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

Sheba Medical Center

Status: Unknown

Conditions: Healthy; Pain

Treatments: Device: Mechanical stimulation; Device: Transcutaneous Electrical Nerve Stimulator (TENS); Device: Thermal stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT01726881

SHEBA-12-9572-GZ-SMC

Details and patient eligibility

About

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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 3 patient groups

Fresh Spinal Cord Injury patients

Experimental group

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.

Treatment:

Device: Thermal stimulation

Device: Mechanical stimulation

Chronic Spinal Cord Injury patients

Experimental group

Description:

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

Treatment:

Device: Thermal stimulation

Device: Transcutaneous Electrical Nerve Stimulator (TENS)

Device: Mechanical stimulation

Healthy volunteers

Active Comparator group

Description:

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

Treatment:

Device: Thermal stimulation

Device: Mechanical stimulation