Carpal Tunnel Syndrome (CTS)NCT07356648
Diadynamic Current and Carpal Tunnel Syndrome
A study testing Diadynamic Current and Wrist Splint in people with Carpal Tunnel Syndrome (CTS), run by Duzce University at 1 site in Turkey (Türkiye).
Trial summary
Carpal tunnel syndrome (CTS), first described by Paget in 1854, is the most common entrapment neuropathy. Conservative treatment approaches are prioritized in patients with mild to moderate CTS. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Carpal Tunnel Syndrome (CTS)
- What is being tested?
- Diadynamic Current and Wrist Splint
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 21 Apr 2025to 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Clinically and electrophysiologically diagnosed with carpal tunnel syndrome (CTS)
- Provision of informed consent
- Age between 18 and 65 years
Who cannot join
- Age below 18 years or above 65 years
- Median nerve distal motor latency > 6.0 ms on nerve conduction studies (NCS)
- Thenar muscle atrophy
- History of carpal tunnel syndrome surgery
- History of steroid injection into the carpal tunnel
- History of physical therapy for CTS within the past 6 months
Show all 19Show fewer
- Cervical radiculopathy
- Tenosynovitis in the ipsilateral upper extremity
- Other compressive neuropathy in the ipsilateral upper extremity
- Peripheral polyneuropathy
- History of trauma or fracture involving the hand, wrist, or forearm
- Pregnancy
- Presence of metabolic disease
- Inflammatory rheumatic disease
- Acute and/or chronic renal failure
- Severe cognitive impairment preventing understanding and following simple instructions
- Severe visual or hearing impairment preventing participation in treatment
- Current use of pregabalin or gabapentin
- Systemic diseases (e.g., diabetes mellitus, hypothyroidism, rheumatic diseases)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation of the Effectiveness of Diadynamic Current in Patients With Carpal Tunnel Syndrome
Carpal tunnel syndrome (CTS), first described by Paget in 1854, is the most common entrapment neuropathy. Conservative treatment approaches are prioritized in patients with mild to moderate CTS. Conservative management includes education, tendon and median nerve gliding exercises, physical therapy modalities, kinesiotaping, manual therapy techniques, injection options, and oral medical treatments. First-line treatment generally consists of education, exercise, and splinting.
Tendon and median nerve gliding exercises represent key components of conservative treatment. Splinting is recommended at all stages of CTS, with wrist splints designed to maintain a neutral position being the most commonly preferred option. The prevailing approach in the literature supports the use of splints primarily during nighttime.
Read more
Diadynamic current (DDC) is considered to have a composite analgesic mechanism, primarily explained by the gate control theory. Additional mechanisms suggest that DDC affects both sensory and motor nerves and may increase endorphin release, contributing to pain relief. A single treatment session typically does not exceed 12 minutes. Some studies indicate that the analgesic effect of DDC may be greater than that of transcutaneous electrical nerve stimulation (TENS). Although TENS is widely used in physical therapy and rehabilitation practice, DDC may represent a realistic alternative for clinical pain management.
The aim of the study is to evaluate the effect of diadynamic current therapy on clinical symptoms in patients with CTS and to investigate its impact on electrophysiological findings of the median nerve.
- Conditions
- Carpal Tunnel Syndrome (CTS)
- Being tested
- Diadynamic Current, Wrist Splint
- Keywords
- Carpal Tunnel Syndrome, Diadynamic Current, Electrotherapy, Pain
- Medical subject headings
- Carpal Tunnel Syndrome, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diadynamic CurrentProcedure or surgery
Diadynamic current (DDC) is a routine therapeutic modality applied in the physical medicine and rehabilitation clinic to alleviate symptoms in various conditions. In individuals with carpal tunnel syndrome (CTS), DDC is routinely administered in cases where sufficient benefit is not achieved with splinting and transcutaneous electrical nerve stimulation (TENS).
For this purpose, diadynamic current is applied to the palmar surface of the hand and the volar surface of the forearm using equal-sized carbon electrodes (6 × 6 cm). A sequence of different types of diadynamic currents is administered for a total duration of 10 minutes as follows: diphase fixe (DF) for 2 minutes, monophase fixe (MF) for 3 minutes, longues périodes (LP) for 3 minutes, and courtes périodes (CP) for 2 minutes.
The treatment duration, parameters, and sequence of diadynamic currents are based on Bernard's current methodology and are identical to the procedure described by Ratajczak et al.
Wrist SplintProcedure or surgery
In individuals with carpal tunnel syndrome, splinting is routinely prescribed as a first-line conservative treatment. A resting wrist splint extending from the distal forearm to the hand and maintaining the wrist in a neutral position is provided to both groups. The splint is worn every night before bedtime, maintained throughout the night, and removed in the morning upon waking.
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Diadynamic Current Plus Splint | Experimental | Diadynamic current (DDC) is a routine physical therapy modality applied in the physical medicine and rehabilitation clinic to reduce symptoms in various conditions. In individuals with carpal tunnel syndrome (CTS), splinting is routinely prescribed as a first-line conservative treatment. In addition, physical therapy modalities such as DDC are applied in cases where adequate benefit is not achieved with splint therapy alone.
Since splinting is provided as the initial conservative treatment in routine clinical practice, no delay or loss of treatment time occurs. Individuals receiving splint therapy are informed about DDC treatment, and those providing consent for 10 physical therapy sessions are allocated to the DDC group. Receives: Procedure: Diadynamic Current |
| Group 2: Splint-Only Group | Active comparator | In individuals with carpal tunnel syndrome, splinting is routinely prescribed as a first-line conservative treatment. Receives: Procedure: Diadynamic Current; Procedure: Wrist Splint |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Boston Carpal Tunnel Questionnaire Symptom Severity Scale Score
Boston Carpal Tunnel Questionnaire - Symptom Severity Scale (BCTQ-SSS) is a patient-reported outcome measure assessing symptom severity in individuals with carpal tunnel syndrome. Scores range from 1 to 5, with higher scores indicating worse symptom severity.
Measured: Baseline and 6 weeks
Change from Baseline in Boston Carpal Tunnel Questionnaire Functional Status Scale Score
Boston Carpal Tunnel Questionnaire - Functional Status Scale (BCTQ-FSS) assesses functional status and difficulty in daily activities in individuals with carpal tunnel syndrome. Scores range from 1 to 5, with higher scores indicating worse functional status.
Measured: Baseline and 6 weeks
Change from Baseline in Hand Grip Strength (kg)
Hand Grip Strength was measured using a Saehan SH5001 Hydraulic Hand Dynamometer and recorded in kg. Higher values indicate greater grip strength.
Measured: Baseline and 6 weeks
Change from Baseline in Pinch Grip Strength (kg)
Pinch Grip Strength was measured using a Saehan SH5005-1 Mechanical Pinch Gauge and recorded in kg. Higher values indicate greater pinch strength.
Measured: Baseline and 6 weeks
Electrophysiological Assessment-Median Distal Motor Latency
Median distal motor latency was evaluated using nerve conduction studies (NCS) performed at the Electromyography Laboratory of the Department of Neurology, Düzce University Faculty of Medicine. Measurements were recorded in milliseconds (ms).
Electrophysiological carpal tunnel syndrome was defined as median distal motor latency ≥ 4.0 ms.
Measured: Baseline and 6 weeks
Electrophysiological Assessment- Median Sensory Nerve Conduction Velocity
Median sensory nerve conduction velocity was evaluated using nerve conduction studies (NCS) performed at the Electromyography Laboratory of the Department of Neurology, Düzce University Faculty of Medicine. Measurements were recorded in meters per second (m/s).
Electrophysiological carpal tunnel syndrome was defined as median sensory nerve conduction velocity ≤ 40 m/s.
Measured: Baseline and 6 weeks
Electrophysiological Assessment-Median-Ulnar Sensory Peak Latency Difference
Comparative median-ulnar sensory peak latency analysis was performed using fourth-digit recordings with wrist stimulation during nerve conduction studies (NCS). Measurements were recorded in milliseconds (ms).
Electrophysiological carpal tunnel syndrome was defined as median sensory peak latency from the fourth digit exceeding ulnar latency by ≥ 0.4 ms.
Measured: Baseline and 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2026
- Study start21 Apr 2025
- Primary completion15 Dec 2025
- Study completionApr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Duzce University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07356648
- Sponsor's protocol ID
- Decision No: 2025/69
- Status last verified
- Jan 2026
- First submitted
- 23 Dec 2025
- Last updated
- 21 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Demidas A, Zarzycki M. Touch and Pain Sensations in Diadynamic Current (DD) and Transcutaneous Electrical Nerve Stimulation (TENS): A Randomized Study. Biomed Res Int. 2019 Jul 17;2019:9073073. doi: 10.1155/2019/9073073. eCollection 2019.
PubMed 31380442Koca I, Boyaci A, Tutoglu A, Ucar M, Kocaturk O. Assessment of the effectiveness of interferential current therapy and TENS in the management of carpal tunnel syndrome: a randomized controlled study. Rheumatol Int. 2014 Dec;34(12):1639-45. doi: 10.1007/s00296-014-3005-3. Epub 2014 Apr 12.
PubMed 24728028
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effectiveness of Diadynamic Current in Patients With Carpal Tunnel Syndrome
- ClinicalTrials.gov ID
- NCT07356648
- Acronym / sponsor ID
- Decision No: 2025/69
- Conditions
- Carpal Tunnel Syndrome (CTS)
- Keywords
- Carpal Tunnel Syndrome, Diadynamic Current, Electrotherapy, Pain
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Duzce UniversityUniversity, hospital or other
- Study start
- 21 Apr 2025 (actual)
- Primary completion
- 15 Dec 2025 (actual)
- Study completion
- Apr 2026 (estimated)
- First posted
- 21 Jan 2026 (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.
Carpal tunnel syndrome (CTS), first described by Paget in 1854, is the most common entrapment neuropathy. Conservative treatment approaches are prioritized in patients with mild to moderate CTS. Conservative management includes education, tendon and median nerve gliding exercises, physical therapy modalities, kinesiotaping, manual therapy techniques, injection options, and oral medical treatments. First-line treatment generally consists of education, exercise, and splinting.
Tendon and median nerve gliding exercises represent key components of conservative treatment. Splinting is recommended at all stages of CTS, with wrist splints designed to maintain a neutral position being the most commonly preferred option. The prevailing approach in the literature supports the use of splints primarily during nighttime.
Diadynamic current (DDC) is considered to have a composite analgesic mechanism, primarily explained by the gate control theory. Additional mechanisms suggest that DDC affects both sensory and motor nerves and may increase endorphin release, contributing to pain relief. A single treatment session typically does not exceed 12 minutes. Some studies indicate that the analgesic effect of DDC may be greater than that of transcutaneous electrical nerve stimulation (TENS). Although TENS is widely used in physical therapy and rehabilitation practice, DDC may represent a realistic alternative for clinical pain management.
The aim of the study is to evaluate the effect of diadynamic current therapy on clinical symptoms in patients with CTS and to investigate its impact on electrophysiological findings of the median nerve.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1: Diadynamic Current Plus Splint | Experimental | Procedure: Diadynamic CurrentDiadynamic current (DDC) is a routine physical therapy modality applied in the physical medicine and rehabilitation clinic to reduce symptoms in various conditions. In individuals with carpal tunnel syndrome (CTS), splinting is routinely prescribed as a first-line conservative treatment. In addition, physical therapy modalities such as DDC are applied in cases where adequate benefit is not achieved with splint therapy alone. Since splinting is provided as the initial conservative treatment in routine clinical practice, no delay or loss of treatment time occurs. Individuals receiving splint therapy are informed about DDC treatment, and those providing consent for 10 physical therapy sessions are allocated to the DDC group. |
| Group 2: Splint-Only Group | Active comparator | Procedure: Diadynamic Current, Procedure: Wrist SplintIn individuals with carpal tunnel syndrome, splinting is routinely prescribed as a first-line conservative treatment. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Clinically and electrophysiologically diagnosed with carpal tunnel syndrome (CTS)
- Provision of informed consent
- Age between 18 and 65 years
Key exclusion criteria (19 listed)
- Age below 18 years or above 65 years
- Median nerve distal motor latency > 6.0 ms on nerve conduction studies (NCS)
- Thenar muscle atrophy
- History of carpal tunnel syndrome surgery
- History of steroid injection into the carpal tunnel
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 |
|---|---|---|
| Diadynamic CurrentDiadynamic current (DDC) is a routine therapeutic modality applied in the physical medicine and rehabilitation clinic to alleviate symptoms in various conditions. In individuals with carpal tunnel syndrome (CTS), DDC is routinely administered in cases where sufficient benefit is not achieved with splinting and transcutaneous electrical nerve stimulation (TENS). For this purpose, diadynamic current is applied to the palmar surface of the hand and the volar surface of the forearm using equal-sized carbon electrodes (6 × 6 cm). A sequence of different types of diadynamic currents is administered for a total duration of 10 minutes as follows: diphase fixe (DF) for 2 minutes, monophase fixe (MF) for 3 minutes, longues périodes (LP) for 3 minutes, and courtes périodes (CP) for 2 minutes. The treatment duration, parameters, and sequence of diadynamic currents are based on Bernard's current methodology and are identical to the procedure described by Ratajczak et al. | Procedure or surgery | Group 1: Diadynamic Current Plus Splint, Group 2: Splint-Only Group |
| Wrist SplintIn individuals with carpal tunnel syndrome, splinting is routinely prescribed as a first-line conservative treatment. A resting wrist splint extending from the distal forearm to the hand and maintaining the wrist in a neutral position is provided to both groups. The splint is worn every night before bedtime, maintained throughout the night, and removed in the morning upon waking. | Procedure or surgery | Group 2: Splint-Only Group |
Primary outcome
Change from Baseline in Boston Carpal Tunnel Questionnaire Symptom Severity Scale Score
Time frame: Baseline and 6 weeks
Boston Carpal Tunnel Questionnaire - Symptom Severity Scale (BCTQ-SSS) is a patient-reported outcome measure assessing symptom severity in individuals with carpal tunnel syndrome. Scores range from 1 to 5, with higher scores indicating worse symptom severity.
Change from Baseline in Boston Carpal Tunnel Questionnaire Functional Status Scale Score
Time frame: Baseline and 6 weeks
Boston Carpal Tunnel Questionnaire - Functional Status Scale (BCTQ-FSS) assesses functional status and difficulty in daily activities in individuals with carpal tunnel syndrome. Scores range from 1 to 5, with higher scores indicating worse functional status.
Change from Baseline in Hand Grip Strength (kg)
Time frame: Baseline and 6 weeks
Hand Grip Strength was measured using a Saehan SH5001 Hydraulic Hand Dynamometer and recorded in kg. Higher values indicate greater grip strength.
Change from Baseline in Pinch Grip Strength (kg)
Time frame: Baseline and 6 weeks
Pinch Grip Strength was measured using a Saehan SH5005-1 Mechanical Pinch Gauge and recorded in kg. Higher values indicate greater pinch strength.
Electrophysiological Assessment-Median Distal Motor Latency
Time frame: Baseline and 6 weeks
Median distal motor latency was evaluated using nerve conduction studies (NCS) performed at the Electromyography Laboratory of the Department of Neurology, Düzce University Faculty of Medicine. Measurements were recorded in milliseconds (ms). Electrophysiological carpal tunnel syndrome was defined as median distal motor latency ≥ 4.0 ms.
Electrophysiological Assessment- Median Sensory Nerve Conduction Velocity
Time frame: Baseline and 6 weeks
Median sensory nerve conduction velocity was evaluated using nerve conduction studies (NCS) performed at the Electromyography Laboratory of the Department of Neurology, Düzce University Faculty of Medicine. Measurements were recorded in meters per second (m/s). Electrophysiological carpal tunnel syndrome was defined as median sensory nerve conduction velocity ≤ 40 m/s.
Electrophysiological Assessment-Median-Ulnar Sensory Peak Latency Difference
Time frame: Baseline and 6 weeks
Comparative median-ulnar sensory peak latency analysis was performed using fourth-digit recordings with wrist stimulation during nerve conduction studies (NCS). Measurements were recorded in milliseconds (ms). Electrophysiological carpal tunnel syndrome was defined as median sensory peak latency from the fourth digit exceeding ulnar latency by ≥ 0.4 ms.
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 21 Jan 2026.
- Results publication: PubMed 31380442Demidas A, Zarzycki M. Touch and Pain Sensations in Diadynamic Current (DD) and Transcutaneous Electrical Nerve Stimulation (TENS): A Randomized Study. Biomed Res Int. 2019 Jul 17;2019:9073073. doi: 10.1155/2019/9073073. eCollection 2019.
- Results publication: PubMed 24728028Koca I, Boyaci A, Tutoglu A, Ucar M, Kocaturk O. Assessment of the effectiveness of interferential current therapy and TENS in the management of carpal tunnel syndrome: a randomized controlled study. Rheumatol Int. 2014 Dec;34(12):1639-45. doi: 10.1007/s00296-014-3005-3. Epub 2014 Apr 12.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diadynamic Current and Wrist Splint in people with Carpal Tunnel Syndrome (CTS), run by Duzce University 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 19 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: under way, not looking for participants, as of the sponsor's last update on 21 Jan 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. 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?
Change from Baseline in Boston Carpal Tunnel Questionnaire Symptom Severity Scale Score (time frame: Baseline and 6 weeks). 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?
On the ClinicalTrials.gov record for NCT07356648, which also lists 2 linked publications.
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 21 Jan 2026.