Abraham 2003.
Study characteristics | ||
Methods | Controlled clinical trial; DB followed by open phase, 3‐period, cross‐over; no wash‐out period; non‐involved doctor prepared drugs and order of administration Ff‐up after 10 days of each treatment period (DB phase) |
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Participants | Severe phantom pain for at least 1 month despite extensive pain therapy; majority of upper and lower extremity amputations of cancer aetiology, rest due to vascular and trauma; 10 participants, 5 males; mean age in yrs (SD): 50 (14); duration of phantom pain, months: 4.8 | |
Interventions |
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Outcomes | Number of participants with ≥ 50% pain relief on subjective pain intensity score 0 to 100; Feeling of well‐being from 0 to 100; Sedation score from 0 to 100; Adverse events; Dropouts/withdrawals |
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Notes | Limitations related to dosing and small sample size; n = 10 | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Not described |
Allocation concealment (selection bias) | Low risk | Physician not involved in study prepared batches of medications and order of administration |
Blinding (performance bias and detection bias) All outcomes | Low risk | Identical capsules; outcomes assessed at the medical centre acute pain service |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Outcomes assessed at the medical centre acute pain service but not clear if blinded |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Complete outcome data for all |
Selective reporting (reporting bias) | Unclear risk | Results in the DB phase reported in graphical form noting level of significance but without numerical results; the results for the specified outcomes in the methods section of the published study were reported, although not necessarily as our preferred outcomes |
Other bias | High risk | no wash‐out period; carry‐over effect not addressed |
Size of study | High risk | n = 10 |