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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.
It will be a randomized clinical trial with a sample size of about 80 patients. It will have two study groups: the experimental group (in which 40 patients will be included) where a Z-plasty technique will be applied; and the control group (another 40 patients) who will undergo the conventional technique of complete section of the transverse carpal ligament. The main variable will be the presence or absence of post-surgical pillar pain and, as secondary variables, the recovery of grip and pincer strength and the improvement in the BCTQ score will be studied.
The study population will be patients with carpal tunnel syndrome diagnosed clinically (pain and paresthesias in the first three fingers and radial edge of the fourth finger, nocturnal paresthesias, thenar muscle atrophy, loss of thumb opposition), examination (Durkan's signs , Phalen and Tinnel positive) and with a positive electromyogram test classified as "moderate" or "severe". As inclusion criteria, patients >18 years of age with moderate-severe carpal tunnel syndrome whose symptoms hinder the daily activities of the patient and who have failed conservative treatment will be considered. Those who have already undergone a previous surgical intervention for carpal tunnel syndrome in the same hand, who have traumatic or congenital sequelae in the hand or who do not have the capacity to understand the process or the tests to be performed will be excluded.
The total expected duration of each patient in the study will be 6 months and the following visits and procedures will be carried out: clinical study and quality questionnaires prior to surgery and post-surgical follow-up at 3-4 weeks and at 6 months in consultation, with repetition of clinical examination and quality questionnaires.
The incidence of pillar pain (defined as pain/sensation of allodynia in the area of the thenar and/or hypothenar eminence, hyperalgesia in the scar, pain when supporting the heel of the hand, dysesthesia at rest) will be analyzed applying the principle of intention to treat, using the Mann Whitney test to compare the score in the tests used.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Conventional | Active Comparator | It is a surgical technique in which a complete section of the transverse carpal ligament is performed, without subsequent closure. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Grip Strength | Grip strength measured with a dynamometer | 3 weeks after surgery |
| Grip Strength | Grip strength measured with a dynamometer |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario Reina Sofia | Córdoba | 14004 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32313774 | Background | 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. | |
| 9399176 | 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. |
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Not specified. The assignment was randomized
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| ID | Title | Description |
|---|---|---|
| FG000 | Z-plasty | 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: 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. |
| FG001 | Conventional | It is a surgical technique in which a complete section of the transverse carpal ligament is performed, without subsequent closure. Conventional: It is a surgical technique in which a complete section of the transverse carpal ligament is performed, without subsequent closure. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Z-plasty | 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. |
| BG001 | Conventional |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Posted | Count of Participants | Participants | 3 weeks after surgery |
|
6 months
Major surgical complications: infection, wound dehiscence, amputation...
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Z-plasty | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ms. Irene Calzado Álvarez de Lara | Hospital Universitario Reina Sofía | +34618093419 | ircaalla@gmail.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 27, 2022 | May 6, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D002349 | Carpal Tunnel Syndrome |
| ID | Term |
|---|---|
| D020423 | Median Neuropathy |
| D020422 | Mononeuropathies |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
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| ID | Term |
|---|---|
| D003226 | Congresses as Topic |
| ID | Term |
|---|---|
| D009938 | Organizations |
| D004472 | Health Care Economics and Organizations |
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Patients will be randomly assigned to one of two treatment groups in a 1:1 ratio, using a computer-generated random assignment list
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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.
| Conventional | Procedure | It is a surgical technique in which a complete section of the transverse carpal ligament is performed, without subsequent closure. |
|
| 6 months |
| Pinch Strength | Pinch strength measured with a dynamometer | 3 weeks |
| Pinch Strength | Pinch strength measured with a dynamometer | 6 months |
| Clinical BCTQ | Boston Carpal Tunnel Syndrome Questionnaire used to evaluate the clinic of carpal tunnel syndrome. Minimum: 1 (better). Maximum: 5 (worse) | 3 weeks after surgery |
| Functional BCTQ | Boston Carpal Tunnel Syndrome Questionnaire used to evaluate the clinic of carpal tunnel syndrome. Minimum: 1 (better). Maximum: 5 (worse) | 6 months |
| Clinical BCTQ | Boston Carpal Tunnel Syndrome Questionnaire used to evaluate the clinic (symptoms) of carpal tunnel syndrome. Minimum: 1 (better). Maximum: 5 (worse) | 6 months |
| Functional BCTQ | Boston Carpal Tunnel Syndrome Questionnaire used to evaluate the clinic (functionality; daily activities) of carpal tunnel syndrome. Minimum: 1 (better). Maximum: 5 (worse) | 3 weeks after surgery |
| 25767419 | 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. |
| 29471152 | 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. |
| 32477509 | 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. |
| 24414237 | 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. |
| 30461319 | 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. |
| 31773481 | 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. |
| 23100191 | 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. |
| 27099801 | 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. |
| 25627324 | 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. |
| 34150584 | 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. |
| 31155608 | 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. |
| 22125980 | 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. |
| 27569033 | 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. |
| 15142699 | 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. |
| 9075290 | 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. |
| 27200393 | 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. |
| 9523954 | 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. |
| 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 |
| 25628286 | 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. |
| 8245050 | 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. |
It is a surgical technique in which a complete section of the transverse carpal ligament is performed, without subsequent closure.
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Laterality | Number | Number of participants right handed |
|
| Atrophy | Count of Participants | Participants |
|
| Baseline grip strength | Mean | Standard Deviation | kilograms |
|
| Baseline pinch strength | Mean | Standard Deviation | kilograms |
|
| Baseline clinical BCTQ | Boston Carpal Tunnel Questionnaire. Scale from best to worst (1 - 5) | Mean | Standard Deviation | units on a scale |
|
| Baseline functional BCTQ | Boston Carpal Tunnel Questionnaire. Scale from best to worst (1 - 5) | Mean | Standard Deviation | units on a scale |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Primary | 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 | Posted | Count of Participants | Participants | 6 months after surgery |
|
|
|
| Secondary | Grip Strength | Grip strength measured with a dynamometer | Posted | Mean | Standard Deviation | kilograms | 3 weeks after surgery |
|
|
|
| Secondary | Grip Strength | Grip strength measured with a dynamometer | Posted | Mean | Standard Deviation | kilograms | 6 months |
|
|
|
| Secondary | Pinch Strength | Pinch strength measured with a dynamometer | Posted | Mean | Standard Deviation | kilograms | 3 weeks |
|
|
|
| Secondary | Pinch Strength | Pinch strength measured with a dynamometer | Posted | Mean | Standard Deviation | kilograms | 6 months |
|
|
|
| Secondary | Clinical BCTQ | Boston Carpal Tunnel Syndrome Questionnaire used to evaluate the clinic of carpal tunnel syndrome. Minimum: 1 (better). Maximum: 5 (worse) | Posted | Mean | Standard Deviation | units on a scale | 3 weeks after surgery |
|
|
|
| Secondary | Functional BCTQ | Boston Carpal Tunnel Syndrome Questionnaire used to evaluate the clinic of carpal tunnel syndrome. Minimum: 1 (better). Maximum: 5 (worse) | Posted | Mean | Standard Deviation | units on a scale | 6 months |
|
|
|
| Secondary | Clinical BCTQ | Boston Carpal Tunnel Syndrome Questionnaire used to evaluate the clinic (symptoms) of carpal tunnel syndrome. Minimum: 1 (better). Maximum: 5 (worse) | Posted | Mean | Standard Deviation | units on a scale | 6 months |
|
|
|
| Secondary | Functional BCTQ | Boston Carpal Tunnel Syndrome Questionnaire used to evaluate the clinic (functionality; daily activities) of carpal tunnel syndrome. Minimum: 1 (better). Maximum: 5 (worse) | Posted | Mean | Standard Deviation | units on a scale | 3 weeks after surgery |
|
|
|
| 0 |
| 55 |
| 0 |
| 55 |
| 0 |
| 55 |
| EG001 | Conventional | It is a surgical technique in which a complete section of the transverse carpal ligament is performed, without subsequent closure. | 0 | 54 | 0 | 54 | 0 | 54 |
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| D009422 | Nervous System Diseases |
| D009408 | Nerve Compression Syndromes |
| D012090 | Cumulative Trauma Disorders |
| D013180 | Sprains and Strains |
| D014947 | Wounds and Injuries |