PainNCT04880408
Morphological and Metabolic Changes of Dorsal Root Ganglion and Sympathetic Ganglion in Patients With Postherpetic Neuralgia on MRI
An observational study of Pain and Neuropathy;Peripheral, run by Huazhong University of Science and Technology at 1 site in China.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain, Neuropathy;Peripheral
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2021to Oct 2022
- 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
- Adult, Older adult
Study population: patients with herpes zoster in cervical, thoracic,lumbar or sacral regions
Who may be able to join
- aged more than 18 herpes zoster in cervical, thoracic,lumbar or sacral regions agree to participate to the research
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Anesthesiology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430030
cai'e Zhang, Doctor, zhangcaie1972@126.com
Xueqin Cao, Doctor
About this study
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.
Read the 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.
- Conditions
- Pain, Neuropathy;Peripheral
- Keywords
- herpes zoster, postherpetic neuralgia, MRI, dorsal root ganglion
- Medical subject headings
- Pain, Neuritis, Herpes Zoster, Neuralgia, Postherpetic
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare the volume and fractional anisotropy of DRG between lesion dermatomes and contralateral dermatomes
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.
Measured: 1 year
Secondary outcomes (2)
To compare the volume and fractional anisotropy of sympathetic ganglion between lesion dermatomes and contralateral dermatomes.
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.
Measured: 1 year
To compare the volume and fractional anisotropy of DRG between lesion dermatomes and adjacent dermatomes.
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2021
- Study start1 Jan 2021
- Primary completionOct 2022 (estimated)
- Study completionOct 2022 (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 Huazhong University of Science and TechnologyThe 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Huazhong University of Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xianwei Zhang，MD, Huazhong University of Science and Technology
- Investigators
- Xianwei Zhang, Doctor, Principal investigator, Huazhong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04880408
- Sponsor's protocol ID
- herpes zoster
- Status last verified
- Oct 2022
- First submitted
- 22 Apr 2021
- Last updated
- 4 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Morphological and Metabolic Changes of Dorsal Root Ganglion and Sympathetic Ganglion in Patients With Postherpetic Neuralgia on MRI
- ClinicalTrials.gov ID
- NCT04880408
- Acronym / sponsor ID
- herpes zoster
- Conditions
- Pain, Neuropathy;Peripheral
- Keywords
- herpes zoster, postherpetic neuralgia, MRI, dorsal root ganglion
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Huazhong University of Science and TechnologyUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- Oct 2022 (estimated)
- Study completion
- Oct 2022 (estimated)
- First posted
- 10 May 2021 (actual)
- 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.
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.
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- patients with herpes zoster in cervical, thoracic,lumbar or sacral regions
Key inclusion criteria (1 listed)
- aged more than 18 herpes zoster in cervical, thoracic,lumbar or sacral regions agree to participate to the research
Key exclusion criteria (1 listed)
- 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
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
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.
2 secondary outcomes
To compare the volume and fractional anisotropy of sympathetic ganglion between lesion dermatomes and contralateral dermatomes.
Time frame: 1 year
To compare the volume and fractional anisotropy of DRG between lesion dermatomes and adjacent dermatomes.
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2022.
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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.
Xianwei Zhang, Doctor principal investigator
Huazhong University of Science and Technology
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 Pain and Neuropathy;Peripheral, run by Huazhong University of Science and Technology at 1 site in China.
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 1 inclusion and 1 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 4 Oct 2022. 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 China. 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?
Contact Xianwei Zhang, Doctor ((+86)13037154560, znpain@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To compare the volume and fractional anisotropy of DRG between lesion dermatomes and contralateral dermatomes (time frame: 1 year). 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 Oct 2022.