Clinical trial NCT01726881: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Pain
Healthy
Keywords: chronic
Spinal Cord Injury patients
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2012-11-15
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.


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

Primary outcomes:
measure: Sensitivity to thermic pain
timeFrame: 5 minutes
measure: Pain suppression capability
timeFrame: 5 minutes
measure: Habituation to tonic stimulation
timeFrame: 5 minutes
measure: Temporal summation of pain
timeFrame: 5 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Ramat Gan
country: Israel
facility: Sheba Medical Center rehabilitaion facility
Study officials:
affiliation: Sheba Hospital
name: Gabriel Zeilig, MD
role: PRINCIPAL_INVESTIGATOR
References: