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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorUniversity of Malaga

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Have a diagnosis confirmed by performing an electromyography of Carpal Tunnel Syndrome

Have not yet received physiotherapy treatment.

Disqualifiers

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

Design model

Parallel

Treatments tested in this trial

  • hyperthermia

    Radiation

    hyperthermia over the carpal tunnel area and adjacent areas

  • physical exercise

    Other intervention

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

  • splint

    Other intervention

    imposition of a night splint

Treatment groups

160 Participants
are divided into 4 treatment groups
Group A: Hyperthermia 2 times per weekExperimental treatment 3 interventions
Group B: Hyperthermia 3 times per weekExperimental treatment 3 interventions
Group C: Non-hyperthermia 2 times per weekExperimental treatment 2 interventions
Group D: Non-hyperthermia 3 times per weekExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Boston Carpal Tunnel Syndrome Questionnaire (BCTQ)

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

Time frame
Baseline and up to one year
2

Disabilities of arm, shoulder and hand (DASH)

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

Time frame
Baseline and up to one year
3

Neuropathic Pain Scale (DN4)

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

Time frame
Baseline and up to one year
4

International Physical Activity Questionnaire (IPAQ)

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

Time frame
Baseline and up to one year

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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