Functional Recovery and Pain Reduction Post-hydrodissection vs Rehabilitation in Patients With Carpal Tunnel Syndrome (Hydrocarpal)

NCT ID: NCT06590129

Last Updated: 2025-01-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-01

Study Completion Date

2024-02-29

Brief Summary

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

Detailed Description

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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.

Conditions

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Carpal Tunnel Syndrome (CTS)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Only Rehabilitation

Evaluated with the Boston questionnaire and the Visual Analogue Scale (VAS), then te patients were enroled to a 15-20 sessions in rehabilitation area with physical media: paraffin glove (10 coats for 15min), mobilizations of wrist and fingers, strectching of wrist and fingers tendons/muscles, muscle stregthening whit isometric or isotonic excercises to intrinsic muscles of the hand an forearm, and occupational therapy with techniques for sensory return, nerve and tendon sliding techniques, activities aimed at improving basic hand functions and work simulation activities.

Group Type ACTIVE_COMPARATOR

Physiotherapy

Intervention Type OTHER

5-20 sessions in rehabilitation area with physical media: paraffin glove (10 coats for 15min), mobilizations of wrist and fingers, strectching of wrist and fingers tendons/muscles, muscle stregthening whit isometric or isotonic excercises to intrinsic muscles of the hand an forearm, and occupational therapy with techniques for sensory return, nerve and tendon sliding techniques, activities aimed at improving basic hand functions and work simulation activities.

Median nerve ultrasound guided hidrodissection + rehabilitation

Evaluated with the Boston questionnaire and the Visual Analogue Scale (VAS), then an ultrasound guided hidrodissection of the median nerve with 4.5ml of glucosade solution was performed.

The patients were enrolled into 15-20 sessions in rehabilitation área with the same protocolo of the control group.

Group Type EXPERIMENTAL

hydrodissection of median nerve

Intervention Type PROCEDURE

Ultrasound guided hydrodissection of median nerve in carpal tunnel with 5% dextrose solution

Physiotherapy

Intervention Type OTHER

5-20 sessions in rehabilitation area with physical media: paraffin glove (10 coats for 15min), mobilizations of wrist and fingers, strectching of wrist and fingers tendons/muscles, muscle stregthening whit isometric or isotonic excercises to intrinsic muscles of the hand an forearm, and occupational therapy with techniques for sensory return, nerve and tendon sliding techniques, activities aimed at improving basic hand functions and work simulation activities.

Interventions

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hydrodissection of median nerve

Ultrasound guided hydrodissection of median nerve in carpal tunnel with 5% dextrose solution

Intervention Type PROCEDURE

Physiotherapy

5-20 sessions in rehabilitation area with physical media: paraffin glove (10 coats for 15min), mobilizations of wrist and fingers, strectching of wrist and fingers tendons/muscles, muscle stregthening whit isometric or isotonic excercises to intrinsic muscles of the hand an forearm, and occupational therapy with techniques for sensory return, nerve and tendon sliding techniques, activities aimed at improving basic hand functions and work simulation activities.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Instituto Mexicano del Seguro Social

OTHER_GOV

Sponsor Role lead

Responsible Party

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Roberto Carlos Pech Arguelles

Director of Research

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Hospital General Regional No.1 "Lic. Ignacio García Téllez" IMSS, Calle 41 101, Fénix, 97155 Mérida, Yuc.

Mérida, Yucatán, Mexico

Site Status

Countries

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Mexico

References

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Lin CP, Chang KV, Huang YK, Wu WT, Ozcakar L. Regenerative Injections Including 5% Dextrose and Platelet-Rich Plasma for the Treatment of Carpal Tunnel Syndrome: A Systematic Review and Network Meta-Analysis. Pharmaceuticals (Basel). 2020 Mar 18;13(3):49. doi: 10.3390/ph13030049.

Reference Type BACKGROUND
PMID: 32197544 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31368191 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28778254 (View on PubMed)

Neo EJR, Shan NT, Tay SS. Hydrodissection for Carpal Tunnel Syndrome: A Systematic Review. Am J Phys Med Rehabil. 2022 Jun 1;101(6):530-539. doi: 10.1097/PHM.0000000000001846. Epub 2021 Jul 14.

Reference Type BACKGROUND
PMID: 34261895 (View on PubMed)

Wu YT, Chen YP, Lam KHS, Reeves KD, Lin JA, Kuo CY. Mechanism of Glucose Water as a Neural Injection: A Perspective on Neuroinflammation. Life (Basel). 2022 Jun 2;12(6):832. doi: 10.3390/life12060832.

Reference Type BACKGROUND
PMID: 35743863 (View on PubMed)

Kjeken I, Sundin U. Management of carpal tunnel syndrome in primary care. Rheumatology (Oxford). 2023 Feb 1;62(2):495-496. doi: 10.1093/rheumatology/keac396. No abstract available.

Reference Type BACKGROUND
PMID: 35894646 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26440776 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32313774 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25175160 (View on PubMed)

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.

Reference Type BACKGROUND

Related Links

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https://www.uptodate.com/contents/carpal-tunnel-syndrome-treatment-and-prognosis

Carpal tunnel syndrome: Treatment and prognosis \[Internet\]. UpToDate

https://www.uptodate.com/contents/surgery-for-carpal-tunnel-syndrome

Surgery for carpal tunnel syndrome \[Internet\]. UpToDate.

Other Identifiers

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R-2023-3201-068

Identifier Type: -

Identifier Source: org_study_id

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