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. 2013 Dec 12;2013(12):CD008742. doi: 10.1002/14651858.CD008742.pub2

Goldman 2010.

Methods RCT; randomisation by uninvolved assistant using envelopes; double‐blind, placebo‐controlled
Participants Adults with upper extremity pain due to repetitive use or prolonged static postures; n = 118
Interventions Amitriptyline (25 mg): n = 59
Placebo pill: n = 59
Treatment: six weeks, follow‐up at 10 weeks 
Outcomes Pain intensity (NRS), Levine Symptom Severity Scale (0 to 55), Upper Extremity Function Scale (8 to 88) 
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk A permuted block randomisation with variable block sizes and assignments sealed in sequentially numbered opaque envelopes
Allocation concealment (selection bias) Low risk "Person performing randomization .. was at a separate site .. and had nothing to do with the study participants or collection of data" 
Blinding of participants? Low risk Participant blinded
Blinding of caregivers? Low risk Caregivers blinded
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk "Research assistants involved in data collection were also blinded to treatment assignment"; participant blinded for participant‐reported outcomes
Incomplete outcome data (attrition bias) 
 All outcomes ‐ <20% drop‐outs? Low risk 51/59 amitriptyline and 55/59 placebo returned for post‐treatment assessment. < 20% dropouts
Incomplete outcome data (attrition bias) 
 All outcomes ‐ ITT analysis performed? Low risk Table 4: ITT analysis—imputed missing values
Selective reporting (reporting bias) Unclear risk No protocol
Similarity of baseline characteristics? Low risk  "Well balanced on all variables (Table 1); no clinically significant differences"
Co‐interventions avoided? Low risk Placebo versus active pill but no mention of advising participants to refrain from co‐interventions
Compliance acceptable ? Low risk Adherence:  "... figures at the end of treatment were 87% and 89% ..."
Timing outcome assessment comparable? Low risk Timing comparable