AzTrials
AzTrials

Carpal Tunnel Syndrome (CTS)NCT06902831

Comparative Outcomes of Endoscopic and Open Carpal Tunnel Release with Neurotrophic Supplementation in Severe Carpal Tunnel Syndrome

An observational study of Carpal Tunnel Syndrome (CTS), run by University of Bari at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This study addresses the pressing clinical question of optimizing surgical and pharmacological interventions for severe Carpal Tunnel Syndrome (CTS), a prevalent and debilitating condition caused by median nerve compression. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Carpal Tunnel Syndrome (CTS)
What is being tested?
Endoscopic Carpal Tunnel Release, Open carpal tunnel release and Neurotrophic supplementation
Type of treatment
Surgery or procedure
How many people
497 participants
Where
1 siteItaly
Study dates
1 Jun 2022to 1 Apr 2024
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: patients diagnosed with severe Carpal Tunnel Syndrome from Policlinico of Bari

Who may be able to join

  • clinically and electromyographically confirmed severe CTS (SCV < 35 m/s)
  • experienced persistent symptoms unresponsive to conservative treatments for at least six months

Who cannot join

  • mild or moderate CTS
  • concomitant neuropathies
  • previous carpal tunnel surgeries
  • contraindications to neurotrophic supplementation

Trial locations and contacts

1 site in 1 country.

Italy1 site

  • Policlinico di Bari

    Bari, Italy

Other trials in Italy

About this study

This study addresses the pressing clinical question of optimizing surgical and pharmacological interventions for severe Carpal Tunnel Syndrome (CTS), a prevalent and debilitating condition caused by median nerve compression. Previous research has established the efficacy of Open Carpal Tunnel Release (OCTR) and Endoscopic Carpal Tunnel Release (ECTR); however, the role of neurotrophic supplementation in enhancing surgical outcomes has yet to be fully elucidated. Using a prospective clinical approach involving 497 patients, we evaluated the comparative outcomes of ECTR and OCTR with or without neurotrophic supplementation. Key findings demonstrate that ECTR, particularly when combined with neurotrophic agents, facilitates faster recovery and greater improvements in Sensory Nerve Conduction Velocity (VCS) and Visual Analog Scale (VAS) scores, with reduced complication rates compared to OCTR

Being tested
Endoscopic Carpal Tunnel Release, Open carpal tunnel release, Neurotrophic supplementation
Medical subject headings
Carpal Tunnel Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Endoscopic Carpal Tunnel ReleaseProcedure or surgery

    Release of carpal tunnel with endoscopic device

  • Open carpal tunnel releaseProcedure or surgery

    Release of carpal tunnel with open tecnique

  • Neurotrophic supplementationDrug

    Neurotrophic supplementation after surgery

Study groups in NCT06902831
Study groupRoleWhat they receive
Open Carpal Tunnel Release without NeurotrophicNot described
Receives: Procedure: Open carpal tunnel release
Endoscopic Carpal Tunnel Release without NeurotrophicNot described
Receives: Procedure: Endoscopic Carpal Tunnel Release
Open Carpal Tunnel Release with NeurotrophicNot described
Receives: Procedure: Open carpal tunnel release; Drug: Neurotrophic supplementation
Endoscopic Carpal Tunnel Release with NeurotrophicNot described
Receives: Procedure: Endoscopic Carpal Tunnel Release; Drug: Neurotrophic supplementation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. SCV evaluation

    SCV will be evaluated through electomyography after ECTR or OCTR with or without neurotrophic supplementation

    Measured: 12 months of follow-up

  2. VAS for pain evaluation

    VAS for pain will be evaluated through questionnarie after ECTR or OCTR with or without neurotrophic supplementation

    Measured: 12 months of follow-up

  3. VAS for funcionality evaluation

    VAS for functionality will be evaluated through questionnarie after ECTR or OCTR with or without neurotrophic supplementation

    Measured: 12 months of follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Mar 2025
  2. Study start1 Jun 2022
  3. Primary completion1 Apr 2024
  4. Study completion1 Apr 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Prospective
Enrolment
497 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06902831
Sponsor's protocol ID
JHS-S-24-01434
Status last verified
Mar 2025
First submitted
25 Feb 2025
Last updated
30 Mar 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 28205185

  • 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.

    PubMed 38011355

  • 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.

    PubMed 31405030

  • 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.

    PubMed 25177448

  • 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.

    PubMed 34150584

  • 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.

    PubMed 23809470

  • 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.

    PubMed 25135849

  • 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.

    PubMed 23806914

  • 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.

    PubMed 25191172

  • 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.

    PubMed 26441187

  • 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.

    PubMed 32723265

  • 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.

    PubMed 10487914

  • 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.

    PubMed 9583428

  • 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.

    PubMed 11805259

  • 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.

    PubMed 23076750

Questions about this trial

What is this clinical trial studying?

An observational study of Carpal Tunnel Syndrome (CTS), run by University of Bari at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

SCV evaluation (time frame: 12 months of follow-up). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06902831, which also lists 15 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2025; AzTrials last refreshed its copy on 7 Nov 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in