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

Not Applicable

• Conditions: Healthy; Pain
• Interventions: Device: Thermal stimulation; Device: Mechanical stimulation; Device: Transcutaneous Electrical Nerve Stimulator (TENS)

• Registration Number: NCT01726881
• Lead Sponsor: Sheba Medical Center

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2012-11-08
• Study First Submitted QC: 2012-11-14
• Study First Posted: 2012-11-15
• Study Start: 2012-12
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-27
• Last Update Posted: 2018-08-28
• Primary Completion: 2019-08
• Study Completion: 2019-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Healthy volunteers	Thermal stimulation	Healthy subjects that will over go several tests and will fill out several questionnaires
Fresh Spinal Cord Injury patients	Mechanical stimulation	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.
Fresh Spinal Cord Injury patients	Thermal stimulation	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.
Chronic Spinal Cord Injury patients	Thermal stimulation	Spinal Cord Injury patients with one year or more since injury that will over go several tests and will fill out several questionnaires
Chronic Spinal Cord Injury patients	Transcutaneous Electrical Nerve Stimulator (TENS)	Spinal Cord Injury patients with one year or more since injury that will over go several tests and will fill out several questionnaires
Chronic Spinal Cord Injury patients	Mechanical stimulation	Spinal Cord Injury patients with one year or more since injury that will over go several tests and will fill out several questionnaires
Healthy volunteers	Mechanical stimulation	Healthy subjects that will over go several tests and will fill out several questionnaires

Primary Outcome Measures

Name	Time	Method
Sensitivity to thermic pain	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.
Temporal summation of pain	5 minutes	Standard rating of pain among several stimuli. pain will be reported using a visual analog scale - a pain scale between 1-10.
Pain suppression capability	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	5 minutes	Gradient decrease in pain rating. pain will be reported using a visual analog scale - a pain scale between 1-10.

Trial Locations

Locations (1)

Sheba Medical Center rehabilitaion facility; 🇮🇱 Ramat Gan, Israel