ClinicalTrials.gg
RecruitingNCT05986461Updated May 29, 2024

Spatially Transcriptomics Reveals Molecular Signatures in CRPS

An observational study in Complex Regional Pain Syndromes, sponsored by Seoul National University. Recruiting at 1 site in Korea, Republic of. Open to participants aged 19 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-05-29.

Sponsored by Seoul National University · Observational

From the registry’s dates

  • Primary completion was expected by Dec 2024, 1 year 10 months ago, but the record still lists the study as recruiting.
  • Started Jul 2023; still recruiting 3 years 3 months later.

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Study type
Observational
Model
Case-only
Time perspective
Cross-sectional
Enrollment
10
Ages
19 Years to 80 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Complex Regional Pain Syndromes
03

In context

Complex Regional Pain Syndromes

206 studies on the registry are indexed under Complex Regional Pain Syndromes; 55 are open to participants now.

This study's planned enrollment of 10 is below the median of 58 across 44 observational studies indexed under Complex Regional Pain Syndromes.

Browse Complex Regional Pain Syndromes studies →

Lead sponsor

Seoul National University is the lead sponsor of 32 studies on the registry; 10 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients with CRPS

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Who do not agree to participate in this study
  • Who has for skin punch (e.g. thrombocytopenia, taking anticoagulant drugs)
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

Biopsy and archival tissue

A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.

Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.

05

Study design

Observational model
Case-only
Time perspective
Cross-sectional
Enrollment
10 participants (estimated)
Target follow-up
3 Days
Patient registry
Yes
Biospecimen retention
Samples with dna
06

What researchers measure

Primary outcomes

  1. Numerical Rating Scale (NRS)

    Intensity of pain (now, weekly avarege, weekly maximum)

    Time frame: At the time of biopsy

  2. Thermography

    Thermography of the involved limb

    Time frame: At the time of diagnosis

  3. Quantitative Sensory Testing (QST)

    Vibration Detection Threshold (VDT), Cold Detection Threshold (CDT)

    Time frame: At the time of diagnosis

07

Study locations

1 of 1 sites recruiting
08

References and documents

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. Erratum In: Pain Ther. 2021 Dec;10(2):893-894. doi: 10.1007/s40122-021-00291-8. PubMed 34165690 ↗
  • 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. PubMed 34381231 ↗
  • 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. PubMed 24462502 ↗
  • 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. Epub 2021 Apr 20. PubMed 33892152 ↗
  • 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 analysis of gene expression in tissue sections by spatial transcriptomics. Science. 2016 Jul 1;353(6294):78-82. doi: 10.1126/science.aaf2403. PubMed 27365449 ↗
  • 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. Erratum In: Cell. 2020 Sep 17;182(6):1661-1662. doi: 10.1016/j.cell.2020.08.043. PubMed 32579974 ↗
  • 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. PubMed 34997300 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Jul 2023 (actual). Primary completion is estimated for Dec 2024, 17 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 3, 2023
First posted
Aug 14, 2023
StartActual
Jul 18, 2023
Primary completionEst.
Dec 31, 2024
CompletionEst.
Dec 31, 2024
Last update
May 29, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 29, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05986461
Lead sponsor
Seoul National University
Collaborators
Hanyang University
Responsible party
Jeeyoun Moon (Professor, Seoul National University) — Principal investigator
First posted
Aug 14, 2023
Start date
Jul 18, 2023
Primary completion
Dec 31, 2024 (estimated)
Completion
Dec 31, 2024 (estimated)
Last update
May 29, 2024

Study contacts

Jee Youn Moon, MD, PhD
Contact
jymoon0901@gmail.com
82-10-5299-2036
Jeongsoo Kim, MD
Contact
dreamsu457@gmail.com
82-10-4734-6422
Jee Youn Moon, MD, PhD
principal investigator · Seoul National University Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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