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Carpal Tunnel Syndrome (CTS)NCT07364604

Very Early Outcomes in Endoscopic Versus Open Carpal Tunnel Release

An observational study of Carpal Tunnel Syndrome (CTS), run by Stanford University at 1 site in United States.

Completed

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

Official record
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Trial summary

We are looking at whether there is a difference in pain and function in the very early period when comparing carpal tunnel release performed by the endoscopic technique versus the open technique. 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?
Carpal Tunnel Release
Type of treatment
Surgery or procedure
How many people
113 participants
Where
1 siteUnited States
Study dates
1 Mar 2022to 30 Jun 2024
How long will I take part?
2 Weeks
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 18 years of age or older, diagnosed with carpal tunnel syndrome and indicated to undergo carpal tunnel release with one of the three participating hand surgeons. Carpal tunnel syndrome was diagnosed using the physical exam, including two-point discrimination, Phalen's test, Durkan's nerve compression test, and Tinel's sign in all study participants. All patients included in the study demonstrated a CTS-6 score over 12. An electromyography (EMG) of the median nerve was performed when determined to be necessary by either the treating surgeon or referring physician.

Who may be able to join

  • Patients 18 years of age or older
  • Diagnosed with carpal tunnel syndrome and indicated to undergo carpal tunnel release with one of the three participating hand surgeons were included in this study.

Who cannot join

  • Patients younger than 18 years old
  • Pregnant women
  • Revision carpal tunnel surgery, or patients who underwent any other type of surgery concomitantly with the carpal tunnel release.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Stanford University

    Palo Alto, California, 93405

Other trials in United States

About this study

We are looking at whether there is a difference in pain and function in the very early period when comparing carpal tunnel release performed by the endoscopic technique versus the open technique.

Read the detailed description

The purpose of our study is to examine the very early (<2 weeks post-op) outcomes of endoscopic versus open carpal tunnel releases (CTR). We will call patients on post-operative days 3, 7 and 14 and collect Single Assessment Numeric Evaluation (SANE), Patient Related Wrist and Hand Evaluation (PRWHE), Visual Analog Scale (VAS) pain and return to work status at each time frame to see if there is any difference between the two procedures.

Being tested
Carpal Tunnel Release
Keywords
Endoscopic carpal tunnel release, Open carpal tunnel release
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.

  • Carpal Tunnel ReleaseProcedure or surgery

    Description: An open incision was made over the proximal palm to access and visualize transverse carpal tunnel, then divided it completely surgically. In the endoscopic technique, a small incision is made over the distal wrist and a camera and blade are within the wrist, then the transverse carpal ligament is divide from inside the palm

Study groups in NCT07364604
Study groupRoleWhat they receive
Endoscopic Carpal Tunnel ReleasePatients who underwent endoscopic carpal tunnel release
Receives: Procedure: Carpal Tunnel Release
Open Carpal Tunnel ReleasePatients who underwent open carpal tunnel release
Receives: Procedure: Carpal Tunnel Release

What is being measured

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

  1. Post-operative pain

    This was evaluated by administering the Patient Related Wrist and Hand Evaluation (PRWHE) questionnaire as well as obtaining a pain score using the Visual Analog Scale (VAS).

    Measured: This was assessed at post-operative days 3, 7, and 14

  2. Function

    Patients were first asked to assess the function of their operative hand and wrist using the Single Assessment Numeric Evaluation (SANE) tool. Function was also assessed by administering the Patient Related Wrist and Hand Evaluation (PRWHE) questionnaire.

    Measured: Function was assessed at post-operative days 3, 7 and 14.

Secondary outcomes (1)

  1. Return to Work Status

    Of those study patients who were not retired, we assessed if and when patients returned to work.

    Measured: Return to work status was assessed at post-operative days 3, 7, and 14.

Timeline

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

  1. First posted23 Jan 2026
  2. Study start1 Mar 2022
  3. Primary completion30 Jun 2024
  4. Study completion30 Jun 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
Cohort
Time perspective
Prospective
Enrolment
113 participants (actual)
Target duration
2 Weeks
IDs, dates and publications
ClinicalTrials.gov ID
NCT07364604
Sponsor's protocol ID
64461
Status last verified
Jan 2026
First submitted
16 Jan 2026
Last updated
23 Jan 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Mehta SP, MacDermid JC, Richardson J, MacIntyre NJ, Grewal R. A systematic review of the measurement properties of the patient-rated wrist evaluation. J Orthop Sports Phys Ther. 2015 Apr;45(4):289-98. doi: 10.2519/jospt.2015.5236.

    PubMed 25827124

  • Gire JD, Koltsov JCB, Segovia NA, Kenney DE, Yao J, Ladd AL. Single Assessment Numeric Evaluation (SANE) in Hand Surgery: Does a One-Question Outcome Instrument Compare Favorably? J Hand Surg Am. 2020 Jul;45(7):589-596. doi: 10.1016/j.jhsa.2020.03.024. Epub 2020 May 29.

    PubMed 32482496

  • Kishan A, Kubsad S, Haft M, Fox HM, Tuffaha SH, LaPorte DM, Nguyen DM. Endoscopic Versus Open Treatment of Carpal Tunnel Syndrome: Postoperative Complications in Patients With Diabetes Mellitus. J Hand Surg Glob Online. 2024 Jun 12;6(4):577-582. doi: 10.1016/j.jhsg.2024.04.015. eCollection 2024 Jul.

    PubMed 39166198

  • Li Y, Luo W, Wu G, Cui S, Zhang Z, Gu X. Open versus endoscopic carpal tunnel release: a systematic review and meta-analysis of randomized controlled trials. BMC Musculoskelet Disord. 2020 Apr 27;21(1):272. doi: 10.1186/s12891-020-03306-1.

    PubMed 32340621

  • Ilyas AM, Miller AJ, Graham JG, Matzon JL. Pain Management After Carpal Tunnel Release Surgery: A Prospective Randomized Double-Blinded Trial Comparing Acetaminophen, Ibuprofen, and Oxycodone. J Hand Surg Am. 2018 Oct;43(10):913-919. doi: 10.1016/j.jhsa.2018.08.011.

    PubMed 30286851

  • 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

  • Atroshi I, Larsson GU, Ornstein E, Hofer M, Johnsson R, Ranstam J. Outcomes of endoscopic surgery compared with open surgery for carpal tunnel syndrome among employed patients: randomised controlled trial. BMJ. 2006 Jun 24;332(7556):1473. doi: 10.1136/bmj.38863.632789.1F. Epub 2006 Jun 15.

    PubMed 16777857

  • Saw NL, Jones S, Shepstone L, Meyer M, Chapman PG, Logan AM. Early outcome and cost-effectiveness of endoscopic versus open carpal tunnel release: a randomized prospective trial. J Hand Surg Br. 2003 Oct;28(5):444-9. doi: 10.1016/s0266-7681(03)00097-4.

    PubMed 12954254

  • Chen L, Duan X, Huang X, Lv J, Peng K, Xiang Z. Effectiveness and safety of endoscopic versus open carpal tunnel decompression. Arch Orthop Trauma Surg. 2014 Apr;134(4):585-93. doi: 10.1007/s00402-013-1898-z. Epub 2014 Jan 12.

    PubMed 24414237

  • Aslani HR, Alizadeh K, Eajazi A, Karimi A, Karimi MH, Zaferani Z, Hosseini Khameneh SM. Comparison of carpal tunnel release with three different techniques. Clin Neurol Neurosurg. 2012 Sep;114(7):965-8. doi: 10.1016/j.clineuro.2012.02.017. Epub 2012 Mar 14.

    PubMed 22421246

  • Miles MR, Shetty PN, Bhayana K, Yousaf IS, Sanghavi KK, Giladi AM. Early Outcomes of Endoscopic Versus Open Carpal Tunnel Release. J Hand Surg Am. 2021 Oct;46(10):868-876. doi: 10.1016/j.jhsa.2021.04.030. Epub 2021 May 25.

    PubMed 34049728

  • Macdermid JC, Richards RS, Roth JH, Ross DC, King GJ. Endoscopic versus open carpal tunnel release: a randomized trial. J Hand Surg Am. 2003 May;28(3):475-80. doi: 10.1053/jhsu.2003.50080.

    PubMed 12772108

  • Agee JM, McCarroll HR Jr, Tortosa RD, Berry DA, Szabo RM, Peimer CA. Endoscopic release of the carpal tunnel: a randomized prospective multicenter study. J Hand Surg Am. 1992 Nov;17(6):987-95. doi: 10.1016/s0363-5023(09)91044-9.

    PubMed 1430964

  • Graham B. The value added by electrodiagnostic testing in the diagnosis of carpal tunnel syndrome. J Bone Joint Surg Am. 2008 Dec;90(12):2587-93. doi: 10.2106/JBJS.G.01362.

    PubMed 19047703

  • Williamson ERC, Vasquez Montes D, Melamed E. Multistate Comparison of Cost, Trends, and Complications in Open Versus Endoscopic Carpal Tunnel Release. Hand (N Y). 2021 Jan;16(1):25-31. doi: 10.1177/1558944719837020. Epub 2019 Mar 29.

    PubMed 30924367

Questions about this trial

What is this clinical trial studying?

An observational study of Carpal Tunnel Syndrome (CTS), run by Stanford University at 1 site in United States.

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 3 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 23 Jan 2026. 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 United States. 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?

Post-operative pain (time frame: This was assessed at post-operative days 3, 7, and 14). The study lists 2 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 NCT07364604, which also lists 21 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 23 Jan 2026.

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