Neuromedulatory Effect of Transcranial Direct Current Electrical Stimulation in Carpal Tunnel Syndrome

Suez Canal University

Status: Unknown

Conditions: Carpal Tunnel Syndrome

Treatments: Device: transcranial direct current electrical stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT03795961

GSMGAEAM

Details and patient eligibility

About

This is a double blinded randomized clinical trial to study the neuromodulatory effect of tDCS in patients with CTS, the study subject will be randomly into two groups; active and sham group , the active group will receive five sessions of active TDCS over the M1 while the Sham group will receive sham tDCS in which the device will be turned off after 30 seconds. The patient will be assessed by VAS score, Boston carpal tunnel questionnaire , central sensetization inventory , pressure pain threshold, sensory and pain threshold for electerical stimulation before , after the end of the sessions and 4 weeks later.

Full description

The study will be carried out on patients attending the Physical Medicine, Rheumatology and Rehabilitation outpatient clinic in Suez Canal University Hospital, Ismailia, EGYPT and diagnosed with CTS according to clinical examination and to the American Association of Neuromuscular and Electrodiagnostic Medicine (AANEM) practice recommendations for CTS.

Study subjects will be divided into two groups:

Group (1): (active group) will include 42 patients with CTS and will receive anodal tDCS of M1 for 20 minutes, at 2 mA for 5 sessions and less than 72 hrs. may be allowed between experimental sessions for each participant to avoid any interference.

Group (2): (sham group) will include 42 patients with CTS and will receive sham tDCS M1 (the set will be turned off after 30 seconds) for 20 minutes, at 2 mA for 5 sessions.

The study sample will be collected from all patients with CTS attending to the Physical medicine, Rheumatology and Rehabilitation outpatient clinic in Suez Canal University Hospital fulfilling the eligibility criteria, will be eligible to join the study (either referred for electrophysiological study or presented to the clinic for primary assessment). To make sure that no bias should enter the assessment of the results, neither the patient nor the clinicians will be aware whether active tDCS will be applicated to a particular case. To ensure this result, two symbols (Square and Triangle) will be applicated to the physiotherapy sheet and only the physiotherapist knew the key for each symbol. The triangle may represent the cases of CTS for active tDCS and the square may represent the sham group or vice versa. At the end of the study the two groups will be revealed in order to analyze the results according to proper statistical measures.

Enrollment: 84 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Patient diagnosed as CTS by history, clinical examination and NCS for more than 3 months.

Both genders. Adult of aged 18 years and above. Able to understand the informed consent.

Exclusion criteria

Patients with diabetes mellitus, collagen disorders, thyroid disease, peripheral neuropathy, traumatic nerve injury, cervical radiculopathy, fibromyalgia.

Pregnancy. Malignant. Patients with any clinically significant or unstable medical or psychiatric disorder.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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84 participants in 2 patient groups

Active tDCS group

Experimental group

Description:

This group will include 42 patients with CTS Intervention (active transcranial direct current electrical stimulation) Stimulation site (M1) Stimulation mode (anodal) Duration of session (20 minutes) Stimulation intensity (2 mA) Number of sessions (5 sessions) Intervals (every another day)

Treatment:

Device: transcranial direct current electrical stimulation

Sham tDCS group

Sham Comparator group

Description:

This group will include 42 patients with CTS Intervention (sham or inactive transcranial direct current electrical stimulation) Stimulation site (M1) Stimulation mode (anodal) Duration of session (20 minutes) Stimulation intensity (2 mA) Number of sessions (5 sessions) Intervals (every another day)

Treatment:

Device: transcranial direct current electrical stimulation