Comparative Outcomes of Endoscopic and Open Carpal Tunnel Release with Neurotrophic Supplementation in Severe Carpal Tunnel Syndrome
NCT ID: NCT06902831
Last Updated: 2025-03-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
497 participants
OBSERVATIONAL
2022-06-01
2024-04-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Open Carpal Tunnel Release without Neurotrophic
Open carpal tunnel release
Release of carpal tunnel with open tecnique
Endoscopic Carpal Tunnel Release without Neurotrophic
Endoscopic Carpal Tunnel Release
Release of carpal tunnel with endoscopic device
Open Carpal Tunnel Release with Neurotrophic
Open carpal tunnel release
Release of carpal tunnel with open tecnique
Neurotrophic supplementation
Neurotrophic supplementation after surgery
Endoscopic Carpal Tunnel Release with Neurotrophic
Endoscopic Carpal Tunnel Release
Release of carpal tunnel with endoscopic device
Neurotrophic supplementation
Neurotrophic supplementation after surgery
Interventions
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Endoscopic Carpal Tunnel Release
Release of carpal tunnel with endoscopic device
Open carpal tunnel release
Release of carpal tunnel with open tecnique
Neurotrophic supplementation
Neurotrophic supplementation after surgery
Eligibility Criteria
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Inclusion Criteria
* experienced persistent symptoms unresponsive to conservative treatments for at least six months
Exclusion Criteria
* concomitant neuropathies
* previous carpal tunnel surgeries
* contraindications to neurotrophic supplementation
18 Years
ALL
No
Sponsors
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University of Bari
OTHER
Responsible Party
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Rossella Elia, MD PhD
Prof. Rosella Elia
Locations
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Policlinico di Bari
Bari, Italy, Italy
Countries
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References
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Desideri I, Francolini G, Becherini C, Terziani F, Delli Paoli C, Olmetto E, Loi M, Perna M, Meattini I, Scotti V, Greto D, Bonomo P, Sulprizio S, Livi L. Use of an alpha lipoic, methylsulfonylmethane and bromelain dietary supplement (Opera(R)) for chemotherapy-induced peripheral neuropathy management, a prospective study. Med Oncol. 2017 Mar;34(3):46. doi: 10.1007/s12032-017-0907-4. Epub 2017 Feb 15.
Nikbakht S, Vafaei MA, Ashraf A, Nasiri A, Nikpay-Hosseinabad N. Assessment of L-carnitine effectiveness on carpal tunnel syndrome. Curr J Neurol. 2022 Jul 6;21(3):162-169. doi: 10.18502/cjn.v21i3.11109.
Salehi B, Berkay Yilmaz Y, Antika G, Boyunegmez Tumer T, Fawzi Mahomoodally M, Lobine D, Akram M, Riaz M, Capanoglu E, Sharopov F, Martins N, Cho WC, Sharifi-Rad J. Insights on the Use of alpha-Lipoic Acid for Therapeutic Purposes. Biomolecules. 2019 Aug 9;9(8):356. doi: 10.3390/biom9080356.
Kim PT, Lee HJ, Kim TG, Jeon IH. Current approaches for carpal tunnel syndrome. Clin Orthop Surg. 2014 Sep;6(3):253-7. doi: 10.4055/cios.2014.6.3.253. Epub 2014 Aug 5.
Orhurhu V, Orman S, Peck J, Urits I, Orhurhu MS, Jones MR, Manchikanti L, Kaye AD, Odonkor C, Hirji S, Cornett EM, Imani F, Varrassi G, Viswanath O. Carpal Tunnel Release Surgery- A Systematic Review of Open and Endoscopic Approaches. Anesth Pain Med. 2020 Dec 26;10(6):e112291. doi: 10.5812/aapm.112291. eCollection 2020 Dec.
Zieske L, Ebersole GC, Davidge K, Fox I, Mackinnon SE. Revision carpal tunnel surgery: a 10-year review of intraoperative findings and outcomes. J Hand Surg Am. 2013 Aug;38(8):1530-9. doi: 10.1016/j.jhsa.2013.04.024. Epub 2013 Jun 25.
Sayegh ET, Strauch RJ. Open versus endoscopic carpal tunnel release: a meta-analysis of randomized controlled trials. Clin Orthop Relat Res. 2015 Mar;473(3):1120-32. doi: 10.1007/s11999-014-3835-z. Epub 2014 Aug 19.
Soltani AM, Allan BJ, Best MJ, Mir HS, Panthaki ZJ. A systematic review of the literature on the outcomes of treatment for recurrent and persistent carpal tunnel syndrome. Plast Reconstr Surg. 2013 Jul;132(1):114-121. doi: 10.1097/PRS.0b013e318290faba.
Means KR Jr, Dubin NH, Patel KM, Pletka JD. Long-term outcomes following single-portal endoscopic carpal tunnel release. Hand (N Y). 2014 Sep;9(3):384-8. doi: 10.1007/s11552-014-9614-1.
Atroshi I, Hofer M, Larsson GU, Ranstam J. Extended Follow-up of a Randomized Clinical Trial of Open vs Endoscopic Release Surgery for Carpal Tunnel Syndrome. JAMA. 2015 Oct 6;314(13):1399-401. doi: 10.1001/jama.2015.12208. No abstract available.
Marvulli R, Ianieri G, De Venuto G, Falcicchio M, Gallo GA, Mennuni C, Gallone MF, Fiore P, Ranieri M, Megna M. Electrophysiological and Clinical Improvement in Non-Invasive Treatment of Carpal Tunnel Syndrome. Endocr Metab Immune Disord Drug Targets. 2021;21(2):345-351. doi: 10.2174/1871530320666200728152953.
Stevens JC, Smith BE, Weaver AL, Bosch EP, Deen HG Jr, Wilkens JA. Symptoms of 100 patients with electromyographically verified carpal tunnel syndrome. Muscle Nerve. 1999 Oct;22(10):1448-56. doi: 10.1002/(sici)1097-4598(199910)22:103.0.co;2-y.
Nordstrom DL, DeStefano F, Vierkant RA, Layde PM. Incidence of diagnosed carpal tunnel syndrome in a general population. Epidemiology. 1998 May;9(3):342-5.
Mondelli M, Giannini F, Giacchi M. Carpal tunnel syndrome incidence in a general population. Neurology. 2002 Jan 22;58(2):289-94. doi: 10.1212/wnl.58.2.289.
Spahn G, Wollny J, Hartmann B, Schiele R, Hofmann GO. [Metaanalysis for the evaluation of risk factors for carpal tunnel syndrome (CTS) Part II. Occupational risk factors]. Z Orthop Unfall. 2012 Oct;150(5):516-24. doi: 10.1055/s-0032-1315346. Epub 2012 Oct 17. German.
Other Identifiers
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JHS-S-24-01434
Identifier Type: -
Identifier Source: org_study_id
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