Clinical trial: Sleep, Pain and Inflammatory Processes in Older Adults With Osteoarthritis (NCT01683799)

Eligibility criteria:
Inclusion Criteria:

          -  50-75 years of age (for women, post-menopausal)

          -  Kellgren-Lawrence grade II radiographic evidence of OA affecting one or both knees

          -  knee pain on most days for ≥ 6 months

          -  self-reported disability due to knee pain for ≥ 2 of the following: walking, kneeling,
             ascending or descending stairs, or performing daily activities

          -  willing and able to avoid all prescription and non-prescription, non-opiate pain
             medication for 48 hours prior to testing and all narcotic pain medication for 2 weeks
             prior to testing

          -  meets research diagnostic criteria for sleep maintenance insomnia

        Exclusion Criteria:

          -  health conditions with immunological components or undergoing or taking
             immunosuppressive therapies

          -  conditions contraindicated for or potentially limiting ability to conduct NFR and/or
             cold pressor test (e.g. Raynaud's syndrome; seizures; prior MI; respiratory
             conditions; leg/hip nerve damage; BMI ≥ 32)

          -  sleep disorders other than insomnia

          -  dementia or cognitive impairment

          -  history of schizophrenia or bipolar I disorder; current or recent history (within 3
             months) of major psychiatric disorders

          -  current depressive symptomatology or current suicidality

          -  active substance dependence

          -  untreated hypertension

          -  use of antidepressants (stable use for 3 months okay), antipsychotics, mood
             stabilizers, sedative-hypnotics, opiate analgesics
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 50 Years old.
Subject must be at most 75 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? Entailment