Pilowsky 1990.
Study characteristics | ||
Methods | Design: parallel Duration: 12 weeks Assessment: baseline and post‐intervention Country: Australia |
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Participants | Pain condition: chronic, intractable 'psychogenic' pain Population: patients with chronic, intractable ‘psychogenic’ pain Minimum pain intensity: no Inclusion criteria
Exclusion criteria
Total participants randomised: 129 Age in years (mean): 42.26 Gender: 80/129 were female Pain duration in years (mean, SD): NR |
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Interventions | Amitriptyline + pyschotherapy
Amitriptyline + support
Placebo + psychotherapy
Placebo + support
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Outcomes | Pain intensity Withdrawal |
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Missing data methods | Completer analysis | |
Funding source | Non‐pharmaceutical: "We are indebted to the National Health and Medical Research Council who provided generous support for the conduct of this study." | |
Conflicts of interest | NR | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Participants were randomised to 1 of 4 treatment groups with the use of a table of random numbers. |
Allocation concealment (selection bias) | Unclear risk | Allocation procedure not specified |
Blinding of participants and personnel (performance bias) All outcomes | High risk | No mention of blinding procedures between psychotherapy/support and amitriptyline/placebo. |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Very different intervention experience for those undergoing psychotherapy versus simple support. Triallists attempt to control for effects of contact in therapy by having clincian support, but participants would be aware of their intervention |
Incomplete outcome data (attrition bias) All outcomes | High risk | Completer analysis only. Original numbers of participants in arms not given, and withdrawal only given in percentages. No reasons given for withdrawal Attrition Total: 28/129 (21.7%) Amitriptyline ≤ 150 mg + psychotherapy: 6/26 (24%) Amitriptyline ≤ 150 mg + support: 7/26 (25%) Psychotherapy: 5/26 (19%) Support: 7/24 (31%) |
Selective reporting (reporting bias) | High risk | Some outcome measures mentioned in the methods don't seem to be reported in the results section (e.g. McGill pain questionnaire). No protocol or trial registration found |
Other bias | Low risk | No other sources of bias were identified. |