Mechanisms and Treatment of Post-amputation Neuropathic Pain

Last updated on July 2021

Recruitment

Recruitment Status: Not yet recruiting
Estimated Enrollment: Same as current

Summary

Conditions

Amputation
Neuropathic Pain
Phantom Limb Pain

Type

Interventional

Phase

Not Applicable

Design

Allocation: RandomizedIntervention Model: Crossover AssignmentIntervention Model Description: All included patients participate in sub-study 1 and 2. Sub-study 1 is an observational study where patients undergo a spinal anaesthesia in an open label manner. In sub-study 2, patients are once randomly assigned in a 1:1 ratio to one of two counterbalanced arms: either they first receive active rTMS, and then after a 9 week washout period, sham rTMS, or they first receive sham rTMS, and then after 9 weeks of washout, active rTMS. Thus, patients undergo stimulation with deep rTMS in a double blinded randomised controlled trial with a 2 x 2 cross-over design, receiving both active and placebo stimulationMasking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)Masking Description: Blinding is achieved by inserting a card into the rTMS stimulator which determines whether the patients receive active or sham stimulation. Thus, both experimenter and patients are blinded towards group allocation. Care providers are also blinded to the treatment allocation. The main efficacy analyses will be performed blinded without identification of participants and group allocation.Primary Purpose: Treatment

Participation Requirements

Age: Between 18 years and 80 years
Gender: Both males and females

Description

Not Provided

Tracking Information

NCT #: NCT04819503
Collaborators: Not Provided
Investigators: Study Director: Audun Stubhaug, DMedSci Oslo University Hospital