- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07356648
Diadynamic Current and Carpal Tunnel Syndrome
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.
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 Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Düzce, Turkey (Türkiye)
- Duzce University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Clinically and electrophysiologically diagnosed with carpal tunnel syndrome (CTS)
- Provision of informed consent
- Age between 18 and 65 years
Exclusion Criteria:
- 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
- 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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Group 1: Diadynamic Current Plus Splint
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. |
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. |
|
Active Comparator: Group 2: Splint-Only Group
In individuals with carpal tunnel syndrome, splinting is routinely prescribed as a first-line conservative treatment.
|
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.
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Baseline and 6 weeks
|
|
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.
|
Baseline and 6 weeks
|
|
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.
|
Baseline and 6 weeks
|
|
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.
|
Baseline and 6 weeks
|
|
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. |
Baseline and 6 weeks
|
|
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. |
Baseline and 6 weeks
|
|
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. |
Baseline and 6 weeks
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General 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.
- Koca 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neurologic Manifestations
- Nervous System Diseases
- Wounds and Injuries
- Neuromuscular Diseases
- Peripheral Nervous System Diseases
- Median Neuropathy
- Mononeuropathies
- Nerve Compression Syndromes
- Cumulative Trauma Disorders
- Sprains and Strains
- Pathological Conditions, Signs and Symptoms
- Signs and Symptoms
- Pain
- Carpal Tunnel Syndrome
Other Study ID Numbers
- Decision No: 2025/69
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Carpal Tunnel Syndrome (CTS)
-
Issa, Abdulhamid Sayed, M.D.CompletedCarpal Tunnel Syndrome | CTS | Carpal Tunnel Release | Carpal Tunnel Surgery | Carpal Tunnel Transverse ApproachSyrian Arab Republic
-
Ankara UniversityNot yet recruitingCarpal Tunnel Syndrome (CTS)Turkey (Türkiye)
-
Afyonkarahisar Health Sciences UniversityRecruitingCarpal Tunnel Syndrome (CTS)Turkey (Türkiye)
-
Assiut UniversityNot yet recruiting
-
Sohag UniversityNot yet recruitingCarpal Tunnel Syndrome (CTS)Egypt
-
ElsanRecruiting
-
Benha UniversityCompletedSimultaneous vs. Postponed Carpal Tunnel Release (CTR) During Distal Radius Fracture (DRF) Fixation.Carpal Tunnel Syndrome (CTS)Egypt
-
Da Nang Family General HospitalEnrolling by invitation
-
Dr. Nafiz Korez Sincan State HospitalCompletedCarpal Tunnel Syndrome (CTS)Turkey (Türkiye)
-
Galala UniversityCompletedCarpal Tunnel Syndrome (CTS)Egypt
Clinical Trials on Diadynamic Current
-
University of Nove de JulhoCompletedShoulder Impingement SyndromeBrazil
-
University of Sao PauloUnknownEffectiveness of Physical Therapy Treatments of Myofascial Trigger Points in Subjects With Neck PainNeck Pain | Myofascial Pain SyndromeBrazil
-
University of BrasiliaCompleted
-
Anhui Medical UniversityUnknownMajor Depressive Disorder | Transcranial Direct Current Stimulation | Event-Related PotentialsChina
-
Federal University of Rio Grande do SulCompletedHealthy Young | Electric Stimulation TherapyBrazil
-
Brugmann University HospitalCompleted
-
Pamukkale UniversityCompleted
-
Ege UniversityCompleted
-
University of HailCompletedTrigger Point PainSaudi Arabia