Amputation Stumps, Pain
Conditions
Keywords
Lower limb amputation at least 6 months prior to inclusion, Presenting with moderate-to-severe pain intensity, Outpatients, aged 18 years and above
Brief summary
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.
Interventions
Cutaneous solution, 1 ml dose per 100 sq cm of affected skin area, To be applied twice daily for 28 days.
DRUGPlacebo
Cutaneous saline solution, 1 ml dose per 100 sq cm of affected skin area, To be applied twice daily for 28 days.
Sponsors
SantoSolve AS
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Lower limb amputation at least 6 months prior to inclusion * Presenting with moderate-to-severe pain intensity (above 50 on 100 mm VAS) at screening, to be confirmed prior to randomisation as: Mean (over the 14 days run-in period) stump API rating above 50 on a 100 mm VAS * Outpatients, aged 18 years and above * Written informed consent
Exclusion criteria
* Subjects who have received treatment with any potent opioid in the 4 weeks prior to study entry (i.e. an opioid assumed to cause abstinence symptoms upon abrupt cessation) * Subjects taking any analgesic medication (except for rescue medication as defined in this protocol) * Subjects with expressed dissatisfaction with their prosthesis comfort * Pregnant or breast-feeding women * Any malignant disease * Subjects who have received an investigational drug or used an investigational device in the 30 days prior to study entry. * Subjects unable to comply with the study assessments * Subjects with documented or suspected alcohol or drug abuse
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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). | 24 hours |
Secondary
| Measure | Time frame |
|---|---|
| • Pain relief | Weekly |
| • Sleep disturbance | 24 hours |
| • Use of rescue medication | Daily |
| • Patient Global Impression of Change (PGIC) | Weekly |
| • Worst Pain Intensity (WPI) | 24 hours |
| • Quality of life assessment | Q 14 days |
| Local skin irritability | Q 14 days |
| Adverse events | Q 14 days |
| • Prosthesis bothersomeness | Weekly |
Countries
Norway
Outcome results
None listed