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

NCT06942273 | Not Yet Recruiting

• 1 other identifier: 45/2025
• Study Type: interventional
• Target: 160
• Locations: 0 countries
• Sites: N/A

Brief 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

Outcome Measures

Primary Outcomes (8)

• 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

Study Arms (4)

Hyperthermia 2 times per week

EXPERIMENTAL

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

Hyperthermia 3 times per week

EXPERIMENTAL

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

Non-hyperthermia 2 times per week

EXPERIMENTAL

Other: physical exercise; Other: splint

Non-hyperthermia 3 times per week

EXPERIMENTAL

Other: physical exercise; Other: splint

Interventions

hyperthermia RADIATION

hyperthermia over the carpal tunnel area and adjacent areas

Hyperthermia 2 times per week; Hyperthermia 3 times per week

physical exercise OTHER

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

Hyperthermia 2 times per week; Hyperthermia 3 times per week; Non-hyperthermia 2 times per week; Non-hyperthermia 3 times per week

splint OTHER

imposition of a night splint

Hyperthermia 2 times per week; Hyperthermia 3 times per week; Non-hyperthermia 2 times per week; Non-hyperthermia 3 times per week

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Malaga: lead

MeSH Terms

Conditions

Carpal Tunnel Syndrome; Hyperthermia

Interventions

Diathermy; Exercise; Splints

Condition Hierarchy (Ancestors)

Median Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Wounds and Injuries; Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Heat Stress Disorders

Intervention Hierarchy (Ancestors)

Hyperthermia, Induced; Therapeutics; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; External Fixators; Orthopedic Fixation Devices; Orthopedic Equipment; Surgical Equipment; Equipment and Supplies; Surgical Fixation Devices

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 8, 2025
• First Posted: April 24, 2025
• Study Start: May 1, 2025
• Primary Completion: October 31, 2025
• Study Completion: April 30, 2026
• Last Updated: April 24, 2025

Record last verified: 2025-04