Chronic Low Back PainNCT01620775
MR(Magnetic Resonance) Imaging of Neurotransmitters in Chronic Pain
A study testing MRIs and Pain testing in people with Chronic Low Back Pain and Diabetic Peripheral Neuropathy, run by University of Michigan at 1 site in United States.
Trial summary
This study is designed to assess: Hypothesis #1: That there is a significant central pain component in a distinct subset of patients diagnosed with knee osteoarthritis(KOA), Chronic low back pain(CLBP), painful diabetic neuropathy(PDN.) Hypothesis # 2: To establish a reliable strategy for differentiation of central… Read more about this study
- Who is it for?
- Ages 30 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Low Back Pain, Diabetic Peripheral Neuropathy, Knee Osteoarthritis
- What is being tested?
- MRIs and Pain testing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 87 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2012to 7 Jun 2017
- 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 30 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Must be Right Handed.
- (Chronic Pain with knee osteoarthritis)
- Diagnosed with: unilateral, symptomatic knee osteoarthritis based on American College of Rheumatology (ACR) criteria.
- Have had a knee x-ray within the last 6 months.
- Must have average pain intensity of 4 or greater on a 0 (no pain) to 10 (worst pain imaginable) scale.
- (Chronic Low Back Pain)
Show all 18Show fewer
- Have primary complaint of constant or intermittent back pain of at least 6 months duration.
- Have a Roland Morris Disability Questionnaire score of >7.
- (Diabetes Mellitus with Painful Peripheral Neuropathy)
- Have a diagnosis of diabetes mellitus for at least 6 months.
- Have a diagnosis of diabetic peripheral neuropathy.
- Have had Electromyography(EMG) testing within the last 6 months.
- Have a >40 mm score on the short-form McGill Pain questionnaire.
- (Healthy controls)
- Must be pain free
- No history of neurological or psychiatric illness.
- No diagnosis of Diabetes Mellitus.
- No evidence of neuropathy on clinical assessment.
Who cannot join
- Being pregnant.
- Have metal in the body or other contraindications to Magnetic Resonance Imaging (MRI).
- Have a chronic pain condition unrelated to knee osteoarthritis, chronic low back pain or diabetes.
- Have currently or a history of brain infection, stroke or tumor.
- Have a risk factor for other non-diabetic neuropathies
Trial locations and contacts
1 site in 1 country.
About this study
Official title: MR (Magnetic Resonance) Imaging of the Excitatory and Inhibitory Neurotransmitters in Chronic Pain
This study is designed to assess:
Hypothesis #1: That there is a significant central pain component in a distinct subset of patients diagnosed with knee osteoarthritis(KOA), Chronic low back pain(CLBP), painful diabetic neuropathy(PDN.)
Hypothesis # 2: To establish a reliable strategy for differentiation of central pain predominant from peripheral pain predominant knee osteoarthritis(KOA), chronic low back pain(CLBP)and peripheral diabetic neuropathy(PDN) patients using clinical features, experimental pain testing and magnetic resonance(MR) Spectroscopy.
Read the detailed description
This study will identify clinical and neuroimaging markers in chronic pain in an effort to provide individual-based treatments. This study will differentiate chronic pain subjects (knee osteoarthritis, low back pain and painful diabetic neuropathy) into two groups: those who have central pain predominant symptoms and those who have peripheral pain predominant symptoms. The response to medical treatment between these two groups is quite different, thus a reliable strategy to correctly categorize chronic pain sufferers offers the opportunity to provide targeted, effective treatments. Chronic pain is a prevalent problem in the VA veteran population with significant associated costs; in particular knee osteoarthritis, chronic low back pain and painful diabetic neuropathy are common in this population. The proposed study will use different clinical pain tests and advanced neuroimaging techniques to improve our understanding of chronic pain and improve patient outcomes.
- Being tested
- MRIs, Pain testing
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRIsOther
Subjects will have an MRI scan to view specific images, and brain activity patterns thought to be affected in patients with KOA, chronic low back pain and diabetic patients with painful neuropathy. Healthy volunteers will undergo the same MRI scan that lasts about 90 min.
Pain testingOther
There will be a 1-1.5 hour session including pain tolerance testing.
| Study group | Role | What they receive |
|---|---|---|
| Knee osteoarthritis (MRI, surveys, pain testing) | Experimental | Subjects previously diagnosed with knee osteoarthritis will have an MRI with imaging that measures brain metabolites. There are surveys to complete and a session of pain tolerance testing. Receives: Other: MRIs; Other: Pain testing |
| Healthy controls (MRI, surveys,pain testing) | Active comparator | Healthy volunteers will have an MRI with imaging that measures brain metabolites. There are surveys to complete and a session of pain tolerance testing. Receives: Other: MRIs; Other: Pain testing |
| diabetic peripheral neuropathy | Experimental | Subjects previously diagnosed with diabetic peripheral neuropathy will have an MRI with imaging that measures brain metabolites. There are surveys to complete and a session of pain tolerance testing. Receives: Other: MRIs; Other: Pain testing |
| chronic low back pain | Experimental | Subjects previously diagnosed with chronic low back pain will have an MRI with imaging that measures brain metabolites. There are surveys to complete and a session of pain tolerance testing. Receives: Other: MRIs; Other: Pain testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of chronic pain
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2012 (estimated)
- Study startSep 2012
- Primary completion7 Jun 2017
- Study completion7 Jun 2017
Why it stopped: Principal Investigator was unable to fulfill his responsibilities.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Low Back PainStudies of the same condition, open and under way.
- More trials run by University of MichiganThe 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Foerster Bradley, M.D., Principal investigator, University of MichiganBradley Foerster, M.D., Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01620775
- Sponsor's protocol ID
- HUM00055261
- Status last verified
- May 2018
- First submitted
- 13 Jun 2012
- Last updated
- 4 Jun 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MR (Magnetic Resonance) Imaging of the Excitatory and Inhibitory Neurotransmitters in Chronic Pain
- ClinicalTrials.gov ID
- NCT01620775
- Acronym / sponsor ID
- HUM00055261
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Principal Investigator was unable to fulfill his responsibilities.
- Enrolment
- 87 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- 7 Jun 2017 (actual)
- Study completion
- 7 Jun 2017 (actual)
- First posted
- 15 Jun 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.
This study is designed to assess:
Hypothesis #1: That there is a significant central pain component in a distinct subset of patients diagnosed with knee osteoarthritis(KOA), Chronic low back pain(CLBP), painful diabetic neuropathy(PDN.)
Hypothesis # 2: To establish a reliable strategy for differentiation of central pain predominant from peripheral pain predominant knee osteoarthritis(KOA), chronic low back pain(CLBP)and peripheral diabetic neuropathy(PDN) patients using clinical features, experimental pain testing and magnetic resonance(MR) Spectroscopy.
Detailed description
This study will identify clinical and neuroimaging markers in chronic pain in an effort to provide individual-based treatments. This study will differentiate chronic pain subjects (knee osteoarthritis, low back pain and painful diabetic neuropathy) into two groups: those who have central pain predominant symptoms and those who have peripheral pain predominant symptoms. The response to medical treatment between these two groups is quite different, thus a reliable strategy to correctly categorize chronic pain sufferers offers the opportunity to provide targeted, effective treatments. Chronic pain is a prevalent problem in the VA veteran population with significant associated costs; in particular knee osteoarthritis, chronic low back pain and painful diabetic neuropathy are common in this population. The proposed study will use different clinical pain tests and advanced neuroimaging techniques to improve our understanding of chronic pain and improve patient outcomes.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Knee osteoarthritis (MRI, surveys, pain testing) | Experimental | Other: MRIs, Other: Pain testingSubjects previously diagnosed with knee osteoarthritis will have an MRI with imaging that measures brain metabolites. There are surveys to complete and a session of pain tolerance testing. |
| Healthy controls (MRI, surveys,pain testing) | Active comparator | Other: MRIs, Other: Pain testingHealthy volunteers will have an MRI with imaging that measures brain metabolites. There are surveys to complete and a session of pain tolerance testing. |
| diabetic peripheral neuropathy | Experimental | Other: MRIs, Other: Pain testingSubjects previously diagnosed with diabetic peripheral neuropathy will have an MRI with imaging that measures brain metabolites. There are surveys to complete and a session of pain tolerance testing. |
| chronic low back pain | Experimental | Other: MRIs, Other: Pain testingSubjects previously diagnosed with chronic low back pain will have an MRI with imaging that measures brain metabolites. There are surveys to complete and a session of pain tolerance testing. |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Must be Right Handed.
- (Chronic Pain with knee osteoarthritis)
- Diagnosed with: unilateral, symptomatic knee osteoarthritis based on American College of Rheumatology (ACR) criteria.
- Have had a knee x-ray within the last 6 months.
- Must have average pain intensity of 4 or greater on a 0 (no pain) to 10 (worst pain imaginable) scale.
Key exclusion criteria (5 listed)
- Being pregnant.
- Have metal in the body or other contraindications to Magnetic Resonance Imaging (MRI).
- Have a chronic pain condition unrelated to knee osteoarthritis, chronic low back pain or diabetes.
- Have currently or a history of brain infection, stroke or tumor.
- Have a risk factor for other non-diabetic neuropathies
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 |
|---|---|---|
| MRIsSubjects will have an MRI scan to view specific images, and brain activity patterns thought to be affected in patients with KOA, chronic low back pain and diabetic patients with painful neuropathy. Healthy volunteers will undergo the same MRI scan that lasts about 90 min. | Other | Healthy controls (MRI, surveys,pain testing), Knee osteoarthritis (MRI, surveys, pain testing), chronic low back pain, diabetic peripheral neuropathy |
| Pain testingThere will be a 1-1.5 hour session including pain tolerance testing. | Other | Healthy controls (MRI, surveys,pain testing), Knee osteoarthritis (MRI, surveys, pain testing), chronic low back pain, diabetic peripheral neuropathy |
Primary outcome
Assessment of chronic pain
Time frame: 2 years
Results and safety
The study was stopped early (reason given: Principal Investigator was unable to fulfill his responsibilities.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2018.
- Individual participant dataSharing planned: No
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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.
Foerster Bradley, M.D. principal investigator
University of Michigan
Bradley Foerster, M.D. principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MRIs and Pain testing in people with Chronic Low Back Pain and Diabetic Peripheral Neuropathy, run by University of Michigan 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 18 inclusion and 5 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: stopped early, as of the sponsor's last update on 4 Jun 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 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 was stopped early (reason given: Principal Investigator was unable to fulfill his responsibilities.). 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?
Assessment of chronic pain (time frame: 2 years). 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 4 Jun 2018.