rTMS on Diabetic Peripheral Neuropathic Pain

Diabetic Peripheral Neuropathic Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04833660
• Other study ID #: YUMC 2021-03-043
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 30, 2021
• Est. completion date: June 15, 2021

Study information

• Verified date: April 2021
• Source: Yeungnam University College of Medicine
• Contact: Chang
• Phone: +82-10-9362-1220
• Email: wheel633[@]ynu.ac.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 22
• Est. completion date: June 15, 2021
• Est. primary completion date: May 25, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 80 Years

Eligibility

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

Exclusion Criteria:

• presence of contraindications for TMS, such as a history of epileptic seizure, presence of metal in the skull, and presence of a cardiac pacemaker.

Related Conditions & MeSH terms

• Diabetic Neuropathies
• Diabetic Peripheral Neuropathic Pain
• Neuralgia

Intervention

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).

Locations

Country	Name	City	State
Korea, Republic of	Yeungnam University Hospital	Daegu

Sponsors (1)

Lead Sponsor	Collaborator
Min Cheol Chang

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (32)

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* Note: There are 32 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain before intervention to be assessed with Numeric Rating Scale	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).	The NRS score will be assessed the day before starting the stimulation sessions (pre-treatment).
Primary	Pain after intervention to be assessed with Numeric Rating Scale	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).	The NRS score will be assessed 1 day after the completion of the sessions.
Primary	Pain after intervention to be assessed with Numeric Rating Scale	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).	The NRS score will be assessed 1 week after the completion of the sessions.
Primary	Quality of life before intervention to be assessed with Short Form 36-Item Health Survey	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.	The SF-36 PCS and SF-36 MCS will be measured the day before starting the stimulation sessions.
Primary	Quality of life after intervention to be assessed with Short Form 36-Item Health Survey	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.	The SF-36 PCS and SF-36 MCS will be measured 1 week after the completion of the sessions.