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 |
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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
Exclusion criteria
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) |
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Interventions | Gabapentin ≤ 3600 mg
Amitriptyline ≤ 150 mg
Placebo (diphenhydramine ≤ 75 mg)
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Outcomes | Pain intensity Moderate pain relief Withdrawal |
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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 |