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Predicting Central Pain Among People With SCI by Evaluating Mechanisms Regulating Pain and Efficacy Testing of the TENS Apparatus

This study is not yet open for participant recruitment.
Verified November 2012 by Sheba Medical Center
Sponsor:
Information provided by (Responsible Party):
Sheba Medical Center
ClinicalTrials.gov Identifier:
NCT01726881
First received: November 8, 2012
Last updated: November 14, 2012
Last verified: November 2012
History of Changes
  Purpose

People with SCI (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 SCI 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 SCI 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 SCI 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 SCI 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: Open Label
Primary Purpose: Diagnostic

Further study details as provided by Sheba Medical Center:

Primary Outcome Measures:
  • Sensitivity to thermic pain [ Time Frame: 5 minutes ] [ Designated as safety issue: No ]
    Minimum temperature at which the patient reported pain. The subject will press a button once feeling pain. pain will be reported using the VAS (visual analog scale) - a pain scale between 1-10.

  • Pain suppression capability [ Time Frame: 5 minutes ] [ Designated as safety issue: No ]
    Reduction of pain in the presence of another stimulus. pain will be reported using the VAS (visual analog scale) - a pain scale between 1-10.

  • Habituation to tonic stimulation [ Time Frame: 5 minutes ] [ Designated as safety issue: No ]
    Gradient decrease in pain rating. pain will be reported using the VAS (visual analog scale) - a pain scale between 1-10.

  • Temporal summation of pain [ Time Frame: 5 minutes ] [ Designated as safety issue: No ]
    Standard rating of pain among several stimuli. pain will be reported using the VAS (visual analog scale) - a pain scale between 1-10.


Estimated Enrollment: 120
Study Start Date: December 2012
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Fresh SCI patients
SCI patients that are currently adimitted to the rehabilitation unit with three weeks or less since injury that will overgo several tests and will fill out several questionnaires.
 Device: Thermal stimulation

Stimulation using a Thermal Sensory Analyzer:

TSA 2001, Madock ltd., Ramat yishay, Israel.

Device: Mechanical stimulation
Stimulation using Semmes-Weinstein-Monofilament Touch Test Sensory Evaluators
Experimental: Chronic SCI patients
SCI patients with one year or more since injury that will overgo several tests and will fill out several questionnaires
 Device: Thermal stimulation

Stimulation using a Thermal Sensory Analyzer:

TSA 2001, Madock ltd., Ramat yishay, 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- Cefar rehab X2. Chattanooga group-A DJO Company.USA.
Active Comparator: Healthy volanteers
Healthy subjects that will overgo several tests and will fill out several questionnaires
 Device: Thermal stimulation

Stimulation using a Thermal Sensory Analyzer:

TSA 2001, Madock ltd., Ramat yishay, Israel.

Device: Mechanical stimulation
Stimulation using Semmes-Weinstein-Monofilament Touch Test Sensory Evaluators

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • for all subjects:

    • age - 18-70
    • Cognitive status that allows voluntary cooperation understanding of instruction

  • for chronic SCI subjects:

    • spinal cord injury (complete and incomplete)
    • height of injury - under 7C
    • time since injury - one year or more.

  • for chronic SCI subjects:

    • spinal cord injury (complete and incomplete)
    • height of injury - under 7C
    • 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01726881

Contacts
Contact: Gabriel Zeilig, MD 972-3-5303725 Gabi.Zeilig@sheba.health.gov.il

Locations
Israel
Sheba Medical Center rehabilitaion facility Not yet recruiting
Ramat Gan, Israel
Contact: Gabriel Zeilig, MD     972-3-5303725     Gabi.Zeilig@sheba.health.gov.il    
Principal Investigator: Gabriel Zeilig, MD            
Sponsors and Collaborators
Sheba Medical Center
Investigators
Principal Investigator: Gabriel Zeilig, MD Sheba Hospital
  More Information

No publications provided

Responsible Party: Sheba Medical Center
ClinicalTrials.gov Identifier: NCT01726881     History of Changes
Other Study ID Numbers: SHEBA-12-9572-GZ-SMC
Study First Received: November 8, 2012
Last Updated: November 14, 2012
Health Authority: Israel: Ministry of Health

Keywords provided by Sheba Medical Center:
chronic
SCI patients

ClinicalTrials.gov processed this record on May 23, 2013