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. 2016 Oct 13;2016(10):CD006380. doi: 10.1002/14651858.CD006380.pub3

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)
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
  1. s‐calcitonin at 200 IU, once, 20‐minute intravenous infusion 

  2. saline

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
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