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

NCT ID: NCT01726881

Last Updated: 2018-08-28

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-12-31
• Study Completion Date: 2019-08-31

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.

Conditions

Pain; Healthy

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Fresh Spinal Cord Injury patients

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.

Group Type: EXPERIMENTAL

Thermal stimulation

Intervention Type: DEVICE

Stimulation using a Thermal Sensory Analyzer:

2001, Maddock ltd., Israel.

Mechanical stimulation

Intervention Type: DEVICE

Stimulation using Semmes-Weinstein-Monofilament Touch Test Sensory Evaluators

Chronic Spinal Cord Injury patients

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

Group Type: EXPERIMENTAL

Thermal stimulation

Intervention Type: DEVICE

Stimulation using a Thermal Sensory Analyzer:

2001, Maddock ltd., Israel.

Mechanical stimulation

Intervention Type: DEVICE

Stimulation using Semmes-Weinstein-Monofilament Touch Test Sensory Evaluators

Transcutaneous Electrical Nerve Stimulator (TENS)

Intervention Type: DEVICE

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

Healthy volunteers

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

Group Type: ACTIVE_COMPARATOR

Thermal stimulation

Intervention Type: DEVICE

Stimulation using a Thermal Sensory Analyzer:

2001, Maddock ltd., Israel.

Mechanical stimulation

Intervention Type: DEVICE

Stimulation using Semmes-Weinstein-Monofilament Touch Test Sensory Evaluators

Interventions

Thermal stimulation

Stimulation using a Thermal Sensory Analyzer:

2001, Maddock ltd., Israel.

Intervention Type: DEVICE

Mechanical stimulation

Stimulation using Semmes-Weinstein-Monofilament Touch Test Sensory Evaluators

Intervention Type: DEVICE

Transcutaneous Electrical Nerve Stimulator (TENS)

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

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Sheba Medical Center

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gabriel Zeilig, MD

Role: PRINCIPAL_INVESTIGATOR

Sheba Hospital

Locations

Sheba Medical Center rehabilitaion facility

Ramat Gan, , Israel

Countries

Israel

Other Identifiers

SHEBA-12-9572-GZ-SMC

Identifier Type: -

Identifier Source: org_study_id