Clinical trial NCT02589080: Phantom Limb Pain: Efficacy of Non-invasive Sensory Feedback Through the Prosthesis
Official title: Phantom Limb Pain: Efficacy of Non-invasive Sensory Feedback Through the Prosthesis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Phantom Limb Pain
Lead sponsor: Lund University Hospital
Sponsor class: OTHER
Collaborators: name: Aalborg University Hospital
name: University of Freiburg
name: Université Montpellier
name: Indiana University School of Medicine
name: Ecole Polytechnique Fédérale de Lausanne
name: Universitat Autonoma de Barcelona
name: Catholic University of the Sacred Heart
name: Aalborg University
First posted: 2015-10-28
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Amputation of a limb may result from trauma or surgical intervention. The amputation traumatically alters the body image, but often leaves sensations that refer to the missing body part. In 50-80% amputees, neuropathic pain develops, also called phantom limb pain (PLP). Both peripheral and central nervous system factors have been implicated as determinants of PLP. Also, PLP may be triggered by physical (changes in the weather) and psychological factors (emotional stress). Recent evidence suggests that PLP may be intricately related to neuroplastic changes in the cortex, and that these changes may modulated by providing sensory input to the stump or amputation zone.

A non-invasive clinical trial will test the effectiveness of non-invasive pressure sensory feedback build into a hand prosthesis to alleviate phantom limb pain.

Detailed description: During the pre-screen phase the investigators will assess whether the patient experiences referred phantom limb sensations or pain. In the case that the patient does experience referred sensations on the stump the investigators will map the areas where the sensation occurs on the stump and utilize this for placement of the surface actuators. In the opposite case, actuators will instead be placed in a matrix structure at the residual limb.

As a first step towards applying mechanical stimulation, the sensation thresholds (the level of stimulation where the subject first reports a sensation) have to be determined. The outcome of this procedure is a minimum of stimulation amplitude that can be applied for each stimulation site.

A first choice would be to use the referred map to place actuators. However, amputees have different phantom maps and also the number of areas varies.

A therapy will be defined based on the use of sensory feedback system integrated with the amputees hand prosthesis. The subject should use the hand prosthesis, with sensory feedback, for a duration of minimum 2 h per day during a 4 week period.

Preferably, the system should be used actively in normal daily activities.

Eligibility criteria: Inclusion Criteria:

* Transradial amputation
* Amputation should be in a stable phase
* Other treatments for PLP tried with poor result
* PLP experienced as over 6 on a visual analogue scale

Exclusion Criteria:

* Cognitive impairment
* Pregnancy
* History of active substance abuse disorder
* Acquired brain injury with residual impairment
* Intelligence disability
* Neurologic or musculoskeletal disease or other diseases that may affect the function of nervous system
* Pacemaker
* dermatologic condition

Primary outcomes:
measure: Change in phantom Limb pain
timeFrame: Baseline and after 4 week treatment
Secondary outcomes:
measure: Cortical reorganization
timeFrame: Baseline and after 4 week treatment (2 hours/day)
Other outcomes:
Locations:
city: Lund
country: Sweden
facility: Fredrik Sebelius
Study officials:
affiliation: Lund University
name: Fredrik Sebelius, PhD
role: PRINCIPAL_INVESTIGATOR
References: