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

November 13, 2019 updated by: Hangang Sacred Heart Hospital
The investigators will observe increased or decreased CBV in patients with thermal injury compared with the CBV in healthy controls.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Anticipated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Yeong-deungpo-Dong
      • Seoul, Yeong-deungpo-Dong, Korea, Republic of, 150-719
        • Recruiting
        • Hangang Sacred Heart Hospital

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 to 60 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The patients complained of severe neuropatic pain rated at least 5 on the 10-point numerical rating scale (NRS), despite being treated with drugs and physical therapy for more than 1 week after being admitted to the Department of Rehabilitation Medicine.

Description

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.

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Diagnostic test: magnetic resonance imaging(MRI)
magnetic resonance imaging(MRI) will be used to evaluate cerebral blood volume(CBV) of pain network
Healthy controls
age and sex matched healthy controls
Diagnostic test: magnetic resonance imaging(MRI)
magnetic resonance imaging(MRI) will be used to evaluate cerebral blood volume(CBV) of pain network

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
cerebral blood volume
Time Frame: 1 week
magnetic resonance imaging(MRI) was used to evaluate cerebral blood volume(CBV) of pain network
1 week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
visual analogue scale
Time Frame: 1 week
The intensity of neuropathic pain was measured using the visual analogue scale, Zero ("0") represented no pain and 10 represented unbearable symptoms
1 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hangang Sacred Heart Hospital

Collaborators

National Research Foundation of Korea

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

October 25, 2019

Primary Completion (ANTICIPATED)

December 15, 2019

Study Completion (ANTICIPATED)

December 20, 2019

Study Registration Dates

First Submitted

October 10, 2019

First Submitted That Met QC Criteria

October 10, 2019

First Posted (ACTUAL)

October 14, 2019

Study Record Updates

Last Update Posted (ACTUAL)

November 14, 2019

Last Update Submitted That Met QC Criteria

November 13, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HangangSHH-5

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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