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 |