Investigation of the Effectiveness of Diadynamic Current in Patients With Carpal Tunnel Syndrome
Phase: NA
Conditions: Carpal Tunnel Syndrome (CTS)
Sponsor: Duzce University

STUDY PROTOCOL (Cover Page) 
Official Title: Investigation of the Effectiveness of Diadynamic 
Current Therapy in Patients with Carpal Tunnel Syndrome 
ClinicalTrials.gov Identifier: Not yet assigned 
Document Date: 24 March 2025 
Sponsor: Duzce University Faculty of Medicine 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

STUDY PROTOCOL 
Title 
Investigation of the Effectiveness of Diadynamic Current Therapy in Patients With Carpal 
Tunnel Syndrome 
1. Background and Rationale 
Carpal tunnel syndrome (CTS), first described by Paget in 1854, is the most common 
entrapment neuropathy of the upper extremity. It results from compression of the median 
nerve within the carpal tunnel and is characterized by pain, numbness, tingling, and functional 
impairment of the hand. In patients with mild to moderate CTS, conservative, non-surgical 
treatment approaches are preferred as the first-line therapy. 
Conservative treatment options include patient education, tendon and median nerve gliding 
exercises, splint use, physical therapy modalities, kinesiotaping, manual therapy techniques, 
injection therapies, and oral medical treatments. Initial treatment typically consists of patient 
education, exercise programs, and the use of wrist splints that maintain the wrist in a neutral 
position. 
Tendon and median nerve gliding exercises play an important role in the conservative 
management of CTS. Randomized controlled studies have demonstrated that these exercises 
contribute to symptom reduction and functional improvement. Splint use is recommended at 
all stages of CTS, with night-time neutral-position wrist splints being the most commonly 
preferred option. 
Diadynamic currents (DDC) are thought to have a composite analgesic mechanism primarily 
explained by the gate control theory. It is suggested that DDC affects both sensory and motor 
nerves and may increase endorphin release, thereby producing an analgesic effect. Some 
studies have reported that the analgesic effectiveness of DDC may be greater than that of 
transcutaneous electrical nerve stimulation (TENS). Although TENS is more commonly used 
in physical therapy practice, DDC may represent a realistic alternative for clinical pain 
management. 
2. Study Objectives 
The primary objective of this study is to evaluate the effects of diadynamic current therapy on 
clinical 
symptoms 
in 
patients 
diagnosed 
with 
carpal 
tunnel 
syndrome. 
The secondary objective is to investigate the effects of diadynamic current therapy on 
electrophysiological findings of the median nerve. 
3. Study Population 
3.1 Inclusion Criteria 

1. Clinically and electrophysiologically diagnosed with carpal tunnel syndrome 
2. Voluntary participation with written informed consent 
3. Aged between 18 and 65 years 
3.2 Exclusion Criteria 
1. Age below 18 or above 65 years 
2. Median nerve distal motor latency longer than 6.0 ms on nerve conduction studies 
(NCS) 
3. Presence of thenar muscle atrophy 
4. History of surgery for carpal tunnel syndrome 
5. History of steroid injection into the carpal tunnel 
6. History of physical therapy for CTS within the last 6 months 
7. Presence of cervical radiculopathy 
8. Tenosynovitis in the ipsilateral upper extremity 
9. Another compressive neuropathy in the ipsilateral upper extremity 
10. Peripheral polyneuropathy 
11. History of trauma or fracture involving the hand, wrist, or forearm 
12. Active pregnancy 
13. Presence of metabolic disease 
14. Inflammatory rheumatic disease 
15. Acute and/or chronic renal failure 
16. Severe cognitive impairment preventing understanding and following simple 
instructions 
17. Severe visual or hearing impairment preventing participation in treatment 
18. Current use of pregabalin or gabapentin 
19. Presence of systemic diseases (e.g., diabetes mellitus, hypothyroidism, rheumatic 
diseases) 
4. Study Design and Methods 
This prospective controlled study is planned to be conducted between April 15, 2025, and 
October 15, 2025, at the Department of Physical Medicine and Rehabilitation, Duzce 
University Faculty of Medicine Research and Application Hospital. 
Demographic data including age, sex, height, weight, dominant hand, marital status, 
educational level, occupation, and duration of employment will be recorded. Information 
regarding the affected hand, type and duration of symptoms, daily symptom patterns, 

comorbid diseases, history of trauma or surgery, previous CTS treatments within the last six 
months, smoking and alcohol use, and pregnancy status will be collected. 
Patients clinically diagnosed with CTS will routinely undergo nerve conduction studies (NCS) 
at the Electromyography Laboratory of the Department of Neurology, Duzce University 
Faculty of Medicine. Patients with electrophysiological findings consistent with mild to 
moderate CTS will be included in the study. 
5. Study Groups and Interventions 
Participants will be allocated into two groups: 
Group 
Exercise Program Splint Use Additional Treatment 
DDC Group 
Home program 
Night-time Diadynamic current (10 sessions) 
Control Group Home program 
Night-time None 
All participants will receive patient education and written and visual instructions on tendon 
and median nerve gliding exercises. Both groups will be instructed to perform the exercises 
daily for 12 weeks, consisting of 6 sets (30 repetitions) per day. 
5.1 Diadynamic Current (DDC) Application 
Diadynamic current therapy will be applied to the palmar surface of the hand and the volar 
surface of the forearm using 6 × 6 cm carbon electrodes as follows: 
 
Diphase fixe (DF): 2 minutes 
 
Monophase fixe (MF): 3 minutes 
 
Longues periodes (LP): 3 minutes 
 
Courtes periodes (CP): 2 minutes 
Total application time will be 10 minutes. The treatment parameters and sequence will be 
based on Bernard’s current methodology. 
5.2 Splint Application 
Both groups will be provided with a resting wrist splint maintaining the wrist in a neutral 
position. Participants will be instructed to wear the splint every night before bedtime and 
remove it in the morning. 
6. Outcome Measures and Follow-up 
Participants will be evaluated twice: at baseline (pre-treatment) and at the 6th week of 
treatment. 
Outcome Measures 
Parameter 
Assessment Method 
Pain and numbness 
Visual Analog Scale (VAS), BCTQ-SSS 

Functional status 
BCTQ-FSS 
Hand grip strength 
Hand dynamometer 
Pinch strength 
Pinch meter 
Median nerve involvement Nerve conduction studies (NCS) 
BCTQ-SSS: Boston Carpal Tunnel Questionnaire – Symptom Severity Scale  
BCTQ-FSS: Boston Carpal Tunnel Questionnaire – Functional Status Scale 
7. Concomitant Medication 
During the study period, except on assessment days, participants will be allowed to use 
paracetamol for pain relief when necessary, with a maximum dose of 1 g/day. 
8. Ethical Considerations and Safety 
This study will be conducted in accordance with the principles of the Declaration of Helsinki. 
Approval was obtained from the Düzce University Non-Interventional Health Research Ethics 
Committee on 24 March 2025, Decision No. 2025/69. Written informed consent will be 
obtained from all participants prior to enrollment.