Skip to content

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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01726881
Enrollment
120
Registered
2012-11-15
Start date
2012-12-31
Completion date
2019-08-31
Last updated
2018-08-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy, Pain

Keywords

chronic, Spinal Cord Injury patients

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.

Interventions

Stimulation using a Thermal Sensory Analyzer: 2001, Maddock ltd., Israel.

Stimulation using Semmes-Weinstein-Monofilament Touch Test Sensory Evaluators

A portable stimulator designed to Physical treatment of pain. TENS - Cedar rehab X2. Chattanooga group.USA.

Sponsors

Sheba Medical Center
Lead SponsorOTHER_GOV

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Sensitivity to thermic pain5 minutesMinimum 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 capability5 minutesReduction 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 stimulation5 minutesGradient decrease in pain rating. pain will be reported using a visual analog scale - a pain scale between 1-10.
Temporal summation of pain5 minutesStandard rating of pain among several stimuli. pain will be reported using a visual analog scale - a pain scale between 1-10.

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026