Carpal Tunnel Syndrome (CTS)NCT06942273
Analysis of Hyperthermia as a Complementary Treatment to Evidence-based Clinical Intervention in Subjects With Carpal Tunnel Syndrome:
A study testing hyperthermia, physical exercise and splint in people with Carpal Tunnel Syndrome (CTS) and Hyperthermia, run by University of Malaga.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Carpal Tunnel Syndrome (CTS), Hyperthermia, Frequency of Therapy
- What is being tested?
- hyperthermia, physical exercise and splint
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2025to 30 Apr 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Have a diagnosis confirmed by performing an electromyography of Carpal Tunnel Syndrome
- Have not yet received physiotherapy treatment.
Who cannot join
- 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.
About this study
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.
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.
- Being tested
- hyperthermia, physical exercise, splint
- Medical subject headings
- Carpal Tunnel Syndrome, Hyperthermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hyperthermiaRadiation
hyperthermia over the carpal tunnel area and adjacent areas
physical exerciseOther
Performing therapeutic physical exercise focused on the flexor muscles of the hand and neural stretching
splintOther
imposition of a night splint
| Study group | Role | What they receive |
|---|---|---|
| Hyperthermia 2 times per week | Experimental | Not described Receives: Radiation: hyperthermia; Other: physical exercise; Other: splint |
| Hyperthermia 3 times per week | Experimental | Not described Receives: Radiation: hyperthermia; Other: physical exercise; Other: splint |
| Non-hyperthermia 2 times per week | Experimental | Not described Receives: Other: physical exercise; Other: splint |
| Non-hyperthermia 3 times per week | Experimental | Not described Receives: Other: physical exercise; Other: splint |
What is being measured
The primary outcome is the main question the study is designed to answer.
Boston Carpal Tunnel Syndrome Questionnaire (BCTQ)
Minimum: 19. Maximum: 95. A higher score indicates a higher degree of disability
Measured: 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
Measured: 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
Measured: Baseline and up to one year
International Physical Activity Questionnaire (IPAQ)
9 items. Minimum: 9 Maximum: 36 A higher score indicates a sedentary life
Measured: Baseline and up to one year
Visual Analogue Scale (VAS)
Minimum: 1 Maximum: 10 A higher score indicates a higher intensity of pain
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline and up to one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2025
- Study start1 May 2025 (estimated)
- Primary completion31 Oct 2025 (estimated)
- Study completion30 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carpal Tunnel Syndrome (CTS)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Malaga
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Manuel González-Sánchez, University of Malaga
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06942273
- Sponsor's protocol ID
- 45/2025
- Status last verified
- Apr 2025
- First submitted
- 8 Apr 2025
- Last updated
- 24 Apr 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT06942273
- Acronym / sponsor ID
- 45/2025
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- University of MalagaUniversity, hospital or other
- Study start
- 1 May 2025 (estimated)
- Primary completion
- 31 Oct 2025 (estimated)
- Study completion
- 30 Apr 2026 (estimated)
- First posted
- 24 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Have a diagnosis confirmed by performing an electromyography of Carpal Tunnel Syndrome
- Have not yet received physiotherapy treatment.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| hyperthermiahyperthermia over the carpal tunnel area and adjacent areas | Radiation | Hyperthermia 2 times per week, Hyperthermia 3 times per week |
| physical exercisePerforming therapeutic physical exercise focused on the flexor muscles of the hand and neural stretching | Other | Hyperthermia 2 times per week, Hyperthermia 3 times per week, Non-hyperthermia 2 times per week, Non-hyperthermia 3 times per week |
| splintimposition of a night splint | Other | Hyperthermia 2 times per week, Hyperthermia 3 times per week, Non-hyperthermia 2 times per week, Non-hyperthermia 3 times per week |
Primary outcome
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
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
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
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
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
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.
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing hyperthermia, physical exercise and splint in people with Carpal Tunnel Syndrome (CTS) and Hyperthermia, run by University of Malaga.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 24 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Boston Carpal Tunnel Syndrome Questionnaire (BCTQ) (time frame: Baseline and up to one year). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2025.