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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT01726881
• Other study ID #: SHEBA-12-9572-GZ-SMC
• Status: Enrolling by invitation
• Phase: N/A
• Start date: December 2012
• Est. completion date: August 2019

Study information

• Verified date: August 2018
• Source: Sheba Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 120
• Est. completion date: August 2019
• Est. primary completion date: August 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy
• Pain
• Spinal Cord Injuries

Intervention

Device:
• Thermal stimulation
Stimulation using a Thermal Sensory Analyzer: 2001, Maddock ltd., Israel.
• Mechanical stimulation
Stimulation using Semmes-Weinstein-Monofilament Touch Test Sensory Evaluators
• Transcutaneous Electrical Nerve Stimulator (TENS)
A portable stimulator designed to Physical treatment of pain. TENS - Cedar rehab X2. Chattanooga group.USA.

Locations

Country	Name	City	State
Israel	Sheba Medical Center rehabilitaion facility	Ramat Gan

Sponsors (1)

Lead Sponsor	Collaborator
Sheba Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensitivity to thermic pain	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.	5 minutes
Primary	Pain suppression capability	Reduction of pain in the presence of another stimulus. pain will be reported using a visual analog scale - a pain scale between 1-10.	5 minutes
Primary	Habituation to tonic stimulation	Gradient decrease in pain rating. pain will be reported using a visual analog scale - a pain scale between 1-10.	5 minutes
Primary	Temporal summation of pain	Standard rating of pain among several stimuli. pain will be reported using a visual analog scale - a pain scale between 1-10.	5 minutes