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. 2023 May 10;2023(5):CD014682. doi: 10.1002/14651858.CD014682.pub2

Goldman 2010.

Study characteristics
Methods Design: parallel
Duration: 6 weeks
Assessment: baseline and post‐intervention
Country: USA
Participants Pain condition: arm pain
Population: people with persistent arm pain from repetitive use
Minimum pain intensity: ≥ 3 on 0‐10 VAS
Inclusion criteria
  • Adults with persistent arm pain that had lasted for at least 3 weeks

  • ≥ 3 on 0‐10 pain intensity VAS


Exclusion criteria
  • Physical health conditions that may affect arm pain


Total participants randomised: 118
Age in years (mean): 37.5
Gender: 66/118 were female
Pain duration in years (mean, SD): NR
Interventions Placebo
  • n = 59

  • Inert

  • Identical appearance to antidepressant arm

  • Matched dosing


Amitriptyline 25 mg
  • n = 59

  • TCA

  • Fixed dose

  • If participants complained of side effects during the study, the physician could reduce the dose by half or more

Outcomes Pain intensity
Sleep
Mood
AEs
SAEs
Withdrawal
Missing data methods ITT with LOCF
Funding source Non‐pharmaceutical: "This study was supported by Grants 1RO1 AT 00402‐01 and 1K24 AT 004095 from the National Center for Complementary and Alternative Medicine (NCCAM) at the National Institutes of Health, USA"
Conflicts of interest "No author had or now has any financial interest in any for‐profit organisation related to the treatment of patients with repetitive strain injuries or related disabling conditions. Dr Rose Goldman sometimes serves as a paid expert witness, independent medical examiner, and/or consultant in workers' compensation and disability cases that might involve musculoskeletal problems and repetitive strain injuries."
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Participants were randomised using a permuted block randomisation design
Allocation concealment (selection bias) Low risk Participants were allocated using assignments sealed in sequentially numbered opaque envelopes
Blinding of participants and personnel (performance bias)
All outcomes Low risk Double‐blind, identical study drugs and matched dosing
Blinding of outcome assessment (detection bias)
All outcomes Low risk Self‐reported outcomes from blinded participants
Incomplete outcome data (attrition bias)
All outcomes Low risk ITT with LOCF but low attrition
Attrition
Total: 12/118 (10.2%)
Placebo: 4/59 (6.8%)
Amitriptyline 25 mg: 8/59 (13.6%)
Selective reporting (reporting bias) Unclear risk No protocol or trial registration found
Other bias Low risk No other sources of bias were identified.