Neuropathic PainNCT04125576
Comparison of Pain-Related Changes in Cerebral Blood Volume in Burn Patients With Neuropathic Pain
An observational study of Neuropathic Pain, run by Hangang Sacred Heart Hospital at 1 site in South Korea.
Trial summary
The investigators will observe increased or decreased CBV in patients with thermal injury compared with the CBV in healthy controls. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Neuropathic Pain
- What is being tested?
- magnetic resonance imaging(MRI)
- How many people
- 50 participants
- Where
- 1 siteSouth Korea
- Study dates
- 25 Oct 2019to 20 Dec 2019
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- Burn patients
- severe neuropatic pain rated at least 5 on the 10-point numerical rating scale (NRS).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Hangang Sacred Heart Hospital
Seoul, Yeong-deungpo-Dong, 150-719
Cheong Hoon Seo, M.D., +82 2 2639 5738, chseomd@gmail.com
About this study
The investigators will observe increased or decreased CBV in patients with thermal injury compared with the CBV in healthy controls.
Read the 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.
- Conditions
- Neuropathic Pain
- Being tested
- magnetic resonance imaging(MRI)
- Keywords
- burn, neuropathic pain, cerebral blood volume
- Medical subject headings
- Neuralgia, Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
magnetic resonance imaging(MRI)Diagnostic test
magnetic resonance imaging(MRI) will be used to evaluate cerebral blood volume(CBV) of pain network
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: magnetic resonance imaging(MRI) | |
| Healthy controls | age and sex matched healthy controls Receives: Diagnostic Test: magnetic resonance imaging(MRI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
cerebral blood volume
magnetic resonance imaging(MRI) was used to evaluate cerebral blood volume(CBV) of pain network
Measured: 1 week
Secondary outcomes (1)
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
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2019
- Study start25 Oct 2019
- Primary completion15 Dec 2019 (estimated)
- Study completion20 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Neuropathic PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Hangang Sacred Heart Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Research Foundation of Korea
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04125576
- Sponsor's protocol ID
- HangangSHH-5
- Status last verified
- Oct 2019
- First submitted
- 10 Oct 2019
- Last updated
- 14 Nov 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 28689261Seo 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.
PubMed 28392326
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Pain-Related Changes in Cerebral Blood Volume in Burn Patients With Neuropathic Pain
- ClinicalTrials.gov ID
- NCT04125576
- Acronym / sponsor ID
- HangangSHH-5
- Conditions
- Neuropathic Pain
- Keywords
- burn, neuropathic pain, cerebral blood volume
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Hangang Sacred Heart HospitalUniversity, hospital or other
- Collaborators
- National Research Foundation of Korea
- Study start
- 25 Oct 2019 (actual)
- Primary completion
- 15 Dec 2019 (estimated)
- Study completion
- 20 Dec 2019 (estimated)
- First posted
- 14 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Burn patients | – | Diagnostic Test: 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. |
| Healthy controls | – | Diagnostic Test: magnetic resonance imaging(MRI)age and sex matched healthy controls |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (2 listed)
- Burn patients
- severe neuropatic pain rated at least 5 on the 10-point numerical rating scale (NRS).
Key exclusion criteria (8 listed)
- cardiac arrest history
- history of neurologic disease or brain surgery
- unstable heart disease or presence of a cardiac pacemaker
- psychiatric disorder
- diabetes mellitus
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| magnetic resonance imaging(MRI)magnetic resonance imaging(MRI) will be used to evaluate cerebral blood volume(CBV) of pain network | Diagnostic test | Burn patients, Healthy controls |
Primary outcome
cerebral blood volume
Time frame: 1 week
magnetic resonance imaging(MRI) was used to evaluate cerebral blood volume(CBV) of pain network
1 secondary outcome
visual analogue scale
Time frame: 1 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2019.
- Background: PubMed 28689261Park 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.
- Background: PubMed 28392326Seo 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neuropathic Pain, run by Hangang Sacred Heart Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Cheong Hoon Seo, Dr. (+82 2 2639 5738, chseomd@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cerebral blood volume (time frame: 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04125576, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2019.