Clinical trial NCT06590129: Functional Recovery and Pain Reduction Post-hydrodissection vs Rehabilitation in Patients With Carpal Tunnel Syndrome (Hydrocarpal)
Official title: Effectiveness in Functional Recovery and Pain Reduction Following Hydrodissection vs Rehabilitation in Patients With Carpal Tunnel Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Carpal Tunnel Syndrome (CTS)
Keywords: Carpal Tunnel Syndrome
Rehabilitation
physical therapy
Hidrodissection
Physiotherapy
Median nerve neuropathy
Lead sponsor: Instituto Mexicano del Seguro Social
Sponsor class: OTHER_GOV
First posted: 2024-09-19
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective, longitudinal, randomized clinical study, including 50 patients diagnosed with CTS. Two groups were compared: one received physical therapy and the other received median nerve ultrasound guided hydrodissection plus physiotherapy evaluated initially, 4 and 12 weeks with the Boston questionnaire and the Visual Analogue Scale (VAS).
Primary purpose: TREATMENT

Brief summary: This study pretend to evaluate the effectiveness of hydrodissection vs only rehabilitation in improving pain and function in patients with CTS.

Detailed description: This prospective, longitudinal, randomized in two groups clinical study pretend to evaluate the effectiveness of hydrodissection vs only rehabilitation in improving pain and function in patients with CTS, evaluated initially and at 4 and 12 weeks.

Eligibility criteria: Inclusion Criteria:

* men and women ≥18 years of age,
* members referred to and treated at the Physical Medicine and Rehabilitation Service of HGR N°1, IMSS Mérida Yucatán, and who had a clinical or electrophysiological diagnosis of carpal tunnel syndrome.

Exclusion Criteria:

* included a clinical or electrophysiological diagnosis of radiculopathy, plexopathy, polyneuropathy, or other peripheral neuropathy;
* current diagnosis of cancer, coagulopathy, thoracic outlet syndrome;
* active infectious process or current fracture in the thoracic limb;
* previous surgery for carpal tunnel release;
* inability to cooperate with filling out scales, physical examination, or infiltration, as clearly detailed.

Primary outcomes:
measure: Function
timeFrame: Initially, 4 and 12 weeks.
measure: Pain
timeFrame: Initially, 4 and 12 weeks.
Secondary outcomes:
Other outcomes:
Locations:
city: Merida
country: Mexico
facility: Hospital General Regional No.1 &#34;Lic. Ignacio García Téllez&#34; IMSS, Calle 41 101, Fénix, 97155 Mérida, Yuc.
state: Yucatán
Study officials:
References:
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citation: Shen YP, Li TY, Chou YC, Ho TY, Ke MJ, Chen LC, Wu YT. Comparison of perineural platelet-rich plasma and dextrose injections for moderate carpal tunnel syndrome: A prospective randomized, single-blind, head-to-head comparative trial. J Tissue Eng Regen Med. 2019 Nov;13(11):2009-2017. doi: 10.1002/term.2950. Epub 2019 Aug 20.
citation: Wu YT, Ho TY, Chou YC, Ke MJ, Li TY, Tsai CK, Chen LC. Six-month Efficacy of Perineural Dextrose for Carpal Tunnel Syndrome: A Prospective, Randomized, Double-Blind, Controlled Trial. Mayo Clin Proc. 2017 Aug;92(8):1179-1189. doi: 10.1016/j.mayocp.2017.05.025.
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citation: Burton CL, Chesterton LS, Chen Y, van der Windt DA. Clinical Course and Prognostic Factors in Conservatively Managed Carpal Tunnel Syndrome: A Systematic Review. Arch Phys Med Rehabil. 2016 May;97(5):836-852.e1. doi: 10.1016/j.apmr.2015.09.013. Epub 2015 Oct 9.
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citation: Thiese MS, Gerr F, Hegmann KT, Harris-Adamson C, Dale AM, Evanoff B, Eisen EA, Kapellusch J, Garg A, Burt S, Bao S, Silverstein B, Merlino L, Rempel D. Effects of varying case definition on carpal tunnel syndrome prevalence estimates in a pooled cohort. Arch Phys Med Rehabil. 2014 Dec;95(12):2320-6. doi: 10.1016/j.apmr.2014.08.004. Epub 2014 Aug 28.
citation: Lores Peniche JA, Huchim Lara O, Méndez-Domínguez N. Carpal Tunnel Syndrome: Epidemiological Analysis of Cases Treated in Hospital Services in Mexico. Physiotherapy. 2020;42(2):69-74.