Clinical trial NCT03795961: Neuromedulatory Effect of Transcranial Direct Current Electrical Stimulation in Carpal Tunnel Syndrome
Official title: Evaluation of The Neuromedulatory Effect of Transcranial Direct Current Electrical Stimulation (tDCS) in Carpal Tunnel Syndrome (CTS): A Double Blinded Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Carpal Tunnel Syndrome
Lead sponsor: Suez Canal University
Sponsor class: OTHER
First posted: 2019-01-08
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: the study subject will be allocated into two group ; active and sham group
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Visual analogue scale
timeFrame: before sessions (baseline assessment)
measure: Visual analogue scale (VAS)
timeFrame: immediately after the ending of sessions
measure: Visual analogue scale (VAS)
timeFrame: four weeks after the ending of sessions
measure: Sensory threshold and pain threshold for electrical stimulation
timeFrame: before sessions (baseline assessment)
measure: Sensory threshold and pain threshold for electrical stimulation
timeFrame: immediately after the ending of sessions
measure: Sensory threshold and pain threshold for electrical stimulation
timeFrame: four weeks after the ending of sessions
measure: Pressure pain threshold assessment
timeFrame: before sessions (baseline assessment)
measure: Pressure pain threshold assessment
timeFrame: immediately after the ending of sessions
measure: Pressure pain threshold assessment
timeFrame: four weeks after the ending of sessions
Secondary outcomes:
measure: Boston carpal tunnel syndrome questionnaire
timeFrame: before sessions (baseline assessment)
measure: Boston carpal tunnel syndrome questionnaire
timeFrame: immediately after the ending of sessions
measure: Boston carpal tunnel syndrome questionnaire
timeFrame: four weeks after the ending of sessions
measure: Central sensitization inventory
timeFrame: before sessions (baseline assessment)
measure: Central sensitization inventory (CSI)
timeFrame: immediately after the ending of sessions
measure: Central sensitization inventory (CSI)
timeFrame: four weeks after the ending of sessions
Other outcomes:
Locations:
city: Ismailia
country: Egypt
facility: Suez Canal University Hospital
Study officials:
affiliation: Suez Canal University
name: Mona S Ghaly, MD
role: STUDY_DIRECTOR
References: