Comparison of Pain-Related Changes in Cerebral Blood Volume in Burn Patients With Neuropathic Pain

NCT ID: NCT04125576

Last Updated: 2019-11-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-10-25

Study Completion Date

2019-12-20

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The investigators will observe increased or decreased CBV in patients with thermal injury compared with the CBV in healthy controls.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Prevalence of chronic pain has been shown to be high after thermal injury. Post-burn neuropathic pain causes chronic disabilities that is often difficult to treat effectively.

To study changes in the pain network associated with neuropathic pain, magnetic resonance imaging(MRI) will be used to evaluate cerebral blood volume(CBV) in patients who was injuried by burn. Over the fifty participants will be recruited. The participants will be comprised 30 subjects with neuropathic pain caused by thermal injury and 20 healthy contols. The 30 patients with neuropathic pain will be comprised divided into 15 electrical injury group and 15 non-electrical burn injury group. The patients are included the patients with severe neuropathic pain that is rated at least 5 on the visual analogue scale (VAS), despite treatments with gabapentin medication and other physical modalities. The intensity of neuropathic pain will be measured using the visual analogue scale(VAS). Depressive mood will be assessed using the Beck Depression Scale. CBV maps will be compared between burn patients and controls. And the relationship between individual participant CBV(measured in voxels), BDS and VAS score will be also examined.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Neuropathic Pain

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Burn patients

The subjects complaine of severe neuropathic pain that is rated at least 5 on the visual analogue scale (VAS), despite treatments with gabapentin medication and other physical modalities.

magnetic resonance imaging(MRI)

Intervention Type DIAGNOSTIC_TEST

magnetic resonance imaging(MRI) will be used to evaluate cerebral blood volume(CBV) of pain network

Healthy controls

age and sex matched healthy controls

magnetic resonance imaging(MRI)

Intervention Type DIAGNOSTIC_TEST

magnetic resonance imaging(MRI) will be used to evaluate cerebral blood volume(CBV) of pain network

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

magnetic resonance imaging(MRI)

magnetic resonance imaging(MRI) will be used to evaluate cerebral blood volume(CBV) of pain network

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Burn patients
* severe neuropatic pain rated at least 5 on the 10-point numerical rating scale (NRS).

Exclusion Criteria

* cardiac arrest history
* history of neurologic disease or brain surgery
* unstable heart disease or presence of a cardiac pacemaker
* psychiatric disorder
* diabetes mellitus
* abnormal renal function
* contraindication for MRI
* pregnancy.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Research Foundation of Korea

OTHER

Sponsor Role collaborator

Hangang Sacred Heart Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Hangang Sacred Heart Hospital

Seoul, Yeong-deungpo-Dong, South Korea

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

South Korea

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Cheong Hoon Seo, Dr.

Role: CONTACT

+82 2 2639 5738

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Cheong Hoon Seo, M.D.

Role: primary

+82 2 2639 5738

References

Explore related publications, articles, or registry entries linked to this study.

Park CH, Seo CH, Jung MH, Joo SY, Jang S, Lee HY, Ohn SH. Investigation of cognitive circuits using steady-state cerebral blood volume and diffusion tensor imaging in patients with mild cognitive impairment following electrical injury. Neuroradiology. 2017 Sep;59(9):915-921. doi: 10.1007/s00234-017-1876-1. Epub 2017 Jul 8.

Reference Type BACKGROUND
PMID: 28689261 (View on PubMed)

Seo CH, Park CH, Jung MH, Jang S, Joo SY, Kang Y, Ohn SH. Preliminary Investigation of Pain-Related Changes in Cerebral Blood Volume in Patients With Phantom Limb Pain. Arch Phys Med Rehabil. 2017 Nov;98(11):2206-2212. doi: 10.1016/j.apmr.2017.03.010. Epub 2017 Apr 6.

Reference Type BACKGROUND
PMID: 28392326 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

HangangSHH-5

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Blood Vessel Anatomy and Blood Flow Regulation
NCT05396287 ACTIVE_NOT_RECRUITING