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.

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Hyperthermia; Carpal Tunnel Syndrome (CTS); Frequency of Therapy
• Intervention / Treatment: Radiation: hyperthermia; Other: physical exercise; Other: splint

• Study Type: Interventional
• Enrollment (Estimated): 160
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Hyperthermia 2 times per week	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
Experimental: Hyperthermia 3 times per week	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
Experimental: Non-hyperthermia 2 times per week	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
Experimental: Non-hyperthermia 3 times per week	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Boston Carpal Tunnel Syndrome Questionnaire (BCTQ)	Minimum: 19. Maximum: 95. A higher score indicates a higher degree of disability	Baseline and up to one year
Disabilities of arm, shoulder and hand (DASH)	Minimum: 30 points. Maximum: 150 points A higher score indicates a higher intensity of symptoms	Baseline and up to one year
Neuropathic Pain Scale (DN4)	Minimum: 0 Maximum: 10 The diagnosis of neuropathic pain is established with a total scale of 4 out of 10	Baseline and up to one year
International Physical Activity Questionnaire (IPAQ)	9 items. Minimum: 9 Maximum: 36 A higher score indicates a sedentary life	Baseline and up to one year
Visual Analogue Scale (VAS)	Minimum: 1 Maximum: 10 A higher score indicates a higher intensity of pain	Baseline and up to one year
Hand grip strength	A handheld dynamometer will be used and three consecutive measurements will be obtained with the patient sitting and the elbow flexed at 90 degrees and in a neutral position.	Baseline and up to one year
WRIST JOINT RANGE OF MOBILITY	With the patient seated in a relaxed position, the various free movements of the wrist joint will be assessed bilaterally using an electronic goniometer. To do this, the goniometer will be placed on the dorsal side of the wrist, with the proximal part on the midline between the radius and ulna and the distal part on the third metacarpal. Flexion, extension, and radial and ulnar deviation ranges will be assessed, both with the elbow flexed and extended.	Baseline and up to one year
WRIST FLEXION EVALUATION TEST	With the patient seated in a relaxed position, wrist flexion will be tested in isometric contraction, both with the hand open and closed, and with the wrist in a neutral position. The therapist will manually resist wrist flexion from the hand area. This test will be performed three times in a row with the hand open, followed by a five-minute rest and then repeating the procedure, this time with the hand open. This measurement will be taken with the elbow flexed or extended.	Baseline and up to one year

Collaborators and Investigators

• Sponsor: University of Malaga

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2025
• Primary Completion (Estimated): October 31, 2025
• Study Completion (Estimated): April 30, 2026

Study Registration Dates

• First Submitted: April 8, 2025
• First Submitted That Met QC Criteria: April 16, 2025
• First Posted (Actual): April 24, 2025

Study Record Updates

• Last Update Posted (Actual): April 24, 2025
• Last Update Submitted That Met QC Criteria: April 16, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Wounds and Injuries; Pathologic Processes; Neuromuscular Diseases; Peripheral Nervous System Diseases; Disease; Body Temperature Changes; Median Neuropathy; Mononeuropathies; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Heat Stress Disorders; Hyperthermia; Syndrome; Carpal Tunnel Syndrome; Fever
• Other Study ID Numbers: 45/2025

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No