Phantom Limb Pain: Efficacy of Non-invasive Sensory Feedback Through the Prosthesis (EPIONE)

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.

Study Overview

• Status: Completed
• Conditions: Phantom Limb Pain
• Intervention / Treatment: Behavioral: Non-invasive sensory feedback

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.

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Lund, Sweden, SE-22100
    • Fredrik Sebelius

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Non-invasive sensory feedback

Behavioral: Non-invasive sensory feedback; A non-invasive simple sensory feedback system, which provides the user of a prosthetic hand with sensory feedback on the arm stump. It is mediated by air in a closed loop system connecting silicone pads on the prosthetic hand with pads on the amputation stump. The silicone pads in a "tactile display" on the amputation stump expand when their corresponding sensor-bulb in the prosthesis is touched, evoking an experience of "real touch". Most amputees experience phantom limb sensations and/or phantom limb pain, as well as residual limb stump pain. There is often a "map" of the phantom hand on the amputation stump, where pressure on specific skin areas result in evoked sensation from specific fingers in the amputated phantom hand. This map is the target for the sensory feedback.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in phantom Limb pain	Baseline status includes: phantom limb pain assessed using visual analogue scale.	Baseline and after 4 week treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cortical reorganization	MRI: Change in cortical response during sensory stimulation is examined	Baseline and after 4 week treatment (2 hours/day)

Collaborators and Investigators

• Sponsor: Lund University Hospital
• Collaborators: Catholic University of the Sacred Heart; Universitat Autonoma de Barcelona; Aalborg University Hospital; Aalborg University; Université Montpellier; Indiana University School of Medicine; Ecole Polytechnique Fédérale de Lausanne; University of Freiburg
• Investigators: Principal Investigator: Fredrik Sebelius, PhD, Lund University

Study record dates

Study Major Dates

• Study Start: January 1, 2015
• Primary Completion (Actual): August 1, 2017
• Study Completion (Actual): August 1, 2017

Study Registration Dates

• First Submitted: October 11, 2015
• First Submitted That Met QC Criteria: October 26, 2015
• First Posted (Estimate): October 28, 2015

Study Record Updates

• Last Update Posted (Actual): August 17, 2018
• Last Update Submitted That Met QC Criteria: August 15, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Postoperative Complications; Pain; Neurologic Manifestations; Neurobehavioral Manifestations; Perceptual Disorders; Pain, Postoperative; Phantom Limb
• Other Study ID Numbers: EPIONE-LU