Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:07 PM
Ignite Modification Date:
2025-12-24 @ 11:07 PM
NCT ID:
NCT01714869
Eligibility Criteria:
Inclusion Criteria:
1. Be a veteran enrolled in care at the Durham VA Medical Center.
2. 35 years of age or greater.
3. Written confirmation of OA of the knee as provided by the participant's physician.
4. Radiographically-established OA of the knee.
5. Pre-randomization score in a specified range on the Visual Analog Pain Scale (0 - 100 mm scale).
6. Receiving care for diagnosed OA of the knee under the care of a board-certified primary care physician, with or without involvement of a board-certified rheumatologist.
7. Patients with bilateral knee involvement will have the more severely affected knee designated as the study knee.
8. American College of Rheumatology defined OA of the knee; specifically:
a. Knee pain b. Satisfaction of at least three of the following six criteria: i. Age greater than 50 years ii. Stiffness \< 30 minutes iii. Crepitus iv. Bony Tenderness v. Bony enlargement vi. No palpable warmth
Exclusion Criteria:
1. Presence of rheumatoid arthritis, fibromyalgia, recurrent or active pseudo gout.
2. Presence of cancer or other decompensated medical conditions that limit the ability to participate fully in all interventions, assessments, and follow-up visits.
3. Signs or history of kidney or liver failure.
4. Presence of asthma requiring the use of corticosteroid treatment.
5. Use of oral corticosteroids within the past four weeks.
6. Use of intra-articular knee depo-corticosteroids with the past three months.
7. Use of intra-articular hyaluronate with the past six months.
8. Arthroscopic surgery of the knee within the past year.
9. Significant injury to the knee within the past six months.
10. Presence of a rash or open wound over the knee.
11. Unable to satisfy the treatment and follow-up requirements.
12. Unable to provide written informed consent.
13. Currently receiving massage therapy on a regular basis (at least twice a month).
14. Knee replacement of study knee (ok if the knee not being studied has been replaced).
15. History of participating in the EMBARK Phase I (2004) or II (2009) studies.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
35 Years
Study:
NCT01714869
Study Brief:
Protocol Section:
NCT01714869