Jaeger 1992.
Study characteristics | ||
Methods | Controlled clinical trial, cross‐over; 2‐hour wash‐out period; double‐blind phase, then an open phase with the intervention (s‐calcitonin) for longer‐term assessment; drawing of lots by person not involved in study Ff‐up: short‐term: 24 hrs before and after treatment (double‐blind); long‐term: 6 mos, 1 to 2 yrs (open phase) |
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Participants | Phantom pain 0 to 7 days following amputation; all except one are lower limb amputations of vascular, traumatic, malignancy, and infectious aetiology, at least 3 on 0‐to‐10 numerical analogue scale; 21 participants, 12 males; median age yrs (range): 59 (20 to 78) | |
Interventions |
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Outcomes | Change in pain intensity on 0‐to‐10 numerical analogue scale; Number of participants with pain reduction of > 50%; Long term (at 1 yr): number of participants with reduction of > 75%; Adverse events; Dropouts/withdrawals; Other outcomes: number of phantom pain attacks, number of participants requiring second infusion for phantom pain recurrence |
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Notes | n = 21 | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | "patients with PLP exceeding 3 on NAS were randomly divided into 2 groups" |
Allocation concealment (selection bias) | Unclear risk | Not described |
Blinding (performance bias and detection bias) All outcomes | Low risk | "double‐blind" |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not described |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Some missing data, as some participants did not have the second infusion, placebo, as their NAS did not exceed 3 |
Selective reporting (reporting bias) | Unclear risk | Numerical results for pain intensity on NAS not reported, although out in graphical form and noted significance; all specified outcomes in methods were reported, although not necessarily our preferred outcomes |
Other bias | Unclear risk | Unclear if baseline pain characteristics were not significantly different in treatment and placebo interventions |
Size of study | High risk | n = 21 |