Comparison of Two Techniques for the Treatment of Carpal Tunnel Syndrome

NCT05468814 | Completed Results DMC

• 1 other identifier: STCOT
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

The main objective of this study is to compare the complete section of the transverse carpal ligament with another median nerve release technique and to determine if the incidence of post-surgical pillar pain is lower for either of the two surgical techniques. As secondary objectives, we also seek to determine if the postsurgical grip and pincer strength and the Boston Carpal Tunnel Questionnaire (BCTQ) score are better for either of the two surgical techniques.

Conditions

Carpal Tunnel Syndrome

Keywords

Carpal Tunnel Syndrome; Pillar pain; Grip strength; Pincer strength

Outcome Measures

Primary Outcomes (2)

• Incidence of Pillar Pain

  Pain/allodynia in the area of the thenar and/or hypothenar eminences, scar hyperalgesia, pain when supporting the heel of the hand, dysesthesia

  3 weeks after surgery

• Incidence of Pillar Pain

  Pain/allodynia in the area of the thenar and/or hypothenar eminences, scar hyperalgesia, pain when supporting the heel of the hand, dysesthesia

  6 months after surgery

Secondary Outcomes (8)

• Grip Strength

  3 weeks after surgery

• Grip Strength

  6 months

• Pinch Strength

  3 weeks

• Pinch Strength

  6 months

• Clinical BCTQ

  3 weeks after surgery

Study Arms (2)

Z-plasty

EXPERIMENTAL

It is a surgical technique in which a Z-shaped section of the transverse carpal ligament is performed, to later join both ends with a resorbable stitch.

Procedure: Z-plasty

Conventional

ACTIVE COMPARATOR

It is a surgical technique in which a complete section of the transverse carpal ligament is performed, without subsequent closure.

Procedure: Conventional

Interventions

Z-plasty PROCEDURE

It is a surgical technique in which a Z-shaped section of the transverse carpal ligament is performed, to later join both ends with a resorbable stitch.

Z-plasty

Conventional PROCEDURE

It is a surgical technique in which a complete section of the transverse carpal ligament is performed, without subsequent closure.

Conventional

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \> 18 years
• Moderate-severe carpal tunnel syndrome
• Symptoms that hinder the patient's daily activities
• Correct conservative treatment without success

You may not qualify if:

• Previous surgical intervention for carpal tunnel syndrome
• Traumatic or congenital sequelae of the hand
• Incompetence to understand the process and the tests to be carried out

Sponsors & Collaborators

• Hospital Universitario Reina Sofia de Cordoba: lead

Study Sites (1)

Hospital Universitario Reina Sofia

Córdoba, 14004, Spain

Location

Related Publications (22)

• Genova A, Dix O, Saefan A, Thakur M, Hassan A. Carpal Tunnel Syndrome: A Review of Literature. Cureus. 2020 Mar 19;12(3):e7333. doi: 10.7759/cureus.7333.

  PMID: 32313774 BACKGROUND

• Ludlow KS, Merla JL, Cox JA, Hurst LN. Pillar pain as a postoperative complication of carpal tunnel release: a review of the literature. J Hand Ther. 1997 Oct-Dec;10(4):277-82. doi: 10.1016/s0894-1130(97)80042-7.

  PMID: 9399176 BACKGROUND

• Murthy PG, Goljan P, Mendez G, Jacoby SM, Shin EK, Osterman AL. Mini-open versus extended open release for severe carpal tunnel syndrome. Hand (N Y). 2015 Mar;10(1):34-9. doi: 10.1007/s11552-014-9650-x.

  PMID: 25767419 BACKGROUND

• Bai J, Kong L, Zhao H, Yu K, Zhang B, Zhang J, Tian D. Carpal tunnel release with a new mini-incision approach versus a conventional approach, a retrospective cohort study. Int J Surg. 2018 Apr;52:105-109. doi: 10.1016/j.ijsu.2018.02.033. Epub 2018 Feb 20.

  PMID: 29471152 BACKGROUND

• Khoshnevis J, Layegh H, Yavari N, Eslami G, Afsharfard A, Reza Kalantar-Motamedi SM, Zarrintan S. Comparing open conventional carpal tunnel release with mini-incision technique in the treatment of carpal tunnel syndrome: A non-randomized clinical trial. Ann Med Surg (Lond). 2020 May 16;55:119-123. doi: 10.1016/j.amsu.2020.05.001. eCollection 2020 Jul.

  PMID: 32477509 BACKGROUND

• 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.

  PMID: 24414237 BACKGROUND

• Michelotti BM, Vakharia KT, Romanowsky D, Hauck RM. A Prospective, Randomized Trial Comparing Open and Endoscopic Carpal Tunnel Release Within the Same Patient. Hand (N Y). 2020 May;15(3):322-326. doi: 10.1177/1558944718812129. Epub 2018 Nov 21.

  PMID: 30461319 BACKGROUND

• Shin EK. Endoscopic Versus Open Carpal Tunnel Release. Curr Rev Musculoskelet Med. 2019 Dec;12(4):509-514. doi: 10.1007/s12178-019-09584-0.

  PMID: 31773481 BACKGROUND

• Kang HJ, Koh IH, Lee TJ, Choi YR. Endoscopic carpal tunnel release is preferred over mini-open despite similar outcome: a randomized trial. Clin Orthop Relat Res. 2013 May;471(5):1548-54. doi: 10.1007/s11999-012-2666-z. Epub 2012 Oct 26.

  PMID: 23100191 BACKGROUND

• Hu K, Zhang T, Xu W. Intraindividual comparison between open and endoscopic release in bilateral carpal tunnel syndrome: a meta-analysis of randomized controlled trials. Brain Behav. 2016 Feb 16;6(3):e00439. doi: 10.1002/brb3.439. eCollection 2016 Mar.

  PMID: 27099801 BACKGROUND

• Zuo D, Zhou Z, Wang H, Liao Y, Zheng L, Hua Y, Cai Z. Endoscopic versus open carpal tunnel release for idiopathic carpal tunnel syndrome: a meta-analysis of randomized controlled trials. J Orthop Surg Res. 2015 Jan 28;10:12. doi: 10.1186/s13018-014-0148-6.

  PMID: 25627324 BACKGROUND

• 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.

  PMID: 34150584 BACKGROUND

• Teng X, Xu J, Yuan H, He X, Chen H. Comparison of Wrist Arthroscopy, Small Incision Surgery, and Conventional Surgery for the Treatment of Carpal Tunnel Syndrome: A Retrospective Study at a Single Center. Med Sci Monit. 2019 Jun 3;25:4122-4129. doi: 10.12659/MSM.912912.

  PMID: 31155608 BACKGROUND

• Xu L, Huang F, Hou C. Treatment for carpal tunnel syndrome by coronal Z-type lengthening of the transverse carpal ligament. J Pak Med Assoc. 2011 Nov;61(11):1068-71.

  PMID: 22125980 BACKGROUND

• Castro-Menendez M, Pagazaurtundua-Gomez S, Pena-Paz S, Huici-Izco R, Rodriguez-Casas N, Montero-Vieites A. Z-Elongation of the transverse carpal ligament vs. complete resection for the treatment of carpal tunnel syndrome. Rev Esp Cir Ortop Traumatol. 2016 Nov-Dec;60(6):355-365. doi: 10.1016/j.recot.2016.06.007. Epub 2016 Aug 25. English, Spanish.

  PMID: 27569033 BACKGROUND

• Dias JJ, Bhowal B, Wildin CJ, Thompson JR. Carpal tunnel decompression. Is lengthening of the flexor retinaculum better than simple division? J Hand Surg Br. 2004 Jun;29(3):271-6. doi: 10.1016/j.jhsb.2004.01.011.

  PMID: 15142699 BACKGROUND

• Karlsson MK, Lindau T, Hagberg L. Ligament lengthening compared with simple division of the transverse carpal ligament in the open treatment of carpal tunnel syndrome. Scand J Plast Reconstr Surg Hand Surg. 1997 Mar;31(1):65-9. doi: 10.3109/02844319709010507.

  PMID: 9075290 BACKGROUND

• Saravi MS, Kariminasab MH, Bari M, Ghaffari S, Razavipour M, Daneshpoor SM, Yazdi MV, Davoudi MM, Azar MS. A Comparison of Hand Pain and Hand Function after Z-plasty Reconstruction of the Transverse Carpal Ligament with Traditional Median Neurolysis in Carpal Tunnel Syndrome. Arch Bone Jt Surg. 2016 Apr;4(2):145-9.

  PMID: 27200393 BACKGROUND

• Netscher D, Steadman AK, Thornby J, Cohen V. Temporal changes in grip and pinch strength after open carpal tunnel release and the effect of ligament reconstruction. J Hand Surg Am. 1998 Jan;23(1):48-54. doi: 10.1016/S0363-5023(98)80088-9.

  PMID: 9523954 BACKGROUND

• Faour-Martín O, Martín-Ferrero MA, Valverde JA, Zuil-Acosta P, Amigo-Liñares L, Alarcón-García J, De la Red MA. The Simonetta Technique for Carpal Tunnel Syndrome: Immediate Postoperative Evaluation and Long-Term Comparative Study. Int Journal of Orthopaedics. 2014 1(3): 109-115

  BACKGROUND

• Zhang X, Li Y, Wen S, Zhu H, Shao X, Yu Y. Carpal tunnel release with subneural reconstruction of the transverse carpal ligament compared with isolated open and endoscopic release. Bone Joint J. 2015 Feb;97-B(2):221-8. doi: 10.1302/0301-620X.97B2.34423.

  PMID: 25628286 BACKGROUND

• Levine DW, Simmons BP, Koris MJ, Daltroy LH, Hohl GG, Fossel AH, Katz JN. A self-administered questionnaire for the assessment of severity of symptoms and functional status in carpal tunnel syndrome. J Bone Joint Surg Am. 1993 Nov;75(11):1585-92. doi: 10.2106/00004623-199311000-00002.

  PMID: 8245050 BACKGROUND

MeSH Terms

Conditions

Carpal Tunnel Syndrome

Interventions

Congresses as Topic

Condition Hierarchy (Ancestors)

Median Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Organizations; Health Care Economics and Organizations

Results Point of Contact

• Title: Ms. Irene Calzado Álvarez de Lara
• Organization: Hospital Universitario Reina Sofía

ircaalla@gmail.com

+34618093419

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: This is a double-blind study, in which both the patient and the evaluating staff are unaware of the surgical technique used (both surgeons will perform both techniques). A traumatologist will analyze (before and after surgery) the clinic, strength and satisfaction of the patients.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Patients will be randomly assigned to one of two treatment groups in a 1:1 ratio, using a computer-generated random assignment list

Study Record Dates

• First Submitted: July 14, 2022
• First Posted: July 21, 2022
• Study Start: July 18, 2022
• Primary Completion: April 28, 2023
• Study Completion: May 28, 2023
• Last Updated: September 19, 2024
• Results First Posted: September 19, 2024

Record last verified: 2024-05

Locations

ES (1)