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

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.

Conditions

• Phantom Limb Pain

Interventions

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.

Sponsors & Collaborators

• Aalborg University Hospital

  collaborator OTHER

• University of Freiburg

  collaborator OTHER

• Université Montpellier

  collaborator OTHER

• Indiana University School of Medicine

  collaborator OTHER

• Ecole Polytechnique Fédérale de Lausanne

  collaborator OTHER

• Universitat Autonoma de Barcelona

  collaborator OTHER

• Catholic University of the Sacred Heart

  collaborator OTHER

• Aalborg University

  collaborator OTHER

• Lund University Hospital

  lead OTHER

Principal Investigators

• Fredrik Sebelius, PhD · Lund University

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2015-01-31

Primary Completion

2017-08-31

Completion

2017-08-31

Countries

• Sweden

Study Locations