Exercise therapy, manual therapy, or both, for osteoarthritis of the hip or knee: a factorial randomised controlled trial protocol

Table 1 Outcome measures

Primary Outcome measure*	Data collection instrument
WOMAC composite score	WOMAC-3.1 patient-rated questionnaire [30–32]
Secondary Outcome measures
Timed up-and-go	Physical test [38, 39]
30 second sit-to-stand	Physical test [37]
40 m self-paced walk	Physical test [32, 39]
WOMAC subscales: A) Pain; B) Stiffness C) Physical Function;	WOMAC-3.1 [33, 34] patient-rated questionnaire
Numeric pain rating	NPRS [33, 34] patient-rated questionnaire
Self-efficacy and pain beliefs	The Pain Belief Screening Instrument [40, 41]
Depression	The two-item case-finding instrument [42]
Patient's global assessment	GROC [33, 34, 36] patient-rated scale
OARSI response criteria	Composite of WOMAC, NPRS, GROC [34]
American College of Rheumatology criteria for diagnosis of OA	Clinician-rated criteria [22–24, 45, 46] from physical tests and symptoms
New Zealand National Clinical Priority System score	Clinician-rated criteria [47];
Adverse events	MOA field team audit; ODHB records; self-report questionnaire
Overall health status^†	SF-12 general health survey [43]
Surgical intervention^†	Self-report questionnaire; health system records [44]
Healthcare consumption and related costs^†	Self-report questionnaire; health system records

*The primary end-point for data analysis is 12 months. All outcome measures will be undertaken at baseline, 9 weeks, 6 months, 1 year and 2 years, with the exception of patients' global assessment and OARSI response criteria, which will not be assessed at baseline. ^†The primary endpoint for cost-utility and surgical intervention is at 2 years. WOMAC = Western Ontario and McMaster osteoarthritis index; NPRS = numeric pain rating scale; GROC = global rating of change; OA = Osteoarthritis; OARSI = Osteoarthritis Research Society International; MOA = the Management of OsteoArthritis Trial; ODHB = Otago District Health Board.