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NCT Number: NCT06942273

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

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.

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Key information

Conditions

Carpal Tunnel Syndrome (CTS) Body Temperature Changes Carpal Tunnel Syndrome Cumulative Trauma Disorders Frequency of Therapy Heat Stress Disorders Hyperthermia Median Neuropathy Mononeuropathies Nerve Compression Syndromes Nervous System Diseases Neuromuscular Diseases Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Signs and Symptoms Sprains and Strains Wounds and Injuries

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

hyperthermia

Radiation

hyperthermia over the carpal tunnel area and adjacent areas

Physical exercise

Other

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

splint

Other

imposition of a night splint

Primary outcomes

  1. Boston Carpal Tunnel Syndrome Questionnaire (BCTQ)

    Time frame: Baseline and up to one year

    Minimum: 19. Maximum: 95. A higher score indicates a higher degree of disability

  2. Disabilities of arm, shoulder and hand (DASH)

    Time frame: Baseline and up to one year

    Minimum: 30 points. Maximum: 150 points A higher score indicates a higher intensity of symptoms

  3. Neuropathic Pain Scale (DN4)

    Time frame: Baseline and up to one year

    Minimum: 0 Maximum: 10 The diagnosis of neuropathic pain is established with a total scale of 4 out of 10

  4. International Physical Activity Questionnaire (IPAQ)

    Time frame: Baseline and up to one year

    9 items. Minimum: 9 Maximum: 36 A higher score indicates a sedentary life

  5. Visual Analogue Scale (VAS)

    Time frame: Baseline and up to one year

    Minimum: 1 Maximum: 10 A higher score indicates a higher intensity of pain

  6. Hand grip strength

    Time frame: Baseline and up to one year

    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.

  7. WRIST JOINT RANGE OF MOBILITY

    Time frame: Baseline and up to one year

    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.

  8. WRIST FLEXION EVALUATION TEST

    Time frame: Baseline and up to one year

    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.

Sponsors and collaborators

Lead sponsor

University of Malaga

Other

Registry information

Official study 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.

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Apr 24, 2025
Registry last updated
Apr 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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