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RecruitingNCT05523934Updated Jul 27, 2023

Retrospective Analysis of capsaïcin Patch in Complex Regional Pain Syndrome

An observational study in Complex Regional Pain Syndromes, sponsored by Brugmann University Hospital. Recruiting at 1 site in Belgium. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-07-27.

Sponsored by Brugmann University Hospital · Observational

From the registry’s dates

  • Primary completion was expected by Sep 2023, 3 years 1 month ago, but the record still lists the study as recruiting.
  • Started Sep 2022; still recruiting 4 years 1 month later.

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Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
50
Ages
18 Years and older
Sex
All
01

Study summary

Complex regional pain syndrome is a painful syndrome often secondary to a traumatic lesion. Treatment is difficult, of long duration with variable outcomes. Patch of capsaïcin has been proposed as adjuvant to a multimodal treatment. Capsaïcin may act by its effect on transient receptor potential vanilloid 1. Efficacity and outcome studies with this treatment are lacking.

The aim of this retrospective study is to evaluate pain intensity over time assessed by visual analog scale in patient with complex regional pain syndrome treated with capsaïcin patch in addition to their usual treatment.

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; 54 are open to participants now.

This study's planned enrollment of 50 is below the median of 58 across 44 observational studies indexed under Complex Regional Pain Syndromes.

Browse Complex Regional Pain Syndromes studies →

Lead sponsor

Brugmann University Hospital is the lead sponsor of 118 studies on the registry; 17 are open to participants now.

Browse Brugmann University Hospital studies →

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

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Sampling method
Non-probability sample

Study population

All adult patients treated between 2012 and 2022 in the Pain Clinic of the CHU Brugmann for complex regional pain syndrome and who have been treated by a capsaïcin patch in addition to their normal treatment

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

  • Adult patients with complex regional pain syndrome on maximum medical treatment
  • Age ≥18 years
  • Patients treated between 2012 and August 31, 2022 in the pain clinic of the CHU Brugmann

Exclusion criteria

Exclusion Criteria:

  • incomplete medical chart
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
50 participants (estimated)
Patient registry
No

Interventions

  • DrugCapsaïcine patch

    Patients with complex regional pain syndrome under maximal conventional treatment having a supplementary treatment by a capsaïcin patch.

06

What researchers measure

Primary outcomes

  1. Pain intensity

    Pain intensity evaluated by a visual analog scale (on a scale 0 to 10) by patients before and after capsaïcin addition.

    Time frame: 3 month period

07

Study locations

1 of 1 sites recruiting
08

References and documents

Publications

  • Baron R, Fields HL, Janig W, Kitt C, Levine JD. National Institutes of Health Workshop: reflex sympathetic dystrophy/complex regional pain syndromes--state-of-the-science. Anesth Analg. 2002 Dec;95(6):1812-6. doi: 10.1097/00000539-200212000-00064. No abstract available. PubMed 12456464 ↗
  • Birklein F. Complex regional pain syndrome. J Neurol. 2005 Feb;252(2):131-8. doi: 10.1007/s00415-005-0737-8. PubMed 15729516 ↗
  • Geertzen JH, Dijkstra PU, Groothoff JW, ten Duis HJ, Eisma WH. Reflex sympathetic dystrophy of the upper extremity--a 5.5-year follow-up. Part I. Impairments and perceived disability. Acta Orthop Scand Suppl. 1998 Apr;279:12-8. PubMed 9614810 ↗
  • Finnerup NB, Attal N, Haroutounian S, McNicol E, Baron R, Dworkin RH, Gilron I, Haanpaa M, Hansson P, Jensen TS, Kamerman PR, Lund K, Moore A, Raja SN, Rice AS, Rowbotham M, Sena E, Siddall P, Smith BH, Wallace M. Pharmacotherapy for neuropathic pain in adults: a systematic review and meta-analysis. Lancet Neurol. 2015 Feb;14(2):162-73. doi: 10.1016/S1474-4422(14)70251-0. Epub 2015 Jan 7. PubMed 25575710 ↗
  • Steyaert A, Lavand'homme P. Prevention and Treatment of Chronic Postsurgical Pain: A Narrative Review. Drugs. 2018 Mar;78(3):339-354. doi: 10.1007/s40265-018-0866-x. PubMed 29380289 ↗
  • Arora V, Campbell JN, Chung MK. Fight fire with fire: Neurobiology of capsaicin-induced analgesia for chronic pain. Pharmacol Ther. 2021 Apr;220:107743. doi: 10.1016/j.pharmthera.2020.107743. Epub 2020 Nov 10. PubMed 33181192 ↗
  • Simpson DM, Robinson-Papp J, Van J, Stoker M, Jacobs H, Snijder RJ, Schregardus DS, Long SK, Lambourg B, Katz N. Capsaicin 8% Patch in Painful Diabetic Peripheral Neuropathy: A Randomized, Double-Blind, Placebo-Controlled Study. J Pain. 2017 Jan;18(1):42-53. doi: 10.1016/j.jpain.2016.09.008. Epub 2016 Oct 13. PubMed 27746370 ↗
  • Backonja M, Wallace MS, Blonsky ER, Cutler BJ, Malan P Jr, Rauck R, Tobias J; NGX-4010 C116 Study Group. NGX-4010, a high-concentration capsaicin patch, for the treatment of postherpetic neuralgia: a randomised, double-blind study. Lancet Neurol. 2008 Dec;7(12):1106-12. doi: 10.1016/S1474-4422(08)70228-X. Epub 2008 Oct 30. Erratum In: Lancet Neurol. 2009 Jan;8(1):31. PubMed 18977178 ↗
  • Simpson DM, Brown S, Tobias J; NGX-4010 C107 Study Group. Controlled trial of high-concentration capsaicin patch for treatment of painful HIV neuropathy. Neurology. 2008 Jun 10;70(24):2305-13. doi: 10.1212/01.wnl.0000314647.35825.9c. PubMed 18541884 ↗
  • Babbar S, Marier JF, Mouksassi MS, Beliveau M, Vanhove GF, Chanda S, Bley K. Pharmacokinetic analysis of capsaicin after topical administration of a high-concentration capsaicin patch to patients with peripheral neuropathic pain. Ther Drug Monit. 2009 Aug;31(4):502-10. doi: 10.1097/FTD.0b013e3181a8b200. PubMed 19494795 ↗
  • Simpson DM, Gazda S, Brown S, Webster LR, Lu SP, Tobias JK, Vanhove GF; NGX-4010 C118 Study Group. Long-term safety of NGX-4010, a high-concentration capsaicin patch, in patients with peripheral neuropathic pain. J Pain Symptom Manage. 2010 Jun;39(6):1053-64. doi: 10.1016/j.jpainsymman.2009.11.316. PubMed 20538187 ↗
  • Frias B, Merighi A. Capsaicin, Nociception and Pain. Molecules. 2016 Jun 18;21(6):797. doi: 10.3390/molecules21060797. PubMed 27322240 ↗
  • Basith S, Cui M, Hong S, Choi S. Harnessing the Therapeutic Potential of Capsaicin and Its Analogues in Pain and Other Diseases. Molecules. 2016 Jul 23;21(8):966. doi: 10.3390/molecules21080966. PubMed 27455231 ↗
  • Caterina MJ, Leffler A, Malmberg AB, Martin WJ, Trafton J, Petersen-Zeitz KR, Koltzenburg M, Basbaum AI, Julius D. Impaired nociception and pain sensation in mice lacking the capsaicin receptor. Science. 2000 Apr 14;288(5464):306-13. doi: 10.1126/science.288.5464.306. PubMed 10764638 ↗
  • Chen W, Chi YN, Kang XJ, Liu QY, Zhang HL, Li ZH, Zhao ZF, Yang Y, Su L, Cai J, Liao FF, Yi M, Wan Y, Liu FY. Accumulation of Cav3.2 T-type Calcium Channels in the Uninjured Sural Nerve Contributes to Neuropathic Pain in Rats with Spared Nerve Injury. Front Mol Neurosci. 2018 Feb 8;11:24. doi: 10.3389/fnmol.2018.00024. eCollection 2018. PubMed 29472842 ↗
  • Jancso G, Santha P. The foundation of sensory pharmacology: Nicholas (Miklos) Jancso and the Szeged contribution. Temperature (Austin). 2015 May 26;2(2):152-7. doi: 10.1080/23328940.2015.1045683. eCollection 2015 Apr-Jun. PubMed 27227015 ↗
  • Chung MK, Campbell JN. Use of Capsaicin to Treat Pain: Mechanistic and Therapeutic Considerations. Pharmaceuticals (Basel). 2016 Nov 1;9(4):66. doi: 10.3390/ph9040066. PubMed 27809268 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Sep 2022 (actual). Primary completion is estimated for Sep 2023, 12 months after the start.

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

Registered
Aug 29, 2022
First posted
Sep 1, 2022
StartActual
Sep 16, 2022
Primary completionEst.
Sep 30, 2023
CompletionEst.
Oct 30, 2023
Last update
Jul 27, 2023
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 Jul 27, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05523934
Lead sponsor
Brugmann University Hospital
Responsible party
Denis SCHMARTZ (Head of department, anesthesiology, Brugmann University Hospital) — Principal investigator
First posted
Sep 1, 2022
Start date
Sep 16, 2022
Primary completion
Sep 30, 2023 (estimated)
Completion
Oct 30, 2023 (estimated)
Last update
Jul 27, 2023

Study contacts

Denis Schmartz, MD
Contact
denis.schmartz@chu-brugmann.be
+3224773996
Charlie Reynaud, MD
Contact
Charlie.REYNAUD@chu-brugmann.be
+3224773996
Tatiana Besse, MD
study chair · CHU Brugmann

Oversight

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

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