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

This study is enrolling participants by invitation only.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01726881
First Posted: November 15, 2012
Last Update Posted: January 4, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Sheba Medical Center
  Purpose

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.


Condition Intervention
Pain Healthy Device: Thermal stimulation Device: Mechanical stimulation Device: Transcutaneous Electrical Nerve Stimulator (TENS)

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Predicting Central Pain Among People With a Spinal Cord Injury by Evaluating Mechanisms Regulating Pain and Efficacy Testing of the TENS Apparatus

Resource links provided by NLM:


Further study details as provided by Sheba Medical Center:

Primary Outcome Measures:
  • Sensitivity to thermic pain [ Time Frame: 5 minutes ]
    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.

  • Pain suppression capability [ Time Frame: 5 minutes ]
    Reduction of pain in the presence of another stimulus. pain will be reported using a visual analog scale - a pain scale between 1-10.

  • Habituation to tonic stimulation [ Time Frame: 5 minutes ]
    Gradient decrease in pain rating. pain will be reported using a visual analog scale - a pain scale between 1-10.

  • Temporal summation of pain [ Time Frame: 5 minutes ]
    Standard rating of pain among several stimuli. pain will be reported using a visual analog scale - a pain scale between 1-10.


Estimated Enrollment: 120
Study Start Date: December 2012
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Fresh Spinal Cord Injury patients
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 stimulation

Stimulation using a Thermal Sensory Analyzer:

2001, Maddock ltd., Israel.

Device: Mechanical stimulation
Stimulation using Semmes-Weinstein-Monofilament Touch Test Sensory Evaluators
Experimental: Chronic Spinal Cord Injury patients
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 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.
Active Comparator: Healthy volunteers
Healthy subjects that will over go several tests and will fill out several questionnaires
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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01726881


Locations
Israel
Sheba Medical Center rehabilitaion facility
Ramat Gan, Israel
Sponsors and Collaborators
Sheba Medical Center
Investigators
Principal Investigator: Gabriel Zeilig, MD Sheba Hospital
  More Information

Responsible Party: Sheba Medical Center
ClinicalTrials.gov Identifier: NCT01726881     History of Changes
Other Study ID Numbers: SHEBA-12-9572-GZ-SMC
First Submitted: November 8, 2012
First Posted: November 15, 2012
Last Update Posted: January 4, 2017
Last Verified: January 2017

Keywords provided by Sheba Medical Center:
chronic
Spinal Cord Injury patients

Additional relevant MeSH terms:
Spinal Cord Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries