Clinical trial: Influence of Manual Physical Therapy on Habitual Activity in Knee Osteoarthritis (NCT03573141)

Eligibility criteria:
Inclusion Criteria:

          1. Knee pain and crepitus with active motion and morning stiffness < 30 minutes and age >
             38 years old.

          2. Knee pain and crepitus with active motion and morning stiffness < 30 minutes and bony
             enlargement.

          3. Knee pain and no crepitus and bony enlargement.

        Participants will have to meet all of the following additional inclusion criteria:

          1. Age > 38 years old.

          2. Tricare beneficiary

          3. Ability to read and speak English well enough to provide informed consent and follow
             study instructions

          4. Knee OA is the participant's most physically limiting condition as determined by
             patient's self report.

          5. Able to ambulate 20 meters (65.6 feet) feet without an assistive device.

          6. Radiographic findings of knee OA

        Exclusion Criteria:

          -  1.) Presence of any medical "Red Flags" affecting the knee:

               1. Tumor, neoplasm etc. affecting the knee

               2. Current or past history of rheumatoid arthritis or similar rheumatic condition

               3. Current or past history of gout or pseudogout affecting the knee

               4. Active Infection in the knee within the past 12 months

                  2.) Inability to participate in the therapy plan prescribed by the treating
                  therapist 3.) Any prior Physical Therapy for the knee in the past 12 months 4.)
                  Injection to the knee joint within the previous 30 days 5.) Surgical procedure on
                  either lower extremity within the past 6 months 6.) Any prior lower extremity
                  joint replacement surgery 7.) A physical impairment unrelated to the knee that
                  prevents the subject from safely participating in any aspect of the study 8.)
                  History of cardiac, respiratory, or musculoskeletal disorders (e.g. amputation)
                  that restrict lower extremity function. 9.) Any physical, psychological, or
                  emotional condition that is more symptom producing, or activity limiting than
                  their knee OA.

                  10.) Any condition that disrupts sleep more than knee OA, such as a sleep
                  disorder or Obstructive Sleep Apnea 11.) Inability to speak/read English
                  adequately to understand and provide informed consent 12.) Pregnant or intending
                  to become pregnant in the next year 13.) Military service members in a WTU
                  (Warriors in Transition Unit) or service equivalent or pending a medical
                  evaluation board/discharge process. For non-military personnel, anyone that is
                  pending or undergoing any litigation. 14.) WOMAC Score < 30 15.) Unable to
                  provide informed consent to participate in the study
No condition on gender to be admitted to the trial.




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? Contradiction