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

NCT06590129 | Completed

• 1 other identifier: R-2023-3201-068
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Carpal Tunnel Syndrome (CTS)

Keywords

Carpal Tunnel Syndrome; Rehabilitation; physical therapy; Hidrodissection; Physiotherapy; Median nerve neuropathy

Outcome Measures

Primary Outcomes (2)

• Function

  Boston´s carpal tunnel questionnaire results, where each item is scored from 1 (no symptoms/difficulties) to 5 (the worst symptoms/cannot perform the activity at all). The mean score for each scale is calculated, resulting in a score between 1 and 5, with higher scores indicating worse symptoms or function.

  Initially, 4 and 12 weeks.

• Pain

  Visual Analogue Scale (VAS) is a pain intensity measurement tool that uses a 10 cm line with two end points to indicate no pain and worst possible pain.

  Initially, 4 and 12 weeks.

Study Arms (2)

Only Rehabilitation

ACTIVE COMPARATOR

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.

Other: Physiotherapy

Median nerve ultrasound guided hidrodissection + rehabilitation

EXPERIMENTAL

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.

Procedure: hydrodissection of median nerve; Other: Physiotherapy

Interventions

hydrodissection of median nerve PROCEDURE

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

Median nerve ultrasound guided hidrodissection + rehabilitation

Physiotherapy 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; Only Rehabilitation

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Instituto Mexicano del Seguro Social: lead

Study Sites (1)

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

Mérida, Yucatán, 97155, Mexico

Location

Related Publications (10)

• 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.

  PMID: 32197544 BACKGROUND

• 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.

  PMID: 31368191 BACKGROUND

• 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.

  PMID: 28778254 BACKGROUND

• 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.

  PMID: 34261895 BACKGROUND

• 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.

  PMID: 35743863 BACKGROUND

• 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.

  PMID: 35894646 BACKGROUND

• 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.

  PMID: 26440776 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.

  PMID: 32313774 BACKGROUND

• 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.

  PMID: 25175160 BACKGROUND

• 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.

  BACKGROUND

Related Links

• Carpal tunnel syndrome: Treatment and prognosis \[Internet\]. UpToDate
• Surgery for carpal tunnel syndrome \[Internet\]. UpToDate.

MeSH Terms

Conditions

Carpal Tunnel Syndrome; Median Neuropathy

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

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)

Therapeutics; Rehabilitation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Research

Model Details: 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).

Study Record Dates

• First Submitted: September 6, 2024
• First Posted: September 19, 2024
• Study Start: August 1, 2023
• Primary Completion: November 30, 2023
• Study Completion: February 29, 2024
• Last Updated: January 7, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)