Predicting Central Pain Among People With a Spinal Cord Injury by Evaluating Mechanisms Regulating Pain and Efficacy Testing of the TENS Apparatus

Summary

People with a Spinal Cord Injury can develop chronic pain within months of the injury. Up to 80% of the patients will develop chronic pain called "central pain" and describe the pain as: burning, stabbing, or "like electricity." Central pain mechanism is unknown and therefore treatment is currently not effective.

It is hypothesized that chronic pain is associated with impaired function of the systems regulating pain, however, this hypothesis has not been tested among Spinal Cord Injury patients. Presence of such a connection, between the regulating system dysfunction and central pain, will help both predicting the risk of central pain and develop a treatment.

The current research objective is to make several sensory measurements which will measure the functioning mechanisms of regulation and control of the pain. These measurements are accepted throughout the world and are based on psychophysical assessment of patients. these Measurements are designed to assess whether Spinal Cord Injury chronic central pain patients demonstrate impairment in the regulation of pain. Finding such a link between central pain and impaired regulation could shed light on the mechanism of central pain. In addition, these measurements are designed to assess whether fresh spinal cord injury patients that have not yet developed central pain demonstrate impairment in the regulation of pain immediately after the injury. By repeated assessments of pain regulation capabilities, which will be made to fresh Spinal Cord Injury patients during the first months of injury, and comparing the results of these measurements between those who will develop center pain and those who will not, we could identify indicators for predicting the risk of central pain. Another goal of the study is to investigate the efficacy of central pain treatment, using a TENS, when the parameters of the TENS treatment will be built according to the level of functioning of the regulating systems of the individual.

Conditions

• Pain
• Healthy

Interventions

DEVICE

Thermal stimulation

Stimulation using a Thermal Sensory Analyzer: 2001, Maddock ltd., Israel.

DEVICE

Mechanical stimulation

Stimulation using Semmes-Weinstein-Monofilament Touch Test Sensory Evaluators

DEVICE

Transcutaneous Electrical Nerve Stimulator (TENS)

A portable stimulator designed to Physical treatment of pain. TENS - Cedar rehab X2. Chattanooga group.USA.

Sponsors & Collaborators

• Sheba Medical Center

  lead OTHER_GOV

Principal Investigators

• Gabriel Zeilig, MD · Sheba Hospital

Study Design

Allocation

NON_RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2012-12-31

Primary Completion

2019-08-31

Completion

2019-08-31

Countries

• Israel

Study Locations