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

Rintala 2007.

Study characteristics
Methods Design: cross‐over
Duration: each cross‐over period was 8 weeks
Assessment: baseline and post‐cross‐over period
Country: USA
Participants Pain condition: chronic neuropathic pain following spinal cord injury
Population: adults with a spinal cord injury at least 12 months ago with chronic neuropathic pain
Minimum pain intensity: ≥ 5 on 0‐10 scale
Inclusion criteria
  • Aged 18‐70

  • Spinal cord injury occurred at least 12 months before entering the study

  • At least 1 chronic (6 months) pain component characteristic of neuropathic pain

  • At least 1 neuropathic pain component rated as at least 5 on a 0‐10 scale


Exclusion criteria
  • Physical and mental health comorbidities


Total participants randomised: 38
Age in years (completers; mean, SD): 42.6 (12.6)
Gender (completers): 2/38 were female
Pain duration in years (completers; mean, SD): 7.3 (7.7)
Interventions Gabapentin ≤ 3600 mg
  • Anticonvulsant

  • Forced titration to maximum tolerated dose

  • Matched dosing schedule


Amitriptyline ≤ 150 mg
  • TCA

  • Forced titration to maximum tolerated dose

  • Matched dosing schedule


Placebo (diphenhydramine ≤ 75 mg)
  • Active placebo ‐ antihistamine

  • Forced titration to fixed dose

  • Matched dosing schedule

Outcomes Pain intensity
Moderate pain relief
Withdrawal
Missing data methods Completer‐only analysis
Funding source Non‐pharmaceutical: supported by the Department of Veterans Affairs, Veterans Health Administration, Rehabilitation Research and Development Service (grant no. B2573R)
Conflicts of interest "No commercial party having a direct financial interest in the results of the research supporting this article has or will confer a benefit upon the author(s) or upon any organisation with which the author(s) is/are associated"
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk The order of this assignment within the sets of 6 was based on a table of random numbers, and varied from set to set.
Allocation concealment (selection bias) Unclear risk Allocation procedure not specified
Blinding of participants and personnel (performance bias)
All outcomes Low risk Matched dosing regime, active comparator used as placebo, and identical capsules for medication
Blinding of outcome assessment (detection bias)
All outcomes Low risk Self‐reported outcomes from blinded participants
Incomplete outcome data (attrition bias)
All outcomes High risk Completer analysis only. High levels of attrition
Attrition
Total: 16/38 (42.1%)
Gabapentin ≤ 3600 mg: 12/38 (31.6%)
Amitriptyline ≤ 150 mg: 10/38 (26.3%)
Placebo: 13/38 (34.2%)
As this is a cross‐over study, some participants only withdrew from one period of the study, not the study as a whole, therefore, the numbers of participants withdrawing per arm does not match the total numbers of participants withdrawing.
Selective reporting (reporting bias) Unclear risk No protocol or trial registration found
Other bias Low risk No other sources of bias identified