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

• Conditions: Neuropathic Pain
• Interventions: Diagnostic Test: magnetic resonance imaging(MRI)

• Registration Number: NCT04125576
• Lead Sponsor: Hangang Sacred Heart Hospital

Brief Summary

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

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 Timeline

• Status Verified: 2019-10
• Study First Submitted: 2019-10-10
• Study First Submitted QC: 2019-10-10
• Study First Posted: 2019-10-14
• Study Start: 2019-10-25
• Last Update Submitted: 2019-11-13
• Last Update Posted: 2019-11-14
• Primary Completion: 2019-12-15
• Study Completion: 2019-12-20

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Healthy controls	magnetic resonance imaging(MRI)	age and sex matched healthy controls
Burn patients	magnetic resonance imaging(MRI)	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.

Primary Outcome Measures

Name	Time	Method
cerebral blood volume	1 week	magnetic resonance imaging(MRI) was used to evaluate cerebral blood volume(CBV) of pain network

Secondary Outcome Measures

Name	Time	Method
visual analogue scale	1 week	The intensity of neuropathic pain was measured using the visual analogue scale, Zero ("0") represented no pain and 10 represented unbearable symptoms

Trial Locations

Locations (1)

Hangang Sacred Heart Hospital; 🇰🇷 Seoul, Yeong-deungpo-Dong, Korea, Republic of