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

NCT03795961 | Unknown DMC FDA Device

• 1 other identifier: GSMGAEAM
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

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.

Conditions

Carpal Tunnel Syndrome

Outcome Measures

Primary Outcomes (9)

• Visual analogue scale

  Visual analogue scale is a measurement instrument that measure the pain across a continuum of values. Visual analogue scale is measured in millimeters and ranged from minimum (0 millimeter) to maximum (100 millimeters), where, score 0 indicates no pain and 100 indicates worst pain ever.

  before sessions (baseline assessment)

• Visual analogue scale (VAS)

  Visual analogue scale is a measurement instrument that measure the pain across a continuum of values. Visual analogue scale is measured in millimeters and ranged from minimum (0 millimeter) to maximum (100 millimeters), where, score 0 indicates no pain and 100 indicates worst pain ever.

  immediately after the ending of sessions

• Visual analogue scale (VAS)

  Visual analogue scale is a measurement instrument that measure the pain across a continuum of values. Visual analogue scale is measured in millimeters and ranged from minimum (0 millimeter) to maximum (100 millimeters), where, score 0 indicates no pain and 100 indicates worst pain ever.

  four weeks after the ending of sessions

• Sensory threshold and pain threshold for electrical stimulation

  Electrical stimulation will be applied by a pen electrode (model: 2762CC; Chattanooga) to the median nerve (pulse duration - 200 microseconds) at wrist level. Current supply start at 0 milli-ampere and will be increased in steps of 0.1 milli-ampere, until the participant report sensation and pain. The intensity of current (in milli-ampere) at which perception of the electrical stimulus first reported will be taken as sensory threshold; the intensity of current (in milli-ampere) at which participants first reported pain will be taken as pain threshold. These measurements will be averaged for analysis. Both sides will be assessed and compared. The lower the intensity of current (in milli-ampere) perceived, the worse the threshold, while the higher the intensity of current (in milli-ampere) perceived, the better the threshold.

  before sessions (baseline assessment)

• Sensory threshold and pain threshold for electrical stimulation

  Electrical stimulation will be applied by a pen electrode (model: 2762CC; Chattanooga) to the median nerve (pulse duration - 200 microseconds) at wrist level. Current supply start at 0 milli-ampere and will be increased in steps of 0.1 milli-ampere, until the participant report sensation and pain. The intensity of current (in milli-ampere) at which perception of the electrical stimulus first reported will be taken as sensory threshold; the intensity of current (in milli-ampere) at which participants first reported pain will be taken as pain threshold. These measurements will be averaged for analysis. Both sides will be assessed and compared. The lower the intensity of current (in milli-ampere) perceived, the worse the threshold, while the higher the intensity of current (in milli-ampere) perceived, the better the threshold.

  immediately after the ending of sessions

• Sensory threshold and pain threshold for electrical stimulation

  Electrical stimulation will be applied by a pen electrode (model: 2762CC; Chattanooga) to the median nerve (pulse duration - 200 microseconds) at wrist level. Current supply start at 0 milli-ampere and will be increased in steps of 0.1 milli-ampere, until the participant report sensation and pain. The intensity of current (in milli-ampere) at which perception of the electrical stimulus first reported will be taken as sensory threshold; the intensity of current (in milli-ampere) at which participants first reported pain will be taken as pain threshold. These measurements will be averaged for analysis. Both sides will be assessed and compared. The lower the intensity of current (in milli-ampere) perceived, the worse the threshold, while the higher the intensity of current (in milli-ampere) perceived, the better the threshold.

  four weeks after the ending of sessions

• Pressure pain threshold assessment

  Pressure will be induced using a pressure algometer (PainTest™ FPN 100 Algometer (Wagner Instruments, Greenwich, USA)) with a flat circular metal probe dressed in a rubber cover with a surface area of 1 cm2 applied to median, ulnar, radial, and c5-6 zygoapophyseal joint, The algometer will be mounted vertically and the pressure will be increased. Patients are asked to notify the investigator when they start to feel pain (pain threshold). For each measurement the algometer will be calibrated to enable force to be applied at a controlled and steady rate, the mean of three trials (intra-examiner reliability) will be calculated and used for main analysis. A 30 seconds resting period will be allowed between each measure. Both sides will be assessed and compared. Abnormal pressure pain threshold is at least 2 kg/cm2 different than that of the opposite site. The lower the value perceived, the worse the threshold, while the higher the value perceived, the better the threshold.

  before sessions (baseline assessment)

• Pressure pain threshold assessment

  Pressure will be induced using a pressure algometer (PainTest™ FPN 100 Algometer (Wagner Instruments, Greenwich, USA)) with a flat circular metal probe dressed in a rubber cover with a surface area of 1 cm2 applied to median, ulnar, radial, and c5-6 zygoapophyseal joint, The algometer will be mounted vertically and the pressure will be increased. Patients are asked to notify the investigator when they start to feel pain (pain threshold). For each measurement the algometer will be calibrated to enable force to be applied at a controlled and steady rate, the mean of three trials (intra-examiner reliability) will be calculated and used for main analysis. A 30 seconds resting period will be allowed between each measure. Both sides will be assessed and compared. Abnormal pressure pain threshold is at least 2 kg/cm2 different than that of the opposite site. The lower the value perceived, the worse the threshold, while the higher the value perceived, the better the threshold.

  immediately after the ending of sessions

• Pressure pain threshold assessment

  Pressure will be induced using a pressure algometer (PainTest™ FPN 100 Algometer (Wagner Instruments, Greenwich, USA)) with a flat circular metal probe dressed in a rubber cover with a surface area of 1 cm2 applied to median, ulnar, radial, and c5-6 zygoapophyseal joint, The algometer will be mounted vertically and the pressure will be increased. Patients are asked to notify the investigator when they start to feel pain (pain threshold). For each measurement the algometer will be calibrated to enable force to be applied at a controlled and steady rate, the mean of three trials (intra-examiner reliability) will be calculated and used for main analysis. A 30 seconds resting period will be allowed between each measure. Both sides will be assessed and compared. Abnormal pressure pain threshold is at least 2 kg/cm2 different than that of the opposite site. The lower the value perceived, the worse the threshold, while the higher the value perceived, the better the threshold.

  four weeks after the ending of sessions

Secondary Outcomes (6)

• Boston carpal tunnel syndrome questionnaire

  before sessions (baseline assessment)

• Boston carpal tunnel syndrome questionnaire

  immediately after the ending of sessions

• Boston carpal tunnel syndrome questionnaire

  four weeks after the ending of sessions

• Central sensitization inventory

  before sessions (baseline assessment)

• Central sensitization inventory (CSI)

  immediately after the ending of sessions

Study Arms (2)

Active tDCS group

EXPERIMENTAL

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)

Device: transcranial direct current electrical stimulation

Sham tDCS group

SHAM COMPARATOR

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)

Device: transcranial direct current electrical stimulation

Interventions

transcranial direct current electrical stimulation DEVICE

anodal tDCS of M1 for 20 minutes, at 2 mA for 5 sessions (day after day)

Active tDCS group; Sham tDCS group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Suez Canal University: lead

Study Sites (1)

Suez Canal University Hospital

Ismailia, 41522, Egypt

RECRUITING

MeSH Terms

Conditions

Carpal Tunnel Syndrome

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Median Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Officials

• Mona S Ghaly, MD

  Suez Canal University

  STUDY DIRECTOR

Central Study Contacts

Gehad Swilam

CONTACT

+201027089991; gsa237@gmail.com

Ahmed Maaty

CONTACT

+201027089991; aimaaty@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer

Model Details: the study subject will be allocated into two group ; active and sham group

Study Record Dates

• First Submitted: January 3, 2019
• First Posted: January 8, 2019
• Study Start: December 16, 2018
• Primary Completion: January 1, 2020
• Study Completion: March 1, 2020
• Last Updated: January 8, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)