rTMS on Diabetic Peripheral Neuropathic Pain

Sponsor

Min Cheol Chang (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT04833660

Collaborator

(none)

Enrollment

Location

Arms

1.5

Anticipated Duration (Months)

14.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Background: Approximately half of the patients with long-standing diabetes are known to have diabetic peripheral neuropathy (DPN). Pain from DPN deteriorates the quality of life and hinders daily life activities.

Objectives: This study aimed to evaluate the effect of high-frequency (10 Hz) repetitive transcranial magnetic stimulation (rTMS) on the left primary motor cortex (M1) for neuropathic pain in the lower extremities due to DPN.

Methods: In this randomized trial, 22 patients with DPN will randomly assign to the rTMS group (10 Hz stimulation, five sessions) or the sham group. A numeric rating scale (NRS) will use to measure pain intensity before treatment and after 1 day and 1 week of the treatment. Physical and mental health status will evaluate using the Short Form 36-Item Health Survey (SF-36), comprising two subscales (physical and mental component scores [PCSs and MCSs]), at 1-week post-treatment.

Condition or Disease	Intervention/Treatment	Phase
Diabetic Peripheral Neuropathic Pain	Device: repetitive transcranial magnetic stimulation	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

22 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

The Effect of Repetitive Transcranial Magnetic Stimulation on Diabetic Peripheral Neuropathic Pain: A Randomized Controlled Trial

Anticipated Study Start Date :

Apr 30, 2021

Anticipated Primary Completion Date :

May 25, 2021

Anticipated Study Completion Date :

Jun 15, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: rTMS group Each patient will receive five consecutive sessions (Monday to Friday for 1 week). Patients in the rTMS group will administer rTMS over the optimal scalp site at 10 Hz, with an intensity of 90% of the MT and a duration of 5 seconds, for a total of 20 trains separated by 55-second intertrain pauses (a total of 1,000 pulses). The coil will be placed tangentially to the scalp at an approximate angle of 45° tilted backward and laterally. Oral medication dosages of all patients will unchanged during the stimulation and follow-up periods.	Device: repetitive transcranial magnetic stimulation Repetitive transcranial magnetic stimulation (rTMS) is a safe, noninvasive, and effective therapeutic intervention that uses an electromagnetic coil applied to the scalp to produce a magnetic field. rTMS induces changes in cortical excitability at the stimulation site and transsynaptically at distant areas. Cortical excitability is increased by high-frequency (≥5 Hz) stimulation and is decreased by low-frequency (1 Hz) stimulation. The application of high-frequency unilateral rTMS to the motor cortex in patients is reported to have a potential to control various types of pain, such as neuropathic pain, fibromyalgia, and musculoskeletal origin pain (myofascial pain syndrome, shoulder pain, and lower back pain).
Sham Comparator: sham group Patients in the sham group will administer sham stimulation using the same protocol, except that the angle of the coil is 90° (i.e., perpendicular, rather than tangential) to the skull. Oral medication dosages of all patients will unchanged during the stimulation and follow-up periods.	Device: repetitive transcranial magnetic stimulation Repetitive transcranial magnetic stimulation (rTMS) is a safe, noninvasive, and effective therapeutic intervention that uses an electromagnetic coil applied to the scalp to produce a magnetic field. rTMS induces changes in cortical excitability at the stimulation site and transsynaptically at distant areas. Cortical excitability is increased by high-frequency (≥5 Hz) stimulation and is decreased by low-frequency (1 Hz) stimulation. The application of high-frequency unilateral rTMS to the motor cortex in patients is reported to have a potential to control various types of pain, such as neuropathic pain, fibromyalgia, and musculoskeletal origin pain (myofascial pain syndrome, shoulder pain, and lower back pain).

Arm

Intervention/Treatment

Experimental: rTMS group

Each patient will receive five consecutive sessions (Monday to Friday for 1 week). Patients in the rTMS group will administer rTMS over the optimal scalp site at 10 Hz, with an intensity of 90% of the MT and a duration of 5 seconds, for a total of 20 trains separated by 55-second intertrain pauses (a total of 1,000 pulses). The coil will be placed tangentially to the scalp at an approximate angle of 45° tilted backward and laterally. Oral medication dosages of all patients will unchanged during the stimulation and follow-up periods.

Device: repetitive transcranial magnetic stimulation

Repetitive transcranial magnetic stimulation (rTMS) is a safe, noninvasive, and effective therapeutic intervention that uses an electromagnetic coil applied to the scalp to produce a magnetic field. rTMS induces changes in cortical excitability at the stimulation site and transsynaptically at distant areas. Cortical excitability is increased by high-frequency (≥5 Hz) stimulation and is decreased by low-frequency (1 Hz) stimulation. The application of high-frequency unilateral rTMS to the motor cortex in patients is reported to have a potential to control various types of pain, such as neuropathic pain, fibromyalgia, and musculoskeletal origin pain (myofascial pain syndrome, shoulder pain, and lower back pain).

Sham Comparator: sham group

Patients in the sham group will administer sham stimulation using the same protocol, except that the angle of the coil is 90° (i.e., perpendicular, rather than tangential) to the skull. Oral medication dosages of all patients will unchanged during the stimulation and follow-up periods.

Device: repetitive transcranial magnetic stimulation

Outcome Measures

Primary Outcome Measures

Pain before intervention to be assessed with Numeric Rating Scale [The NRS score will be assessed the day before starting the stimulation sessions (pre-treatment).]
We will be assessed pain intensity using the NRS score as the primary outcome. Average pain intensity during the 24 hours before NRS assessment will be investigated. The Numeric Rating Scale (NRS) is the simplest and most commonly used numeric scale in which people rate the pain from 0 (no pain) to 10 (worst pain).
Pain after intervention to be assessed with Numeric Rating Scale [The NRS score will be assessed 1 day after the completion of the sessions.]
We will be assessed pain intensity using the NRS score as the primary outcome. Average pain intensity during the 24 hours before NRS assessment will be investigated. The Numeric Rating Scale (NRS) is the simplest and most commonly used numeric scale in which people rate the pain from 0 (no pain) to 10 (worst pain).
Pain after intervention to be assessed with Numeric Rating Scale [The NRS score will be assessed 1 week after the completion of the sessions.]
We will be assessed pain intensity using the NRS score as the primary outcome. Average pain intensity during the 24 hours before NRS assessment will be investigated. The Numeric Rating Scale (NRS) is the simplest and most commonly used numeric scale in which people rate the pain from 0 (no pain) to 10 (worst pain).
Quality of life before intervention to be assessed with Short Form 36-Item Health Survey [The SF-36 PCS and SF-36 MCS will be measured the day before starting the stimulation sessions.]
We will be measured health-related quality of life using the Short Form 36-Item Health Survey (SF-36). The SF-36 has two subscales: physical component score (PCS) and mental component score (MCS), reflecting overall physical and mental health status, respectively. The SF-36 consists of eight components: physical functioning, physical role functioning, bodily pain, general health perceptions, vitality, social role functioning, emotional role functioning, and mental health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.
Quality of life after intervention to be assessed with Short Form 36-Item Health Survey [The SF-36 PCS and SF-36 MCS will be measured 1 week after the completion of the sessions.]
We will be measured health-related quality of life using the Short Form 36-Item Health Survey (SF-36). The SF-36 has two subscales: physical component score (PCS) and mental component score (MCS), reflecting overall physical and mental health status, respectively. The SF-36 consists of eight components: physical functioning, physical role functioning, bodily pain, general health perceptions, vitality, social role functioning, emotional role functioning, and mental health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

diabetes
neuropathic pain (stocking glove distribution) of a numeric rating scale (NRS) score of ≥3 (where 0 indicates no pain and 10 indicates the most intense pain imaginable) in the lower extremities
pain duration of ≥3 months
age between 21 and 80 years