The objective of this study is to investigate the analgesic effect of topical strontium chloride in stump pain, and to prospectively determine other efficacy and safety measures of topical strontium chloride in stump pain.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
22
Cutaneous solution, 1 ml dose per 100 sq cm of affected skin area, To be applied twice daily for 28 days.
Cutaneous saline solution, 1 ml dose per 100 sq cm of affected skin area, To be applied twice daily for 28 days.
Smerud Investigator site 1
Oslo, Norway
Average Pain Intensity (API): will be measured each evening in response to the question: 'What was your average pain intensity over the past 24 hours?' on a 100 mm VAS (0 = no pain, 100 = worst pain imaginable).
Time frame: 24 hours
• Worst Pain Intensity (WPI)
Time frame: 24 hours
• Pain relief
Time frame: Weekly
• Sleep disturbance
Time frame: 24 hours
• Use of rescue medication
Time frame: Daily
• Patient Global Impression of Change (PGIC)
Time frame: Weekly
• Prosthesis bothersomeness
Time frame: Weekly
• Quality of life assessment
Time frame: Q 14 days
Local skin irritability
Time frame: Q 14 days
Adverse events
Time frame: Q 14 days
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