Research with human participants

Overview of medical research in the Netherlands

TIN FOIL FOR PREVENTION OF FANTOM LIMB PAIN AFTER A LOWER LEG AMPUTATION, CAUSED BY COMPLICATED VASCULAR DISEASE: a randomised cross-over study

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Last updated:

application of tin foil on an amputated leg deminishes fantoom pain

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Ethical review
Approved WMO
Status
Pending
Health condition type
Arteriosclerosis, stenosis, vascular insufficiency and necrosis
Study type
Interventional

ID

NL-OMON31254

Source

ToetsingOnline

Brief title

Tin foil and fantom pain

Condition

  • Arteriosclerosis, stenosis, vascular insufficiency and necrosis

Synonym

fantom pain, tin foil

Research involving

Human

Sponsors and support

Primary sponsor :
Onze Lieve Vrouwe Gasthuis
Source(s) of monetary or material Support :
vakgroep chirurgie

Intervention

Keyword :
aluminium, amputation, fantom pain, tin foil

Outcome measures

Primary outcome

fantom pain (VAS score)

Secondary outcome

wound pain (VAS score)

infection rate

Background summary

Their is anecdotical evidence that tin foil might decrease fantom pain after a
lower limp amputation.

Study objective

application of tin foil on an amputated leg deminishes fantoom pain

Study design

randomised cross over design

Intervention

tin foil on a amputation stump

Study burden and risks

no burden

Public
Onze Lieve Vrouwe Gasthuis

Postbus 95500
1090 HM Amsterdam
Nederland
Scientific
Onze Lieve Vrouwe Gasthuis

Postbus 95500
1090 HM Amsterdam
Nederland

Listed location countries

Netherlands

Age

Adults (18-64 years)
Elderly (65 years and older)

Inclusion criteria

- lower limb amputation (upper or lower leg)
- critical vascular disease
- informed consent
- primary closure of the wound

Exclusion criteria

- no primary closure of the wound (infection)

Design

Study phase :
3
Study type :
Interventional
Intervention model
:
Crossover
Allocation :
Randomized controlled trial
Masking :
Open (masking not used)
Control :
Placebo
Primary purpose :
Treatment

Recruitment

NL
Recruitment status
:
Pending
Start date (anticipated) :
Enrollment :
60
Type :
Anticipated

Approved WMO
Application type :
First submission
Review commission :
MEC-U: Medical Research Ethics Committees United (Nieuwegein)

Followed up by the following (possibly more current) registration

No registrations found.

Other (possibly less up-to-date) registrations in this register

No registrations found.

In other registers

Register ID
CCMO NL16655.067.07