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

University of Malaga

Status: Not yet enrolling

Conditions: Hyperthermia; Frequency of Therapy; Carpal Tunnel Syndrome (CTS)

Treatments: Other: physical exercise; Radiation: hyperthermia; Other: splint

Study type: Interventional

Funder types: Other

Identifiers

NCT06942273

45/2025

Details and patient eligibility

About

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.

Enrollment: 160 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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160 participants in 4 patient groups

Hyperthermia 2 times per week

Experimental group

Treatment:

Other: splint

Radiation: hyperthermia

Other: physical exercise

Hyperthermia 3 times per week

Experimental group

Treatment:

Other: splint

Radiation: hyperthermia

Other: physical exercise

Non-hyperthermia 2 times per week

Experimental group

Treatment:

Other: splint

Other: physical exercise

Non-hyperthermia 3 times per week

Experimental group

Treatment:

Other: splint

Other: physical exercise