Clinical trial NCT05986461: Spatially Transcriptomics Reveals Molecular Signatures in CRPS
Official title: Spatially Resolved Transcriptomics Reveals Phenotype-specific Molecular Signatures in Complex Regional Pain Syndrome
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Complex Regional Pain Syndromes
Lead sponsor: Seoul National University
Sponsor class: OTHER
Collaborators: name: Hanyang University
First posted: 2023-08-14
Enrollment: 10
Sex: ALL
Minimum age (years): 19
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with CRPS

Brief summary: 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Numerical Rating Scale (NRS)
timeFrame: At the time of biopsy
measure: Thermography
timeFrame: At the time of diagnosis
measure: Quantitative Sensory Testing (QST)
timeFrame: At the time of diagnosis
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Jee Youn Moon, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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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 23.
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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 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.
citation: 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.