Background
Methods
Aim
Study Design
Hypothesis
Ethical Issues
Subjects
Inclusion criteria | Exclusion criteria |
---|---|
English speaking | Co-existing inflammatory arthritis |
Aged 18 years or over | Serious co-morbidity |
Diagnosis of OA (X-Ray or clinical Dx) | Scheduled knee replacement in < 6 months |
Referral from GP or Specialist | Cannot meet program time-points |
Able to meet program requirements |
Group allocation
Intervention
-
Pain management strategies (cognitive and pharmaceutical)
-
Joint protection
-
Fitness/exercise
-
Correct use of analgesia/medications
-
Balance/falls prevention/proprioception
-
Cognitive techniques
-
Pathophysiology
-
Nutrition/weight control
-
Self-management skills
-
Team approach to health care
-
SMART goals (S pecific, M easurable, A chievable, R ealistic, T ime-framed)
Assessments and Procedures
Primary outcomes
-
Health status; measured using the WOMAC Osteoarthritis Index for OA of the knee (WOMAC LK3.0). Also self-administered, the WOMAC assesses pain, stiffness and physical function [13] and can be completed in less than 5 minutes. Two major studies have shown WOMAC pain, stiffness and physical function subscales are valid and the questionnaire is reliable and sensitive enough to detect changes in health status following a variety of interventions [14, 15]
-
Quality of life; measured using the Short Form 36v1 (SF-36) questionnaire. This 36 item questionnaire is self administered, and can be completed in about 15 minutes [16]. Scores for 8 sub components reflecting both physical and mental status can be generated. Reliability and validity have been established in numerous studies [16, 17].
Secondary outcomes
-
Strength of the hamstrings and quadriceps muscles will be measured using a Mecmesin Force Gauge Dynamometer. The dynamometer will be fixed via an adjustable arm to a portable steel frame and stool. Subjects will sit on the stool with hips and knees flexed to 90 degrees. Isometric strength in flexion and extension will be measured in this position. Each knee will be measured 3 times. The first measurement will be a practice and will be excluded from analysis. The two subsequent measures will be averaged for analysis.
-
Pain will be assessed at weekly intervals from baseline to the 8-week follow-up assessment. (See Figure 1: Study Design Flow Chart). A 10 cm Visual Analog Scale (VAS) anchored at the left with "no pain" and at the right "worst pain imaginable" will be used for this assessment. The VAS is well established in clinical practice and research for measuring pain levels in arthritis populations [20].
-
Functional mobility, using a Functional Knee Assessment Test (FKAT) will be assessed using a modification of the "Timed Up and Go" test (TUG). TUG is widely used to assess basic functional mobility in the elderly [21‐23]. The test measures the time taken to stand from a chair and walk 6 m, turn around, return to the chair and sit down. For this study the addition of ascending and descending a 15 cm step will be added to the outward walk.