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MagnetotherapyNCT07435961

Magnetotherapy in Carpal Tunnel Syndrome: Randomized Controlled Study

A study testing Arm 1: Active Magnetotherapy Group in people with Magnetotherapy and Carpal Tunnel Syndrome (CTS), run by Fatih Sultan Mehmet Training and Research Hospital at 1 site in Turkey (Türkiye).

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

This study is designed to investigate the effectiveness of low-frequency pulsed electromagnetic field therapy in individuals diagnosed with mild-to-moderate carpal tunnel syndrome (CTS). Read more about this study

Who is it for?
Ages 18 to 65 years
What is being tested?
Arm 1: Active Magnetotherapy Group
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
60 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Feb 2026to 1 Nov 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 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Adults aged between 18 and 65 years.
  • Clinical diagnosis of carpal tunnel syndrome (CTS) based on physical examination findings, including positive Tinel and/or Phalen tests and hypoesthesia in the 3rd to 5th digits.
  • Electrophysiologically confirmed mild-to-moderate carpal tunnel syndrome based on electromyography (EMG) findings.

Who cannot join

  • Severe carpal tunnel syndrome confirmed electrophysiologically by electromyography (EMG).
  • History of previous surgical intervention for carpal tunnel syndrome.
  • Presence of other peripheral nerve entrapments (e.g., ulnar nerve entrapment, radial nerve entrapment).
  • Electrophysiologically confirmed polyneuropathy or cervical radiculopathy/cervical discopathy.
  • Rheumatologic diseases (e.g., rheumatoid arthritis, systemic lupus erythematosus).
  • Diabetes mellitus (Type 1 or Type 2).
Show all 17Show fewer
  • Pregnancy.
  • Presence of electronic implants such as cardiac pacemaker, cochlear implant, or implantable defibrillator.
  • Active acute infection.
  • History of malignancy.
  • Receipt of physical therapy or rehabilitation for the wrist or surrounding area within the past 6 months.
  • Corticosteroid injection to the wrist within the past 6 months.
  • Hyperthyroidism or adrenal gland hyperfunction.
  • Open growth plates (epiphyseal plates not closed).
  • Paroxysmal neurological disorders (e.g., epilepsy).
  • Myasthenia gravis.
  • Regular use of pain medications such as pregabalin, duloxetine, or non-steroidal anti-inflammatory drugs (NSAIDs).

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Orçun Ünalan, medical doctor contact

+905337335856

orcununalan@gmail.com

Pınar Akpınar, medical doctor contact

+905057877442

pinar.pinarakpinar@gmail.com

Turkey (Türkiye)1 site
  • Fatih Sultan Mehmet Research and Training Hospital

    Istanbul, Istanbul, 34734

    Orçun Ünalan, medical doctor, +905337335856, orcununalan@gmail.com

    Orçun Ünalan, MD

Other trials in Turkey (Türkiye)

About this study

Official title: Evaluation of the Effectiveness of Magnetotherapy in Patients With Carpal Tunnel Syndrome: A Placebo-Controlled, Triple-Arm, Randomized, Double-Blind Study

This study is designed to investigate the effectiveness of low-frequency pulsed electromagnetic field therapy in individuals diagnosed with mild-to-moderate carpal tunnel syndrome (CTS). This double-blind, randomized controlled trial will randomly assign participants into three groups:

Group 1: Active magnetotherapy

Read more

Group 2: Placebo magnetotherapy (treatment using an identical device that does not generate a magnetic field)

Group 3: Routine (conservative) treatment group

All participants will receive a standard nighttime wrist splint and a standardized nerve and tendon gliding exercise protocol. Magnetic field applications will be administered five days per week for a total of 15 sessions. Assessments will be conducted at baseline (T0), at the end of treatment (T1 - Week 3), at 1 month (T2), and at 3 months (T3).

The primary outcome measures include the Boston Carpal Tunnel Questionnaire (BCTQ), pain intensity assessed by the Visual Analog Scale (VAS), functional status measured by QuickDASH, median nerve cross-sectional area assessed by ultrasonography, sensory function evaluated using the Semmes-Weinstein monofilament test, grip strength measured by dynamometry, and clinical test results (Tinel and Phalen tests). Secondary outcomes include sleep quality assessed by the Pittsburgh Sleep Quality Index (PSQI) and patient satisfaction.

This study aims to contribute to the scientific evidence regarding the effectiveness of magnetotherapy as a non-invasive treatment option for carpal tunnel syndrome.

Read the detailed description

Carpal tunnel syndrome (CTS) is a common entrapment neuropathy caused by compression of the median nerve within the carpal tunnel at the wrist, resulting in symptoms such as tingling, numbness, pain, and functional impairment in the hand and fingers. According to the American Association of Neuromuscular and Electrodiagnostic Medicine (AANEM), the diagnosis is supported electrophysiologically by delayed distal motor or sensory conduction, conduction block, or prolonged response latency of the median nerve. Clinically, CTS presents with paresthesia, pain, numbness, and functional limitations. The condition is more prevalent among middle-aged individuals, particularly office workers, homemakers, and those engaged in repetitive wrist movements. If left untreated, CTS may lead to muscle weakness and a significant decline in quality of life.

Conservative treatment options include nighttime wrist splinting, nerve mobilization exercises, pharmacological therapy, and physical therapy modalities. However, these approaches are generally symptom-oriented and may have limited long-term effectiveness.

Magnetotherapy has emerged as a non-invasive physical therapy modality with minimal side effects. Pulsed electromagnetic field (PEMF) therapy has been reported to reduce pain and improve objective nerve function in refractory CTS cases in both short- and long-term follow-up. Nevertheless, scientific evidence regarding the effectiveness of magnetotherapy in CTS remains limited, and many existing studies lack robust methodological designs such as placebo control, randomization, and blinding. Therefore, this study aims to contribute to the current literature and strengthen clinical decision-making by providing high-quality evidence on the effectiveness of magnetotherapy in CTS.

Being tested
Arm 1: Active Magnetotherapy Group, Arm 2: Sham (Placebo) Magnetotherapy Group, Arm 3: Conservative Treatment (Wait-List Control) Group
Keywords
median nerve compression, carpal tunnel syndrome(cts), magnetotherapy
Medical subject headings
Carpal Tunnel Syndrome, Median Neuropathy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Arm 1: Active Magnetotherapy GroupDevice

    Participants assigned to this group will receive active pulsed electromagnetic field (PEMF) therapy administered five days per week for three consecutive weeks, totaling 15 treatment sessions. Each session will last 15-20 minutes. The treatment will be delivered using a clinically approved medical device set at a frequency of 50 Hz and a magnetic field intensity of 2-3 millitesla (mT). The application will be performed in a controlled clinical setting by trained healthcare personnel.

    In addition to magnetotherapy, all participants in this group will receive standard conservative treatment, including the use of a neutral-position wrist splint during nighttime and a standardized home-based exercise program consisting of nerve gliding and tendon gliding exercises. Participants will be instructed on proper exercise performance and adherence will be monitored throughout the study period.

  • Arm 2: Sham (Placebo) Magnetotherapy GroupDevice

    Participants in this group will undergo a sham magnetotherapy procedure using the same device, with identical appearance, positioning, session duration, and application protocol as the active treatment group. However, the device will be set to a mode that does not generate a magnetic field. This approach is designed to maintain participant blinding and control for placebo effects.

    Similar to the active group, participants will receive standard conservative treatment consisting of nighttime wrist splint use and the same standardized nerve and tendon gliding home exercise program. Exercise instructions and compliance monitoring will be identical to those of the active treatment group.

  • Arm 3: Conservative Treatment (Wait-List Control) GroupOther

    Participants in this group will receive standard conservative management only, including nighttime wrist splinting and the standardized home-based nerve and tendon gliding exercise program. No magnetotherapy device will be applied during the study period.

    To ensure ethical considerations, participants in this group will be placed on a wait-list and may be offered magnetotherapy after completion of the follow-up assessments. Compliance with splint use and exercise performance will be monitored similarly to the other groups.

Study groups in NCT07435961
Study groupRoleWhat they receive
Group 1 (Magnetotherapy Group):Active comparatorParticipants will receive pulsed magnetotherapy five days per week for a total of 15 sessions. Treatment parameters will be 50 Hz frequency, 2-3 mT magnetic field intensity, and 15-20 minutes per session. In addition, participants in this group will use a standard nighttime wrist splint and follow a standardized home exercise program consisting of nerve and tendon gliding exercises.
Receives: Device: Arm 1: Active Magnetotherapy Group
Group 2 (Placebo Magnetotherapy Group)Sham comparatorParticipants will receive treatment using the same device, with identical appearance and session duration; however, the device will not generate a magnetic field (sham mode). Participants in this group will also use a standard nighttime wrist splint and follow the same standardized home exercise program (nerve and tendon gliding exercises).
Receives: Device: Arm 2: Sham (Placebo) Magnetotherapy Group
Group 3 (Routine/Conservative Treatment Group)OtherParticipants in this group will use a standard nighttime wrist splint and follow the standardized home exercise program (nerve and tendon gliding exercises). These participants will be placed on a wait-list for magnetotherapy.
Receives: Other: Arm 3: Conservative Treatment (Wait-List Control) Group

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Symptom Severity Assessed by Boston Carpal Tunnel Questionnaire Symptom Severity Scale

    The Boston Carpal Tunnel Questionnaire Symptom Severity Scale is an 11-item patient-reported outcome measure assessing the severity and frequency of carpal tunnel syndrome symptoms. Each item is scored from 1 (no symptoms) to 5 (most severe symptoms). The final score is calculated as the mean of all items, ranging from 1 to 5. Higher scores indicate more severe symptoms and worse clinical outcome.

    Measured: Baseline (Week 0), Week 3, Month 1, Month 3

  2. Wrist Pain Intensity Assessed by Visual Analog Scale

    Pain intensity will be measured using a 10-centimeter Visual Analog Scale. The scale ranges from 0 to 10, where 0 indicates "no pain" and 10 indicates "worst imaginable pain." Higher scores indicate greater pain severity and worse outcome.

    Measured: Baseline (Week 0), Week 3, Month 1, Month 3

  3. Upper Extremity Function Assessed by Quick Disabilities of the Arm, Shoulder and Hand Questionnaire

    Upper extremity function will be assessed using the Quick Disabilities of the Arm, Shoulder and Hand Questionnaire. This 11-item validated questionnaire is scored on a 5-point Likert scale and transformed to a total score ranging from 0 to 100. A score of 0 represents no disability and 100 represents maximum disability. Higher scores indicate worse functional impairment.

    Measured: Baseline (Week 0), Week 3, Month 1, Month 3

  4. Hand Grip Strength Assessed by Jamar Dynamometer

    Hand grip strength will be measured using a calibrated Jamar dynamometer and recorded in kilograms (kg). Higher values indicate greater muscle strength and better functional outcome.

    Measured: Baseline (Week 0), Week 3, Month 1, Month 3

  5. Sensory Function Assessed by Semmes-Weinstein Monofilament Test

    Sensory function will be evaluated using the Semmes-Weinstein Monofilament Test. Calibrated monofilaments of different thicknesses are applied to standardized fingertip locations to determine sensory threshold levels. Monofilament values range from lower to higher force levels. Higher threshold values indicate greater sensory impairment, whereas lower threshold values indicate better sensory function.

    Measured: Baseline (Week 0), Week 3, Month 1, Month 3

  6. Median Nerve Cross-Sectional Area Assessed by Ultrasonography

    The cross-sectional area of the median nerve will be measured at the carpal tunnel inlet using high-resolution ultrasonography. Values are recorded in square millimeters (mm²). Higher cross-sectional area values indicate greater nerve swelling and worse pathological status.

    Measured: Baseline (Week 0), Week 3, Month 1, Month 3

  7. Clinical Signs Assessed by Tinel and Phalen Tests

    The presence or absence of positive Tinel and Phalen signs will be recorded. A positive test indicates median nerve irritation. A reduction in the proportion of positive tests indicates clinical improvement.

    Measured: Baseline (Week 0), Week 3, Month 1, Month 3

Secondary outcomes (2)
  1. Sleep Quality Assessed by Pittsburgh Sleep Quality Index

    Sleep quality will be assessed using the Pittsburgh Sleep Quality Index. The total global score ranges from 0 to 21. Higher scores indicate poorer sleep quality and worse outcome.

    Measured: Baseline (Week 0), Week 3, Month 1, Month 3

  2. Patient Satisfaction Assessed by 5-Point Likert Scale

    Patient satisfaction will be assessed using a 5-point Likert scale ranging from 1 (very dissatisfied) to 5 (very satisfied). Higher scores indicate greater satisfaction and better perceived treatment outcome.

    Measured: Week 3 (End of Treatment)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Feb 2026
  2. Study start1 Feb 2026 (estimated)
  3. Primary completion1 Jun 2026 (estimated)
  4. Study completion1 Nov 2026 (estimated)

Resources

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
Model description
Prospective, Randomized, Placebo-Controlled, Double-Blind Study
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07435961
Sponsor's protocol ID
CTS-MGNT
Status last verified
Feb 2026
First submitted
17 Feb 2026
Last updated
27 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Individual participant data (IPD) will not be shared publicly. All collected data will be de-identified and analyzed for scientific publication purposes only.

Questions about this trial

What is this clinical trial studying?

A study testing Arm 1: Active Magnetotherapy Group in people with Magnetotherapy and Carpal Tunnel Syndrome (CTS), run by Fatih Sultan Mehmet Training and Research Hospital at 1 site in Turkey (Türkiye).

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 3 inclusion and 17 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 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?

Contact Orçun Ünalan, medical doctor (+905337335856, orcununalan@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Symptom Severity Assessed by Boston Carpal Tunnel Questionnaire Symptom Severity Scale (time frame: Baseline (Week 0), Week 3, Month 1, Month 3). The study lists 7 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 27 Feb 2026.

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