Neuropathic Pain From Spinal Cord InjuryNCT00623961
Validation Study of Neuropathic Pain
An observational study of Neuropathic Pain From Spinal Cord Injury and Diabetic Peripheral Neuropathy, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
This study seeks to validate clinically evoked or obtained objective pain signs with the patient's corresponding quantified subjective pain symptoms. This will allow for validation of objective clinical pain signs to then be used to begin to classify patients with pain based on symptoms and signs. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neuropathic Pain From Spinal Cord Injury, Diabetic Peripheral Neuropathy, Post Herpetic Pain
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2007to Feb 2011
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with neuropathic pain from the following diagnosis groups: post-herperic neuralgia, painful diabetic neuropathy, and spinal cord injury will be included in the study if their pain is of at least 6 months duration.
Who may be able to join
- Subjects must be 18 years of age and older, and able to provide informed consent and communicate in English. Pain rating inclusion criteria will be pain greater than 3 up to 9, as rated on the 0-10 pain scale, where 10 is the worst pain imaginable. This rating is based on the numeric pain rating scale (NPRS).
- PHN - Subjects with PHN will have a history of pain of at least 6 months duration in the area that was the site of a zoster rash resulting in nerve injury. In most cases, subjects experience a number of sensory abnormalities in the affected area, ranging from pain to numbness, and various degrees of hypersensitivity. Subjects with PHN must otherwise be in stable health. Pain rating inclusion criteria for PHN subjects will be pain greater than 3 up to 9, as rated on the 0-10 pain scale, where 10 is the worst pain imaginable.
- PDN - Subjects with diabetes mellitus and neuropathy who have a history of pain, predominantly in the lower extremities, of at least 6 months duration qualify for the diagnosis of PDN for purposes of this study. In most cases PDN is due to small fiber neuropathy, so physical examination should yield sensory abnormalities, such as pain, paresthesiae and numbness. Motor function and stretch reflex abnormalities are common but not necessary for inclusion. PDN patients in whom large fiber functions are affected, experience weakness and decreased or absent stretch reflexes, respectively, and are eligible for this study. Other causes of neuropathy will be excluded. PDN patients with pain rating of greater than 3 up to 9 on 0-10 scale will be included.
- SCI pain - Subjects with SCI and pain of at least 6 months duration will be invited to participate. In most cases, these subjects' sensory, motor and stretch reflex abnormalities are consistent with SCI. Sensory findings range form complete loss of sensation to preservation of all sensory modalities. Motor findings range from mild weakness to complete paralysis. Stretch reflexes are most frequently increased though in a few patients they can be absent. Based on the constellation of sensory and motor findings in particular patients, diagnosis of complete versus incomplete SCI is made. In this study we will study patients with incomplete SCI who have pain at level of injury or below level of injury, or both. Subjects with SCI who have pain rating of greater than 3 up to 9 on 0-10 scale will be included.
Who cannot join
- Patients with pain due to disorders other than PDN, PTN, or SCI, as well as unknown causes, will be excluded.
- Patients with neuropathies from causes such as vasculitis, demyelinating polyneuropathies, HIV-associated neuropathy, and paraneoplastic and post-infectious neuropathies will be excluded.
- Patients with chemotherapy-induced neuropathy will be excluded.
- Patients who suffer from pain due to different pain mechanisms will be excluded.
- Patients with other pain (at a different site) that is more severe than their PDN or PTN pain will be excluded.
- Patients with a history of recent or ongoing alcohol or other drug addiction disorders (as self-reported or previously documented in the medical record) will be excluded.
- Patients who are determined to have cognitive and reading impairments which would preclude them from completing questionnaires will be excluded.
- Patients whose chronic medical and psychiatric comorbidities are not under optimal control, or who are currently experiencing an acute exacerbation of a medical or psychiatric comorbidity, will be excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Validation Study of Positive Phenomena in Neuropathic Pain
This study seeks to validate clinically evoked or obtained objective pain signs with the patient's corresponding quantified subjective pain symptoms. This will allow for validation of objective clinical pain signs to then be used to begin to classify patients with pain based on symptoms and signs. This then can be used as a basis for further study of neuropathic pain mechanisms in human patients.
- Conditions
- Neuropathic Pain From Spinal Cord Injury, Diabetic Peripheral Neuropathy, Post Herpetic Pain
- Keywords
- Neuropathic Pain
- Medical subject headings
- Neuralgia
What is being measured
The primary outcome is the main question the study is designed to answer.
Validation of neuropathic pain sensory sign and corresponding symptoms
Measured: Two weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2008 (estimated)
- Study startApr 2007
- Primary completionFeb 2011
- Study completionFeb 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuropathic Pain From Spinal Cord InjuryStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Miroslav Backonja, MD, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00623961
- Sponsor's protocol ID
- 2006-0425
- Status last verified
- Jun 2010
- First submitted
- 14 Feb 2008
- Last updated
- 13 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation Study of Positive Phenomena in Neuropathic Pain
- ClinicalTrials.gov ID
- NCT00623961
- Acronym / sponsor ID
- 2006-0425
- Conditions
- Neuropathic Pain From Spinal Cord Injury, Diabetic Peripheral Neuropathy, Post Herpetic Pain
- Keywords
- Neuropathic Pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Study start
- Apr 2007
- Primary completion
- Feb 2011 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 26 Feb 2008 (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.
This study seeks to validate clinically evoked or obtained objective pain signs with the patient's corresponding quantified subjective pain symptoms. This will allow for validation of objective clinical pain signs to then be used to begin to classify patients with pain based on symptoms and signs. This then can be used as a basis for further study of neuropathic pain mechanisms in human patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with neuropathic pain from the following diagnosis groups: post-herperic neuralgia, painful diabetic neuropathy, and spinal cord injury will be included in the study if their pain is of at least 6 months duration.
Key inclusion criteria (4 listed)
- Subjects must be 18 years of age and older, and able to provide informed consent and communicate in English. Pain rating inclusion criteria will be pain greater than 3 up to 9, as rated on the 0-10 pain scale, where 10 is the worst pain imaginable. This rating is based on the numeric pain rating scale (NPRS).
- PHN - Subjects with PHN will have a history of pain of at least 6 months duration in the area that was the site of a zoster rash resulting in nerve injury. In most cases, subjects experience a number of sensory abnormalities in the affected area, ranging from pain to numbness, and various degrees of hypersensitivity. Subjects with PHN must otherwise be in stable health. Pain rating inclusion criteria for PHN subjects will be pain greater than 3 up to 9, as rated on the 0-10 pain scale, where 10 is the worst pain imaginable.
- PDN - Subjects with diabetes mellitus and neuropathy who have a history of pain, predominantly in the lower extremities, of at least 6 months duration qualify for the diagnosis of PDN for purposes of this study. In most cases PDN is due to small fiber neuropathy, so physical examination should yield sensory abnormalities, such as pain, paresthesiae and numbness. Motor function and stretch reflex abnormalities are common but not necessary for inclusion. PDN patients in whom large fiber functions are affected, experience weakness and decreased or absent stretch reflexes, respectively, and are eligible for this study. Other causes of neuropathy will be excluded. PDN patients with pain rating of greater than 3 up to 9 on 0-10 scale will be included.
- SCI pain - Subjects with SCI and pain of at least 6 months duration will be invited to participate. In most cases, these subjects' sensory, motor and stretch reflex abnormalities are consistent with SCI. Sensory findings range form complete loss of sensation to preservation of all sensory modalities. Motor findings range from mild weakness to complete paralysis. Stretch reflexes are most frequently increased though in a few patients they can be absent. Based on the constellation of sensory and motor findings in particular patients, diagnosis of complete versus incomplete SCI is made. In this study we will study patients with incomplete SCI who have pain at level of injury or below level of injury, or both. Subjects with SCI who have pain rating of greater than 3 up to 9 on 0-10 scale will be included.
Key exclusion criteria (8 listed)
- Patients with pain due to disorders other than PDN, PTN, or SCI, as well as unknown causes, will be excluded.
- Patients with neuropathies from causes such as vasculitis, demyelinating polyneuropathies, HIV-associated neuropathy, and paraneoplastic and post-infectious neuropathies will be excluded.
- Patients with chemotherapy-induced neuropathy will be excluded.
- Patients who suffer from pain due to different pain mechanisms will be excluded.
- Patients with other pain (at a different site) that is more severe than their PDN or PTN pain will be excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Validation of neuropathic pain sensory sign and corresponding symptoms
Time frame: Two weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2015.
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.
Miroslav Backonja, MD principal investigator
University of Wisconsin, Madison
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neuropathic Pain From Spinal Cord Injury and Diabetic Peripheral Neuropathy, run by University of Wisconsin, Madison at 1 site in United States.
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 4 inclusion and 8 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: finished, as of the sponsor's last update on 13 Jan 2015. 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Validation of neuropathic pain sensory sign and corresponding symptoms (time frame: Two weeks). 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 13 Jan 2015.