy or trying to become pregnant in the next 6 months.

          2. History of alcohol or drug abuse within the past 6 months as self-reported.

          3. Contraindications to transcranial brain stimulation or TUS, i.e. implanted brain
             medical devices or implanted brain metallic devices.

          4. Unstable medical conditions (e.g. uncontrolled diabetes, uncompensated cardiac issues,
             heart failure or chronic obstructive pulmonary disease).

          5. Epilepsy.

          6. Use of carbamazepine within the past 6 months as self-reported.

          7. Suffering from severe depression (with a score of >30 in the Beck Depression
             Inventory)

          8. History of unexplained fainting spells as self-reported.

          9. Head injury resulting in more than a momentary loss of consciousness

         10. History of neurosurgery as self-reported.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 85 Years

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? 1