- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04880408
Morphological and Metabolic Changes of Dorsal Root Ganglion and Sympathetic Ganglion in Patients With Postherpetic Neuralgia on MRI
October 1, 2022 updated by: Xianwei Zhang,MD, Huazhong University of Science and Technology
Object: Postherpetic neuralgia (PHN) is pain that persists for 1-3 months after herpes zoster onset.
It is the most common complication of herpes zoster and occurs in 15-40% of patients with herpes zoster.
PHN has been suggested to be related with the lesion of doral root ganglion (DRG).
However, the studies are almost limited to autopsies and animals , and the mechanism of PHN is still unclear.
This study was conducted to investigate morphological and metabolic changes of DRG and sympathetic ganglion in patients with postherpetic neuralgia on MRI.
Method: 30 patients diagnosed as PHN were recruited.
The volume and fractional anisotropy of DRG of lesion dermatomes were measured under MRI, and compared with contralateral and adjacent DRG.
The volume and fractional anisotropy of sympathetic ganglion of lesion dermatomes were also measured under MRI, and compared with contralateral and adjacent sympathetic ganglion.Then, the association between clinical phenotypes and DRG changes were analyzed.
Study Overview
Status
Recruiting
Conditions
Detailed Description
Patients with the following conditions were excluded: psychiatric diseases or communication disorders; contraindications to MRI;DRG radiofrequency therapy, spinal cord electrical stimulation and other direct intervention treatments for DRG were performed before examination.
Study Type
Observational
Enrollment (Anticipated)
30
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Xianwei Zhang, Doctor
- Phone Number: (+86)13037154560
- Email: znpain@sina.com
Study Locations
-
-
Hubei
-
Wuhan, Hubei, China, 430030
- Recruiting
- Department of Anesthesiology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
-
Contact:
- cai'e Zhang, Doctor
- Email: zhangcaie1972@126.com
-
Principal Investigator:
- Xueqin Cao, Doctor
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
patients with herpes zoster in cervical, thoracic,lumbar or sacral regions
Description
Inclusion Criteria:
- aged more than 18 herpes zoster in cervical, thoracic,lumbar or sacral regions agree to participate to the research
Exclusion Criteria:
- can not cooperate to MRI for mental disease contraindication for MRI treatments for DRG such as radiaofrequency therapy, spinal cord electircal stimulation were performed before examination. disagree to participate to the research
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Other
- Time Perspectives: Cross-Sectional
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
To compare the volume and fractional anisotropy of DRG between lesion dermatomes and contralateral dermatomes
Time Frame: 1 year
|
DRGs of lesion and contralateral dermatomes were scanned under MRI.
Then, the valume (the maximum cross-section area ×layers/2) and fractional anisotropy of DRGs were measured with RadiAnt DICOM Viewer, and the comparison was made between lesion and contralateral DRG.
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
To compare the volume and fractional anisotropy of sympathetic ganglion between lesion dermatomes and contralateral dermatomes.
Time Frame: 1 year
|
as primary outcome measure, sympathetic ganglions of lesion and contralateral dermatomes were scanned under MRI.
Then, the valume (the maximum cross-section area ×layers/2) and fractional anisotropy of sympathetic ganglions were measured with RadiAnt DICOM Viewer, and the comparison was made between lesion and contralateral sympathetic ganglions.
|
1 year
|
To compare the volume and fractional anisotropy of DRG between lesion dermatomes and adjacent dermatomes.
Time Frame: 1 year
|
DRGs of lesion and adjacent dermatomes were scanned under MRI.
Then, the valume (the maximum cross-section area ×layers/2) and fractional anisotropy of DRGs were measured with RadiAnt DICOM Viewer, and the comparison was made between lesion and adjacent DRG.
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Xianwei Zhang, Doctor, Huazhong University of Science and Technology
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2021
Primary Completion (Anticipated)
October 1, 2022
Study Completion (Anticipated)
October 1, 2022
Study Registration Dates
First Submitted
April 22, 2021
First Submitted That Met QC Criteria
May 5, 2021
First Posted (Actual)
May 10, 2021
Study Record Updates
Last Update Posted (Actual)
October 4, 2022
Last Update Submitted That Met QC Criteria
October 1, 2022
Last Verified
October 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- herpes zoster
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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