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

Neuropathic Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04125576
• Other study ID #: HangangSHH-5
• Status: Recruiting
• Start date: October 25, 2019
• Est. completion date: December 20, 2019

Study information

• Verified date: October 2019
• Source: Hangang Sacred Heart Hospital
• Contact: Cheong Hoon Seo, Dr.
• Phone: +82 2 2639 5738
• Email: chseomd[@]gmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 20, 2019
• Est. primary completion date: December 15, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Neuralgia
• Neuropathic Pain

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Hangang Sacred Heart Hospital	Seoul	Yeong-deungpo-Dong

Sponsors (2)

Lead Sponsor	Collaborator
Hangang Sacred Heart Hospital	National Research Foundation of Korea

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	cerebral blood volume	magnetic resonance imaging(MRI) was used to evaluate cerebral blood volume(CBV) of pain network	1 week
Secondary	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