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

Alcoff 1982.

Study characteristics
Methods Design: parallel
Duration: 8 weeks
Assessment: baseline and post‐intervention (8 weeks)
Country: USA
Participants Pain condition: low back pain
Population: adults with chronic low back pain
Inclusion criteria

  • Low back pain for at least 6 weeks if first episode, or ≥ 2 prior episodes lasting at least 2 weeks with a current episode of a minimum of 2 weeks' duration


Exclusion criteria
NR, but the following potential participants were excluded:

  • 1 person had a persistent diastolic blood pressure reading of > 90 mm Hg

  • 1 person had ECG changes consistent with an old myocardial infarction


Total participants randomised: 50
Age in years (mean, SD): NR
Gender: 24/50 were female
Pain duration (categorical): < 2 years (n = 8), 2–4 years (n = 6), > 4 years (n = 14)
Interventions Imipramine

  • 28 participants

  • Fixed dose of 150 mg/day


Placebo

  • 22 participants

  • Identical appearance and dosing to imipramine
Outcomes Withdrawal
Missing data methods NR
Funding source Non‐pharmaceutical: the Bureau of Medicine and Surgery, Department of the Navy, Clinical Investigation Pro­gram, USA
Conflicts of interest NR
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Not enough information ‐ just says 'randomly assigned'
Allocation concealment (selection bias) Unclear risk Only the pharmacist knew the treatment allocation, but unclear how this was allocated
Blinding of participants and personnel (performance bias)
All outcomes Low risk Double‐blind, placebo was identical in appearance
Blinding of outcome assessment (detection bias)
All outcomes Low risk Self‐reported outcomes by blinded participants
Incomplete outcome data (attrition bias)
All outcomes High risk Missing data methods NR and unequal attrition between arms
Attrition:
Total: 9/50 (18.0%)
Placebo attrition: 2/22 (9.1%)
Imipramine 150 mg: 7/28 (25.0%)
Selective reporting (reporting bias) Unclear risk No protocol or trial registration found
Other bias Low risk No other sources of bias identified