Aluminium foil for the prevention of post-amputation pain: a randomised, double-blinded, placebo-controlled, crossover trial
Introduction:
Phantom limb pain (PLP) is a painful sensation perceived in the missing limb after amputation. The underlying pathophysiology remains unclear. Until recently, only opioid analgesics have been proven to be effective in prospective studies. Anecdotally, patients with PLP employ self-help measures, sometimes including ‘wrapping up’ or rubbing their stump with aluminium foil for relief. Our hypothesis is that wrapping an amputation stump with aluminium foil perioperatively will prevent PLP in the postoperative period.
Methods:
From September 2007 to September 2009, 32 consecutive patients were included in a crossover, double-blinded, randomised clinical trial. Perioperative fitting of an aluminium stump bandage was compared with a placebo paper foil. Scores were noted daily in a variable diary. The observation period was 2 weeks: in the first week participants were double blinded, and in the second week there was a change of bandage from aluminium to placebo or vice versa. A visual analogue scale (VAS) score was used as primary research variable. Secondary variables were use of analgesics, VAS measures of wound pain and the incidence of wound infections. Statistical analysis was done by means of Student’s t-test for non-paired observations.
Results:
Baseline characteristics were similar between groups. A period effect ( p= 0.84) and treatment–period interaction ( p = 0.79) were not present. There was no significant difference (mean difference 0.42) between both treatments in PLP VAS scores (95% CI −2.56 to −1.81, p = 0.71). VAS measure of wound pain showed no significant difference between both groups (mean difference 0.34, 95% CI −2.32 to −1.66, p = 0.72). Also, the other secondary endpoints did not differ.
Conclusion:
Patients receiving an aluminium foil stump wrapping do not experience less phantom pain than with a placebo.
