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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

Primary Purpose

Pain, Healthy

Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Thermal stimulation
Mechanical stimulation
Transcutaneous Electrical Nerve Stimulator (TENS)
Sponsored by
Sheba Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Pain focused on measuring chronic, Spinal Cord Injury patients

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Sheba Medical Center rehabilitaion facility

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Fresh Spinal Cord Injury patients

Chronic Spinal Cord Injury patients

Healthy volunteers

Arm Description

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.

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
November 8, 2012
Last Updated
August 27, 2018
Sponsor
Sheba Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01726881
Brief Title
Predicting Central Pain Among People With a Spinal Cord Injury by Evaluating Mechanisms Regulating Pain and Efficacy Testing of the TENS Apparatus
Official Title
Predicting Central Pain Among People With a Spinal Cord Injury by Evaluating Mechanisms Regulating Pain and Efficacy Testing of the TENS Apparatus
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Unknown status
Study Start Date
December 2012 (undefined)
Primary Completion Date
August 2019 (Anticipated)
Study Completion Date
August 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sheba Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Healthy
Keywords
chronic, Spinal Cord Injury patients

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Fresh Spinal Cord Injury patients
Arm Type
Experimental
Arm Description
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.
Arm Title
Chronic Spinal Cord Injury patients
Arm Type
Experimental
Arm Description
Spinal Cord Injury patients with one year or more since injury that will over go several tests and will fill out several questionnaires
Arm Title
Healthy volunteers
Arm Type
Active Comparator
Arm Description
Healthy subjects that will over go several tests and will fill out several questionnaires
Intervention Type
Device
Intervention Name(s)
Thermal stimulation
Intervention Description
Stimulation using a Thermal Sensory Analyzer: 2001, Maddock ltd., Israel.
Intervention Type
Device
Intervention Name(s)
Mechanical stimulation
Intervention Description
Stimulation using Semmes-Weinstein-Monofilament Touch Test Sensory Evaluators
Intervention Type
Device
Intervention Name(s)
Transcutaneous Electrical Nerve Stimulator (TENS)
Intervention Description
A portable stimulator designed to Physical treatment of pain. TENS - Cedar rehab X2. Chattanooga group.USA.
Primary Outcome Measure Information:
Title
Sensitivity to thermic pain
Description
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.
Time Frame
5 minutes
Title
Pain suppression capability
Description
Reduction of pain in the presence of another stimulus. pain will be reported using a visual analog scale - a pain scale between 1-10.
Time Frame
5 minutes
Title
Habituation to tonic stimulation
Description
Gradient decrease in pain rating. pain will be reported using a visual analog scale - a pain scale between 1-10.
Time Frame
5 minutes
Title
Temporal summation of pain
Description
Standard rating of pain among several stimuli. pain will be reported using a visual analog scale - a pain scale between 1-10.
Time Frame
5 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gabriel Zeilig, MD
Organizational Affiliation
Sheba Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sheba Medical Center rehabilitaion facility
City
Ramat Gan
Country
Israel

12. IPD Sharing Statement

Learn more about this trial

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

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