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Calcitonin Prophylaxis in Phantom Limb Pain - Calcitonin Prophylaxis in Phantom Limb Pai

Conditions
Almost 60% of patients suffer from phantom limb pain one year after surgery, whereas in the first month, 85% to 97% of patients experience phantom limb pain. IV. calcitonin in the early postoperative period was effective in phantom limb pain in one single double-blind, crossover study. Because of the lack of any confirmatory observation we are testing the hypothesis that calcitonin is effective in phantom limb pain prophylaxis.
MedDRA version: 9.1Level: LLTClassification code 10034804Term: Phantom limb pain
Registration Number
EUCTR2008-005470-12-AT
Lead Sponsor
Medical University of Vienna
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
ot Recruiting
Sex
All
Target Recruitment
Not specified
Inclusion Criteria

patients undergoing elective amputation on the lower extremity
age between 18 and 70 years
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

contraindication to calcitonin, age < 18 yr,
patients undergoing further amputation during the follow up period
hypocalcemia

Study & Design

Study Type
Interventional clinical trial of medicinal product
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Main Objective: occurrence of phantom limb pain on the 28th day postoperatively;Secondary Objective: occurrence of phantom limb pain on day 1, 4, 7 and after 3 months, consumption of the anti-neuropathic medication and morphine during the postoperative period.;Primary end point(s): Phantom limb pain on day 28 after surgery
Secondary Outcome Measures
NameTimeMethod
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