Complex Regional Pain SyndromesNCT05986461
Spatially Transcriptomics Reveals Molecular Signatures in CRPS
An observational study of Complex Regional Pain Syndromes, run by Seoul National University at 1 site in South Korea.
Trial summary
This observational study aims to understand phenotype-specific molecular signatures in patients with complex regional pain syndrome (CRPS). Read more about this study
- Who is it for?
- Ages 19 to 80 years
- Conditions the study is for
- Complex Regional Pain Syndromes
- How many people
- 10 participants
- Where
- 1 siteSouth Korea
- Study dates
- 18 Jul 2023to 31 Dec 2024
- How long will I take part?
- 3 Days
- 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 19 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with CRPS
Who may be able to join
- Meets the Budapest diagnostic criteria
- Consents to participation in this study
- Aged between 19 and 80 years old
- Symptoms and/or signs of sensory, vasomotor, and sudomotor changes
Who cannot join
- Who do not agree to participate in this study
- Who has contraindications for skin punch biopsy (e.g. thrombocytopenia, taking anticoagulant drugs)
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Hospital
Seoul
Jee Youn Moon, M.D., 82-10-5299-2036, jymoon0901@gmail.com
Jee Youn Moon, M.D.
About this study
Official title: Spatially Resolved Transcriptomics Reveals Phenotype-specific Molecular Signatures in Complex Regional Pain Syndrome
This observational study aims to understand phenotype-specific molecular signatures in patients with complex regional pain syndrome (CRPS).
Read the detailed description
Participants who meet the diagnostic criteria for CRPS, aged 19~80 years, and agree to participate in this study will undergo a 4mm-sized skin punch biopsy in the involved limb, as well as the contralateral side (internal control).
Spatial transcriptomics will be used to identify immune cell signatures and differentially regulated genes (DEGs) in the epidermis, vasculature, sweat gland, and nerve plexus of the involved ipsilateral (vs contralateral) side of the patient's skin.
- Conditions
- Complex Regional Pain Syndromes
- Medical subject headings
- Complex Regional Pain Syndromes
What is being measured
The primary outcome is the main question the study is designed to answer.
Numerical Rating Scale (NRS)
Intensity of pain (now, weekly avarege, weekly maximum)
Measured: At the time of biopsy
Thermography
Thermography of the involved limb
Measured: At the time of diagnosis
Quantitative Sensory Testing (QST)
Vibration Detection Threshold (VDT), Cold Detection Threshold (CDT)
Measured: At the time of diagnosis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2023
- Study start18 Jul 2023
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Complex Regional Pain SyndromesStudies 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 10 participants (estimated)
- Target duration
- 3 Days
Sponsor and investigators
- Lead sponsor
- Seoul National University
- Sponsor type
- University, hospital or other
- Collaborators
- Hanyang University
- Responsible party
- Principal investigator, Jeeyoun Moon, Seoul National University
- Investigators
- Jee Youn Moon, MD, PhD, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05986461
- Sponsor's protocol ID
- 2304-052-1421
- Status last verified
- May 2024
- First submitted
- 3 Aug 2023
- Last updated
- 29 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Taylor SS, Noor N, Urits I, Paladini A, Sadhu MS, Gibb C, Carlson T, Myrcik D, Varrassi G, Viswanath O. Complex Regional Pain Syndrome: A Comprehensive Review. Pain Ther. 2021 Dec;10(2):875-892. doi: 10.1007/s40122-021-00279-4. Epub 2021 Jun 24.
PubMed 34165690Rao A, Barkley D, Franca GS, Yanai I. Exploring tissue architecture using spatial transcriptomics. Nature. 2021 Aug;596(7871):211-220. doi: 10.1038/s41586-021-03634-9. Epub 2021 Aug 11.
PubMed 34381231Birklein F, Drummond PD, Li W, Schlereth T, Albrecht N, Finch PM, Dawson LF, Clark JD, Kingery WS. Activation of cutaneous immune responses in complex regional pain syndrome. J Pain. 2014 May;15(5):485-95. doi: 10.1016/j.jpain.2014.01.490. Epub 2014 Jan 23.
PubMed 24462502Escolano-Lozano F, Gries E, Schlereth T, Dimova V, Baka P, Vlckova E, Konig S, Birklein F. Local and Systemic Expression Pattern of MMP-2 and MMP-9 in Complex Regional Pain Syndrome. J Pain. 2021 Oct;22(10):1294-1302. doi: 10.1016/j.jpain.2021.04.002. Epub 2021 Apr 20.
PubMed 33892152Stahl PL, Salmen F, Vickovic S, Lundmark A, Navarro JF, Magnusson J, Giacomello S, Asp M, Westholm JO, Huss M, Mollbrink A, Linnarsson S, Codeluppi S, Borg A, Ponten F, Costea PI, Sahlen P, Mulder J, Bergmann O, Lundeberg J, Frisen J. Visualization and analysis of gene expression in tissue sections by spatial transcriptomics. Science. 2016 Jul 1;353(6294):78-82. doi: 10.1126/science.aaf2403.
PubMed 27365449Ji AL, Rubin AJ, Thrane K, Jiang S, Reynolds DL, Meyers RM, Guo MG, George BM, Mollbrink A, Bergenstrahle J, Larsson L, Bai Y, Zhu B, Bhaduri A, Meyers JM, Rovira-Clave X, Hollmig ST, Aasi SZ, Nolan GP, Lundeberg J, Khavari PA. Multimodal Analysis of Composition and Spatial Architecture in Human Squamous Cell Carcinoma. Cell. 2020 Jul 23;182(2):497-514.e22. doi: 10.1016/j.cell.2020.05.039. Epub 2020 Jun 23.
PubMed 32579974Andronic D, Andronic O, Juengel A, Berli MC, Distler O, Brunner F. Skin biomarkers associated with complex regional pain syndrome (CRPS) Type I: a systematic review. Rheumatol Int. 2022 Jun;42(6):937-947. doi: 10.1007/s00296-021-05061-5. Epub 2022 Jan 8.
PubMed 34997300
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Spatially Resolved Transcriptomics Reveals Phenotype-specific Molecular Signatures in Complex Regional Pain Syndrome
- ClinicalTrials.gov ID
- NCT05986461
- Acronym / sponsor ID
- 2304-052-1421
- Conditions
- Complex Regional Pain Syndromes
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Seoul National UniversityUniversity, hospital or other
- Collaborators
- Hanyang University
- Study start
- 18 Jul 2023 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 14 Aug 2023 (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.
This observational study aims to understand phenotype-specific molecular signatures in patients with complex regional pain syndrome (CRPS).
Detailed description
Participants who meet the diagnostic criteria for CRPS, aged 19~80 years, and agree to participate in this study will undergo a 4mm-sized skin punch biopsy in the involved limb, as well as the contralateral side (internal control).
Spatial transcriptomics will be used to identify immune cell signatures and differentially regulated genes (DEGs) in the epidermis, vasculature, sweat gland, and nerve plexus of the involved ipsilateral (vs contralateral) side of the patient's skin.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Target follow-up
- 3 Days
Who may qualify
- Ages
- 19 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with CRPS
Key inclusion criteria (4 listed)
- Meets the Budapest diagnostic criteria
- Consents to participation in this study
- Aged between 19 and 80 years old
- Symptoms and/or signs of sensory, vasomotor, and sudomotor changes
Key exclusion criteria (2 listed)
- Who do not agree to participate in this study
- Who has contraindications for skin punch biopsy (e.g. thrombocytopenia, taking anticoagulant drugs)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Numerical Rating Scale (NRS)
Time frame: At the time of biopsy
Intensity of pain (now, weekly avarege, weekly maximum)
Thermography
Time frame: At the time of diagnosis
Thermography of the involved limb
Quantitative Sensory Testing (QST)
Time frame: At the time of diagnosis
Vibration Detection Threshold (VDT), Cold Detection Threshold (CDT)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2024.
- Results publication: PubMed 34165690Taylor SS, Noor N, Urits I, Paladini A, Sadhu MS, Gibb C, Carlson T, Myrcik D, Varrassi G, Viswanath O. Complex Regional Pain Syndrome: A Comprehensive Review. Pain Ther. 2021 Dec;10(2):875-892. doi: 10.1007/s40122-021-00279-4. Epub 2021 Jun 24.
- Results publication: PubMed 34381231Rao A, Barkley D, Franca GS, Yanai I. Exploring tissue architecture using spatial transcriptomics. Nature. 2021 Aug;596(7871):211-220. doi: 10.1038/s41586-021-03634-9. Epub 2021 Aug 11.
- Results publication: PubMed 24462502Birklein F, Drummond PD, Li W, Schlereth T, Albrecht N, Finch PM, Dawson LF, Clark JD, Kingery WS. Activation of cutaneous immune responses in complex regional pain syndrome. J Pain. 2014 May;15(5):485-95. doi: 10.1016/j.jpain.2014.01.490. Epub 2014 Jan 23.
- Results publication: PubMed 33892152Escolano-Lozano F, Gries E, Schlereth T, Dimova V, Baka P, Vlckova E, Konig S, Birklein F. Local and Systemic Expression Pattern of MMP-2 and MMP-9 in Complex Regional Pain Syndrome. J Pain. 2021 Oct;22(10):1294-1302. doi: 10.1016/j.jpain.2021.04.002. Epub 2021 Apr 20.
- Results publication: PubMed 27365449Stahl PL, Salmen F, Vickovic S, Lundmark A, Navarro JF, Magnusson J, Giacomello S, Asp M, Westholm JO, Huss M, Mollbrink A, Linnarsson S, Codeluppi S, Borg A, Ponten F, Costea PI, Sahlen P, Mulder J, Bergmann O, Lundeberg J, Frisen J. Visualization and analysis of gene expression in tissue sections by spatial transcriptomics. Science. 2016 Jul 1;353(6294):78-82. doi: 10.1126/science.aaf2403.
- Results publication: PubMed 32579974Ji AL, Rubin AJ, Thrane K, Jiang S, Reynolds DL, Meyers RM, Guo MG, George BM, Mollbrink A, Bergenstrahle J, Larsson L, Bai Y, Zhu B, Bhaduri A, Meyers JM, Rovira-Clave X, Hollmig ST, Aasi SZ, Nolan GP, Lundeberg J, Khavari PA. Multimodal Analysis of Composition and Spatial Architecture in Human Squamous Cell Carcinoma. Cell. 2020 Jul 23;182(2):497-514.e22. doi: 10.1016/j.cell.2020.05.039. Epub 2020 Jun 23.
- Results publication: PubMed 34997300Andronic D, Andronic O, Juengel A, Berli MC, Distler O, Brunner F. Skin biomarkers associated with complex regional pain syndrome (CRPS) Type I: a systematic review. Rheumatol Int. 2022 Jun;42(6):937-947. doi: 10.1007/s00296-021-05061-5. Epub 2022 Jan 8.
- 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.
Jee Youn Moon, MD, PhD principal investigator
Seoul National University Hospital
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 Complex Regional Pain Syndromes, run by Seoul National University 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 4 inclusion and 2 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 29 May 2024. 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 Jee Youn Moon, MD, PhD (82-10-5299-2036, jymoon0901@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numerical Rating Scale (NRS) (time frame: At the time of biopsy). The study lists 3 primary outcomes in all. 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 NCT05986461, which also lists 7 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 29 May 2024.