- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05523934
Retrospective Analysis of capsaïcin Patch in Complex Regional Pain Syndrome
Capsaïcin patch8% in Adult Complex Regional Pain Syndromes: a Retrospective Analysis
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Charlie Reynaud, MD
- Phone Number: +3224773996
- Email: Charlie.REYNAUD@chu-brugmann.be
Study Contact Backup
- Name: Denis Schmartz, MD
- Phone Number: +3224773996
- Email: denis.schmartz@chu-brugmann.be
Study Locations
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-
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Brussels, Belgium, 1020
- Recruiting
- CHU Brugmann
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Contact:
- Denis Schmartz, MD
- Phone Number: +3224773996
- Email: denis.schmartz@chu-brugmann.be
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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:
- incomplete medical chart
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Retrospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain intensity
Time Frame: 3 month period
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Pain intensity evaluated by a visual analog scale (on a scale 0 to 10) by patients before and after capsaïcin addition.
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3 month period
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Tatiana Besse, MD, CHU Brugmann
Publications and helpful links
General Publications
- 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.
- 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.
- Birklein F. Complex regional pain syndrome. J Neurol. 2005 Feb;252(2):131-8. doi: 10.1007/s00415-005-0737-8.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- Frias B, Merighi A. Capsaicin, Nociception and Pain. Molecules. 2016 Jun 18;21(6):797. doi: 10.3390/molecules21060797.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Pathologic Processes
- Nervous System Diseases
- Disease
- Neuromuscular Diseases
- Peripheral Nervous System Diseases
- Autonomic Nervous System Diseases
- Syndrome
- Complex Regional Pain Syndromes
- Reflex Sympathetic Dystrophy
- Somatoform Disorders
- Physiological Effects of Drugs
- Peripheral Nervous System Agents
- Sensory System Agents
- Dermatologic Agents
- Antipruritics
- Capsaicin
Other Study ID Numbers
- patch_CRPS-retro
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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