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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

Unknown statusNot applicableNCT01726881
View the official record on ClinicalTrials.gov

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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.

Brief summary (from the registry)

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.

Study details

Official title
Predicting Central Pain Among People With a Spinal Cord Injury by Evaluating Mechanisms Regulating Pain and Efficacy Testing of the TENS Apparatus
Conditions
Interventions
  • Device: Thermal stimulation
  • Device: Mechanical stimulation
  • Device: Transcutaneous Electrical Nerve Stimulator (TENS)
Sponsor
Sheba Medical Center
Start date
2012-12
Primary completion
2019-08
Sex
All
Age range
from 18 Years to 70 Years
Healthy volunteers
true
Results posted
No results posted in this snapshot
Countries
Israel
Total sites listed
1

Eligibility criteria

Show eligibility criteria (verbatim from the registry)
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

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT01726881