Analysis of Hyperthermia as a Complementary Treatment to Evidence-based Clinical Intervention in Subjects With Carpal Tunnel Syndrome:

NCT ID: NCT06942273

Last Updated: 2025-04-24

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

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-01

Study Completion Date

2026-04-30

Brief Summary

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This project aims to analyze the use of hyperthermia within a treatment protocol for Carpal Tunnel Syndrome (CTS), as well as to determine the difference between two and three sessions per week. Study participants will be divided into four intervention groups: the first will receive two sessions per week for a period of six months, while the second will receive three sessions per week for the same period. The treatment protocol will consist of therapeutic physical exercise focused on the hand flexor muscles and neural stretching, the application of hyperthermia to the carpal tunnel and adjacent areas, and the use of a night splint. The third and fourth intervention groups will receive the same treatment as mentioned above, but without hyperthermia. The third group will receive three sessions per week, while the second group will receive two sessions per week. Two different types of measurement variables will be used: objective variables will be used to measure hand flexor muscle strength and wrist free range of motion. Subjective variables will also be used through validated questionnaires covering physical activity, perceived functional limitations, upper limb functional assessment, neuropathic pain, and a visual analogue scale for pain perception.

Detailed Description

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Conditions

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Carpal Tunnel Syndrome (CTS) Hyperthermia Frequency of Therapy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Hyperthermia 2 times per week

Group Type EXPERIMENTAL

hyperthermia

Intervention Type RADIATION

hyperthermia over the carpal tunnel area and adjacent areas

physical exercise

Intervention Type OTHER

Performing therapeutic physical exercise focused on the flexor muscles of the hand and neural stretching

splint

Intervention Type OTHER

imposition of a night splint

Hyperthermia 3 times per week

Group Type EXPERIMENTAL

hyperthermia

Intervention Type RADIATION

hyperthermia over the carpal tunnel area and adjacent areas

physical exercise

Intervention Type OTHER

Performing therapeutic physical exercise focused on the flexor muscles of the hand and neural stretching

splint

Intervention Type OTHER

imposition of a night splint

Non-hyperthermia 2 times per week

Group Type EXPERIMENTAL

physical exercise

Intervention Type OTHER

Performing therapeutic physical exercise focused on the flexor muscles of the hand and neural stretching

splint

Intervention Type OTHER

imposition of a night splint

Non-hyperthermia 3 times per week

Group Type EXPERIMENTAL

physical exercise

Intervention Type OTHER

Performing therapeutic physical exercise focused on the flexor muscles of the hand and neural stretching

splint

Intervention Type OTHER

imposition of a night splint

Interventions

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hyperthermia

hyperthermia over the carpal tunnel area and adjacent areas

Intervention Type RADIATION

physical exercise

Performing therapeutic physical exercise focused on the flexor muscles of the hand and neural stretching

Intervention Type OTHER

splint

imposition of a night splint

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Have a diagnosis confirmed by performing an electromyography of Carpal Tunnel Syndrome
* Have not yet received physiotherapy treatment.

Exclusion Criteria

* Have undergone surgery.
* Those who refuse to participate in this study.
* Patients with muscle atrophy due to CTS.
* Medical conditions that are contraindications for hyperthermia therapy.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Malaga

OTHER

Sponsor Role lead

Responsible Party

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Dr. Manuel González-Sánchez

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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45/2025

Identifier Type: -

Identifier Source: org_study_id

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