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NCT Number: NCT06590129

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

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

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Key information

Conditions

Carpal Tunnel Syndrome (CTS) Carpal Tunnel Syndrome Cumulative Trauma Disorders Median Neuropathy Mononeuropathies Nerve Compression Syndromes Nervous System Diseases Neuromuscular Diseases Peripheral Nervous System Diseases Sprains and Strains Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Mérida, Yucatán, 97155, Mexico

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

hydrodissection of median nerve

Procedure

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

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.

Primary outcomes

  1. Function

    Time frame: Initially, 4 and 12 weeks.

    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.

  2. Pain

    Time frame: Initially, 4 and 12 weeks.

    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.

Sponsors and collaborators

Lead sponsor

Instituto Mexicano del Seguro Social

Other Gov

Registry information

Official study title

Effectiveness in Functional Recovery and Pain Reduction Following Hydrodissection vs Rehabilitation in Patients With Carpal Tunnel Syndrome

Acronym: hydrocarpal

Important dates

Study start
2023
Primary completion
2023
Study completion
2024
First posted
Sep 19, 2024
Registry last updated
Jan 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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