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

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: Neuropathic Pain
• Intervention / Treatment: Diagnostic test: magnetic resonance imaging(MRI)

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

• Study Contact: Name: Cheong Hoon Seo, Dr.; Phone Number: +82 2 2639 5738; Email: chseomd@gmail.com

Study Locations

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

Participation Criteria

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

How is the study designed?

Number of groups / cohorts

2

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	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	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

• Sponsor: Hangang Sacred Heart Hospital
• Collaborators: National Research Foundation of Korea

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

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: neuropathic pain; burn; cerebral blood volume
• Additional Relevant MeSH Terms: Nervous System Diseases; Pain; Neurologic Manifestations; Neuromuscular Diseases; Peripheral Nervous System Diseases; Neuralgia
• 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