Clinical trial NCT06942273: Analysis of Hyperthermia as a Complementary Treatment to Evidence-based Clinical Intervention in Subjects With Carpal Tunnel Syndrome:
Official 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.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Carpal Tunnel Syndrome (CTS)
Hyperthermia
Frequency of Therapy
Lead sponsor: University of Malaga
Sponsor class: OTHER
First posted: 2025-04-24
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Boston Carpal Tunnel Syndrome Questionnaire (BCTQ)
timeFrame: Baseline and up to one year
measure: Disabilities of arm, shoulder and hand (DASH)
timeFrame: Baseline and up to one year
measure: Neuropathic Pain Scale (DN4)
timeFrame: Baseline and up to one year
measure: International Physical Activity Questionnaire (IPAQ)
timeFrame: Baseline and up to one year
measure: Visual Analogue Scale (VAS)
timeFrame: Baseline and up to one year
measure: Hand grip strength
timeFrame: Baseline and up to one year
measure: WRIST JOINT RANGE OF MOBILITY
timeFrame: Baseline and up to one year
measure: WRIST FLEXION EVALUATION TEST
timeFrame: Baseline and up to one year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
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