NCT06942273

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

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 160 (estimated)
• Sponsor: University of Malaga · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Carpal Tunnel Syndrome (CTS)
• Hyperthermia
• Frequency of Therapy

Interventions

Type	Name	Description
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

Timeline

• Start date: 2025-05-01
• Primary completion: 2025-10-31
• Completion: 2026-04-30
• First posted: 2025-04-24
• Last updated: 2025-04-24