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The Impact of Epidural Steroid Analgesia on Functional MRI for Patients With LBP

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ClinicalTrials.gov Identifier: NCT01913782
Recruitment Status : Completed
First Posted : August 1, 2013
Last Update Posted : June 19, 2018
Sponsor:
Information provided by (Responsible Party):
Yen Chin Liu, National Cheng-Kung University Hospital

Brief Summary:

Chronic low back pain (CLBP) is the most prevalent form of chronic pain, and the most common reason for disability in working-age population [2]. CLBP has also been reported associated with many abnormal brain anatomy and function which includes the reduction in cortical gray matter in the bilateral dorsolateral prefrontal cortex (DLPFC), thalamus, brain stem, primary somatosensory cortex, and posterior parietal cortex. [3-5] There are already many studies that demonstrated abnormal cortical function for people with CLBP [6-10]. Meanwhile, DLPFC was also reported to be influenced by many pain process which included pain modulation [11-13], placebo analgesia [14, 15], pain control [16, 17]or pain catastrophizing[18]. And recent report has showed that effective treatment of chronic back pain patients reverses abnormal DLPFC function[19]. Meanwhile, epidural steroid injection has been performed in clinical for routinely managed for low back pain patients. Patients refused or have no indication for surgery or have little response to rehabilitation may consider this management. There was good evidence for short- and long-term relief of chronic pain secondary to disc herniation with local anesthetic and steroids[20, 21]. However, the impact of this treatment on functionalMRI (fMRI) has never been investigated. The investigators research will try to solve this issue.

This study will provide a good relationship for the pain fMRI image in brain after local lumbar spine management. And the investigators also want to perform the first data that showed local lumbar analgesia have the impact on brain image change.


Condition or disease
Chronic Low Back Pain

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Study Type : Observational
Actual Enrollment : 7 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: The Impact of Epidural Steroid Analgesia on Functional MRI for Patients With Low Back Pain
Actual Study Start Date : October 2012
Actual Primary Completion Date : April 2018
Actual Study Completion Date : June 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain

Group/Cohort
patients with low back pain
  1. Patients with disc herniation or radiculitis who are over 18 years of age.
  2. Patients with a history of chronic function-limiting low back pain and lower extremity pain for at least one months' duration.
  3. Patients who are competent to understand the study and provide written informed consent and participate in outcome measurements.



Primary Outcome Measures :
  1. The pain fMRI image in brain after local lumbar spine [ Time Frame: 14 months ]

Biospecimen Retention:   None Retained
fMRI image


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients who first visited in our pain clinic for low back pain with root sign will be included in this study.
Criteria

Inclusion Criteria:

  1. Patients with disc herniation or radiculitis who are over 18 years of age.
  2. Patients with a history of chronic function-limiting low back pain and lower extremity pain for at least one months' duration.
  3. Patients who are competent to understand the study and provide written informed consent and participate in outcome measurements.

Exclusion Criteria:

  • Patients have previous lumbar surgery with metal instrument. Initial MRI shows spinal stenosis or without disc herniation. Patients have unstable opioid use, uncontrolled psychiatric disorders, uncontrolled acute medical illness, any condition that could interfere with the interpretation of outcome assessments, pregnant or lactating women or allergy to local anesthetics or steroid. Patients who are unable to perform MRI or fMRI will also be excluded.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01913782


Locations
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Taiwan
National Cheng Kung University Hospital
Tainan City, Shengli Rd, Taiwan, 701
Sponsors and Collaborators
National Cheng-Kung University Hospital
Investigators
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Study Chair: Yen-Chin Liu, Doctor Department of Anesthesiology, National Cheng-Kung University Hospital

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Responsible Party: Yen Chin Liu, Visiting Staff, Department of Anesthesiology Chief, National Cheng-Kung University Hospital
ClinicalTrials.gov Identifier: NCT01913782    
Other Study ID Numbers: B-ER-101-143
First Posted: August 1, 2013    Key Record Dates
Last Update Posted: June 19, 2018
Last Verified: June 2018
Keywords provided by Yen Chin Liu, National Cheng-Kung University Hospital:
Chronic low back pain, CLBC, fMRI
Additional relevant MeSH terms:
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Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Signs and Symptoms