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

Pilowsky 1990.

Study characteristics
Methods Design: parallel
Duration: 12 weeks
Assessment: baseline and post‐intervention
Country: Australia
Participants Pain condition: chronic, intractable 'psychogenic' pain
Population: patients with chronic, intractable ‘psychogenic’ pain
Minimum pain intensity: no
Inclusion criteria
  • Complaint of pain for at least 1 month, which is not responding adequately to appropriate treatment

  • Absence of objective evidence for the presence of any significant organic disease sufficient to explain the presence or severity of the pain experience and degree of disability

  • Impairment of functioning by at least 25% taking into account biological, personal, social, occupational and recreational aspects


Exclusion criteria
  • Physical and mental health comorbidities


Total participants randomised: 129
Age in years (mean): 42.26
Gender: 80/129 were female
Pain duration in years (mean, SD): NR
Interventions Amitriptyline + pyschotherapy
  • n = 26

  • Combined intervention: TCA + psychotherapy

  • Amitriptyline: flexibly dosed up to 150 mg/day

  • Psychotherapy: 12 weekly, 45‐minute psychotherapy sessions focusing on "facing inner conflicts" that were theorised to be causing physical pain


Amitriptyline + support
  • n = 26

  • TCA

  • Amitriptyline: flexibly dosed up to 150 mg/day

  • Support to 'match' psychotherapy: 6 x 2‐weekly. 15‐minute sessions that focused on the physical symptoms, effects and side effects of medication


Placebo + psychotherapy
  • n = 26

  • Inert placebo

  • Psychotherapy: 12 weekly, 45‐minute psychotherapy sessions focusing on "facing inner conflicts" that were theorised to be causing physical pain


Placebo + support
  • n = 24

  • Inert placebo

  • Support to 'match' psychotherapy: 6 x 2‐weekly, 15‐minute sessions that focused on the physical symptoms, effects and side effects of medication

Outcomes Pain intensity
Withdrawal
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.