Spatially Transcriptomics Reveals Molecular Signatures in CRPS

Complex Regional Pain Syndromes Clinical Trial

Official title:

Spatially Resolved Transcriptomics Reveals Phenotype-specific Molecular Signatures in Complex Regional Pain Syndrome

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05986461
• Other study ID #: 2304-052-1421
• Status: Recruiting
• Start date: July 18, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: May 2024
• Source: Seoul National University
• Contact: Jee Youn Moon, MD, PhD
• Phone: 82-10-5299-2036
• Email: jymoon0901[@]gmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

This observational study aims to understand phenotype-specific molecular signatures in patients with complex regional pain syndrome (CRPS).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 80 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• Who do not agree to participate in this study

• Who has contraindications for skin punch biopsy (e.g. thrombocytopenia, taking anticoagulant drugs)

Related Conditions & MeSH terms

• Complex Regional Pain Syndromes
• Reflex Sympathetic Dystrophy
• Syndrome

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Seoul National University	Hanyang University

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (7)

Andronic 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. — View Citation

Birklein 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 2 — View Citation

Escolano-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. Epu — View Citation

Ji 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 Comp — View Citation

Rao 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. — View Citation

Stahl 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 an — View Citation

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. Erratum I — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Numerical Rating Scale (NRS)	Intensity of pain (now, weekly avarege, weekly maximum)	At the time of biopsy
Primary	Thermography	Thermography of the involved limb	At the time of diagnosis
Primary	Quantitative Sensory Testing (QST)	Vibration Detection Threshold (VDT), Cold Detection Threshold (CDT)	At the time of diagnosis