NCT01726881

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P75+ for not_applicable pain

Timeline
Completed

Started Dec 2012

Longer than P75 for not_applicable pain

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 8, 2012

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 15, 2012

Completed
16 days until next milestone

Study Start

First participant enrolled

December 1, 2012

Completed
6.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2019

Completed
Last Updated

August 28, 2018

Status Verified

August 1, 2018

Enrollment Period

6.7 years

First QC Date

November 8, 2012

Last Update Submit

August 27, 2018

Conditions

PainHealthy

Keywords

chronicSpinal Cord Injury patients

Outcome Measures

Primary Outcomes (4)

  • Sensitivity to thermic pain

    Minimum temperature at which the patient reported pain. The subject will press a button once feeling pain. pain will be reported using a visual analog scale - a pain scale between 1-10.

    5 minutes

  • Pain suppression capability

    Reduction of pain in the presence of another stimulus. pain will be reported using a visual analog scale - a pain scale between 1-10.

    5 minutes

  • Habituation to tonic stimulation

    Gradient decrease in pain rating. pain will be reported using a visual analog scale - a pain scale between 1-10.

    5 minutes

  • Temporal summation of pain

    Standard rating of pain among several stimuli. pain will be reported using a visual analog scale - a pain scale between 1-10.

    5 minutes

Study Arms (3)

Fresh Spinal Cord Injury patients

EXPERIMENTAL

Spinal Cord Injury patients that are currently admitted to the rehabilitation unit with three weeks or less since injury that will over go several tests and will fill out several questionnaires.

Device: Thermal stimulationDevice: Mechanical stimulation

Chronic Spinal Cord Injury patients

EXPERIMENTAL

Spinal Cord Injury patients with one year or more since injury that will over go several tests and will fill out several questionnaires

Device: Thermal stimulationDevice: Mechanical stimulationDevice: Transcutaneous Electrical Nerve Stimulator (TENS)

Healthy volunteers

ACTIVE COMPARATOR

Healthy subjects that will over go several tests and will fill out several questionnaires

Device: Thermal stimulationDevice: Mechanical stimulation

Interventions

Thermal stimulationDEVICE

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

Chronic Spinal Cord Injury patientsFresh Spinal Cord Injury patientsHealthy volunteers
Mechanical stimulationDEVICE

Stimulation using Semmes-Weinstein-Monofilament Touch Test Sensory Evaluators

Chronic Spinal Cord Injury patientsFresh Spinal Cord Injury patientsHealthy volunteers
Transcutaneous Electrical Nerve Stimulator (TENS)DEVICE

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

Chronic Spinal Cord Injury patients

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • for all subjects:
  • age - 18-70
  • Cognitive status that allows voluntary cooperation understanding of instruction
  • for chronic Spinal Cord Injury subjects:
  • spinal cord injury (complete and incomplete)
  • height of injury - under 7th cervical vertebra
  • time since injury - one year or more.
  • for chronic Spinal Cord Injury subjects:
  • spinal cord injury (complete and incomplete)
  • height of injury - under under 7th cervical vertebra
  • time since injury - three weeks or less

You may not qualify if:

  • subjects suffering from the following conditions: pacemaker,pregnancy,cancer, tuberculosis, thrombosis, metallic implants
  • systemic diseases that affect the sensory perception (such as diabetes)
  • patients with other neurological pathologies (such as head injury-TBI)
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sheba Medical Center rehabilitaion facility

Ramat Gan, Israel

Location

MeSH Terms

Conditions

PainBronchiolitis Obliterans Syndrome

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsOrganizing PneumoniaBronchiolitis ObliteransBronchiolitisBronchitisBronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesGraft vs Host DiseaseImmune System Diseases

Study Officials

  • Gabriel Zeilig, MD

    Sheba Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 8, 2012

First Posted

November 15, 2012

Study Start

December 1, 2012

Primary Completion

August 1, 2019

Study Completion

August 1, 2019

Last Updated

August 28, 2018

Record last verified: 2018-08

Locations

IL(1)