PainNCT01726881
Predicting Central Pain Among People With a Spinal Cord Injury by Evaluating Mechanisms Regulating Pain and Efficacy Testing of the TENS Apparatus
A study testing Thermal stimulation, Mechanical stimulation and Transcutaneous Electrical Nerve Stimulator (TENS) in people with Pain and Healthy, run by Sheba Medical Center at 1 site in Israel.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- What is being tested?
- Thermal stimulation, Mechanical stimulation and Transcutaneous Electrical Nerve Stimulator (TENS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteIsrael
- Study dates
- Dec 2012to Aug 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 11Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Being tested
- Thermal stimulation, Mechanical stimulation, Transcutaneous Electrical Nerve Stimulator (TENS)
- Keywords
- chronic, Spinal Cord Injury patients
- Medical subject headings
- Pain, Bronchiolitis Obliterans Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thermal stimulationDevice
Stimulation using a Thermal Sensory Analyzer:
2001, Maddock ltd., Israel.
Mechanical stimulationDevice
Stimulation using Semmes-Weinstein-Monofilament Touch Test Sensory Evaluators
Transcutaneous Electrical Nerve Stimulator (TENS)Device
A portable stimulator designed to Physical treatment of pain. TENS - Cedar rehab X2. Chattanooga group.USA.
| Study group | Role | What they receive |
|---|---|---|
| Fresh Spinal Cord Injury patients | Experimental | 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. Receives: Device: Thermal stimulation; Device: Mechanical stimulation |
| Chronic Spinal Cord Injury patients | Experimental | Spinal Cord Injury patients with one year or more since injury that will over go several tests and will fill out several questionnaires Receives: Device: Thermal stimulation; Device: Mechanical stimulation; Device: Transcutaneous Electrical Nerve Stimulator (TENS) |
| Healthy volunteers | Active comparator | Healthy subjects that will over go several tests and will fill out several questionnaires Receives: Device: Thermal stimulation; Device: Mechanical stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 minutes
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.
Measured: 5 minutes
Habituation to tonic stimulation
Gradient decrease in pain rating. pain will be reported using a visual analog scale - a pain scale between 1-10.
Measured: 5 minutes
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.
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2012 (estimated)
- Study startDec 2012
- Primary completionAug 2019 (estimated)
- Study completionAug 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by Sheba Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Gabriel Zeilig, MD, Principal investigator, Sheba Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01726881
- Sponsor's protocol ID
- SHEBA-12-9572-GZ-SMC
- Status last verified
- Aug 2018
- First submitted
- 8 Nov 2012
- Last updated
- 28 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predicting Central Pain Among People With a Spinal Cord Injury by Evaluating Mechanisms Regulating Pain and Efficacy Testing of the TENS Apparatus
- ClinicalTrials.gov ID
- NCT01726881
- Acronym / sponsor ID
- SHEBA-12-9572-GZ-SMC
- Keywords
- chronic, Spinal Cord Injury patients
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- Dec 2012
- Primary completion
- Aug 2019 (estimated)
- Study completion
- Aug 2019 (estimated)
- First posted
- 15 Nov 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Fresh Spinal Cord Injury patients | Experimental | Device: Thermal stimulation, Device: Mechanical stimulationSpinal 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. |
| Chronic Spinal Cord Injury patients | Experimental | Device: Thermal stimulation, Device: Mechanical stimulation, Device: Transcutaneous Electrical Nerve Stimulator (TENS)Spinal Cord Injury patients with one year or more since injury that will over go several tests and will fill out several questionnaires |
| Healthy volunteers | Active comparator | Device: Thermal stimulation, Device: Mechanical stimulationHealthy subjects that will over go several tests and will fill out several questionnaires |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- for all subjects:
- for chronic Spinal Cord Injury subjects:
- for chronic Spinal Cord Injury subjects:
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Thermal stimulationStimulation using a Thermal Sensory Analyzer: 2001, Maddock ltd., Israel. | Device | Chronic Spinal Cord Injury patients, Fresh Spinal Cord Injury patients, Healthy volunteers |
| Mechanical stimulationStimulation using Semmes-Weinstein-Monofilament Touch Test Sensory Evaluators | Device | Chronic Spinal Cord Injury patients, Fresh Spinal Cord Injury patients, Healthy volunteers |
| Transcutaneous Electrical Nerve Stimulator (TENS)A portable stimulator designed to Physical treatment of pain. TENS - Cedar rehab X2. Chattanooga group.USA. | Device | Chronic Spinal Cord Injury patients |
Primary outcome
Sensitivity to thermic pain
Time frame: 5 minutes
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.
Pain suppression capability
Time frame: 5 minutes
Reduction 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 stimulation
Time frame: 5 minutes
Gradient decrease in pain rating. pain will be reported using a visual analog scale - a pain scale between 1-10.
Temporal summation of pain
Time frame: 5 minutes
Standard rating of pain among several stimuli. pain will be reported using a visual analog scale - a pain scale between 1-10.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2018.
Related trials for Pain
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Recruiting
Empowered Relief® for Cancer Survivors With Chronic Pain
Chronic Pain Due to Cancer, Pain Catastrophizing
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
RecruitingObservational study
Pain Phenotypes in Individuals With Multiple Sclerosis
Multiple Sclerosis, Chronic Pain
Not yet recruiting
Effects of Hip Hinge Exercises on Pain, Range of Motion and Functional Disability in Non-specific Low Back Pain.
Low Back Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gabriel Zeilig, MD principal investigator
Sheba Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Thermal stimulation, Mechanical stimulation and Transcutaneous Electrical Nerve Stimulator (TENS) in people with Pain and Healthy, run by Sheba Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity to thermic pain (time frame: 5 minutes). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2018.