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Table 1 Schedule of study flow and assessments

From: Effect of low-dose amitriptyline on reducing pain in clinical knee osteoarthritis compared to benztropine: study protocol of a randomised, double blind, placebo-controlled trial

  Enrolment Baseline 2 weeks 6 weeks 12 weeks
ENROLMENT:
 Eligibility screen x     
 Informed consent x     
 Clinical assessment   x    
 Randomisation   x    
INTERVENTION:
 Amitriptyline, 25 mg nocte   Alternate Nightly Nightly Nightly
 Benztropine, 1 mg, nocte   Alternate Nightly Nightly Nightly
ASSESSMENTS
Primary and secondary outcomes
  WOMAC (pain, stiffness, function, total)   x    x
Other measures of knee pain
  Pain severity (NRS, 0–10)   x x x x
  Pain severity (VAS, 100 mm), pain diagram   x    x
  PainDETECT   x    x
Functional status and severity
  ACR functional class I, II or III   x    x
  Investigator assessed global assessment of OA status (Likert, 0 very well–4 very poor)   x    x
  General health status (AQOL-8D)   x    x
  Leg muscle strength (in triplicate)   x    x
  Xray – KL score, osteophytes, JSN   x    
Other measures of response
  Pain acceptability (48 h)   x    x
  Patient global impression of change (Likert, 0–7)    x x x
Other measures
  Inclusion criteria: pain & 1 of age > 50, stiff <30mins, Crepitus, osteophytes and KOA   x    
  Age, height, weight, bp, smoking   x    
  Medical conditions   x    x
  Education (category), Employment current status, type of work (manual, office, NA)   x    
  Medications – analgesics, NSAID, opioid   x    x
  Fear of movement (TSK)   x    x
  Mood disorder (HADS)   x    x
  Physical activity (IPAQ, 7 days)   x    x
  Sleep quality and disturbance (PSQI)   x    x
Treatment and safety issues
  Medications – analgesics, NSAID, opioid   x    x
  Treatment belief: study drug or placebo      x
  Rating of medication and side effects (Scale, excellent, good, fair, poor, unacceptable)      x
  UKU   x x x x
  Adverse events    x x x
  Adherence, pill count      x
  1. WOMAC Western Ontario and McMaster Arthritis Index. NRS Numerical rating scale VAS visual analogue scale, AQOL-8D Assessment of quality of life. TSK Tampa Scale of Kinesiophobia HADS Hospital anxiety and depression scale IPAQ International physical activity questionnaire PSQI Pittsburgh sleep quality index UKU: UKU Side effect rating scale for psychotropic drugs