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Not yet recruiting NCT06942273

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

No phase Interventional Carpal Tunnel Syndrome (CTS) Hyperthermia Frequency of Therapy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: hyperthermia, physical exercise, splint.
Who it may be relevant to
Registry conditions: Carpal Tunnel Syndrome (CTS), Hyperthermia, Frequency of Therapy. Basic parameters: 18 years — 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Radiation hyperthermia
    hyperthermia over the carpal tunnel area and adjacent areas
  • Other physical exercise
    Performing therapeutic physical exercise focused on the flexor muscles of the hand and neural stretching
  • Other splint
    imposition of a night splint

Primary outcome measures

  • Boston Carpal Tunnel Syndrome Questionnaire (BCTQ) [Time frame: Baseline and up to one year]
  • Disabilities of arm, shoulder and hand (DASH) [Time frame: Baseline and up to one year]
  • Neuropathic Pain Scale (DN4) [Time frame: Baseline and up to one year]
  • International Physical Activity Questionnaire (IPAQ) [Time frame: Baseline and up to one year]
  • Visual Analogue Scale (VAS) [Time frame: Baseline and up to one year]
  • Hand grip strength [Time frame: Baseline and up to one year]
  • WRIST JOINT RANGE OF MOBILITY [Time frame: Baseline and up to one year]
  • WRIST FLEXION EVALUATION TEST [Time frame: Baseline and up to one year]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06942273 · 45/2025

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗