Table 1 Eligibility criteria of the EXERPHARMA-trial
Inclusion criteria | |
1. | |
a) | Risk factors: Age >40 years; female; overweight; occupation; family history of OA |
b) | Symptoms: persistent knee pain; brief morning stiffness; functional limitations; acute knee pain |
c) | Objective examination: crepitus during active movement; bony tenderness; bony enlargement; palpable effusion; no palpable warmth; restricted movement; instability. |
2. | No, mild, or moderate medial knee OA defined as “No osteoarthritis”, “Doubtful narrowing of joint space and/or possible osteophytes”, “Definite osteophytes and possible narrowing of joint space”, “Multiple osteophytes, definite narrowing of joint space, and some sclerosis and deformity of bone ends.” This corresponds to the modification of Kellgren and Lawrence (KL) grades 0, 1, 2, and 3, respectively [49, 50] |
3. | Willingness to participate in exercise intervention and pharmacologic intervention |
4. | A maximum of 80 of 100 points in the KOOS Pain subscale (corresponding to, on average, at least mild pain) |
5. | BMI of less than 32 |
Exclusion criteria | |
General: | |
1. | Difficulty complying with treatment schedule |
2. | Inability to fill out questionnaires |
3. | Inability to ambulate without assistive device |
4. | Problems affecting the lower extremity overriding the problems from the knee |
5. | Physician-determined: |
6. | Any condition contraindicating use of acetaminophen, NSAIDs, or exercise |
7. | Already taking NSAIDs or acetaminophen at doses similar to or higher than the study dose |
8. | Diagnosis of systemic arthritis |
Radiographic: | |
1. | Medial greater than lateral joint-space width |
2. | Medial knee OA of KL grade 4 |
Previous and planned interventions: | |
1. | Previous ACL reconstruction or known ACL deficiency |
2. | Previous tibial osteotomy |
3. | Previous ankle, knee, or hip total joint replacement |
4. | Knee surgery including arthroscopy within the past 6 months |
5. | Steroid injection within the past 6 months |
6. | Knee surgery planned within the next 6 months |