Repetitive Transcranial Magnetic Stimulation and the Development of Ongoing Muscle Pain

Pain Relief Clinical Trial

Official title:

Repetitive Transcranial Magnetic Stimulation and the Development of Ongoing Muscle Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03263884
• Other study ID #: N-20170041
• Status: Completed
• Phase: N/A
• First received: August 24, 2017
• Last updated: March 2, 2018
• Start date: August 1, 2017
• Est. completion date: February 28, 2018

Study information

• Verified date: March 2018
• Source: Aalborg University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The main purpose of the study is to assess the mechanisms of repeated sessions of repetitive trancranial magnetic stimulation (rTMS) applied on left dorsolateral prefrontal cortex on the development of pain in a prolonged muscle pain model.

Description:

This study aims to investigate whether i) rTMS of left DLPFC will reduce the severity and duration of experimentally induced muscle pain when a 5-day course of treatment is given immediately following an initial nerve growth factor (NGF) injection; ii) the analgesic effects of left DLPFC rTMS will be related to an improved cognitive network function as assessed by electroencephalography (EEG).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: February 28, 2018
• Est. primary completion date: November 30, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 50 Years

Eligibility

Inclusion Criteria:

• Healthy men and women

• Speak and understand English.

Exclusion Criteria:

• Pregnancy

• Drug addiction defined as the use of cannabis, opioids or other drugs

• Previous neurologic, musculoskeletal or mental illnesses

• Lack of ability to cooperate

• History of chronic pain or current acute pain

• Previous experience with rTMS

• Contraindications to rTMS application (history of epilepsy, metal in the head or jaw etc.).

• Failure to pass the "TASS questionnaire" (TASS = Transcranial Magnetic Stimulation Adult Safety Screen)

Related Conditions & MeSH terms

• Myalgia
• Pain Relief

Intervention

Device:
• Repetitive trancranial magnetic stimulation (rTMS) group
Repetitive trancranial magnetic stimulation is applied on the dorsolateral prefrontal cortex. The protocol consists on 20 minutes of 10Hz stimulation, 5 seconds on, 10 seconds off, at 110% RMT, for a total of 4000 pulses.
• Sham group
A sham coil is used to mimic the clicking sound of the trancranial magnetic coil and skin stimulation.

Locations

Country	Name	City	State
Denmark	Aalborg University	Aalborg	Nordjylland

Sponsors (1)

Lead Sponsor	Collaborator
Aalborg University

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain relief	Pain on an 11-point numerical rating scale (0 = no pain, 10 = most intense pain imaginable)	Change from baseline at 2 weeks
Secondary	Muscle soreness	7-point Likert scale; 0 = 'a complete absence of soreness', 1 = 'a light soreness in the muscle felt only when touched/vague ache', 2 = 'a moderate soreness felt only when touched/a slight persistent ache', '3 = 'a light muscle soreness when lifting or carrying objects', 4 = 'a light muscle soreness, stiffness or weakness when moving the wrist without gripping an object', 5 = 'a moderate muscle soreness, stiffness or weakness when moving the wrist', 6 = 'a severe muscle soreness, stiffness or weakness that limits the ability to move'	Change from baseline at 2 weeks
Secondary	Patient-rated Tennis Elbow Evaluation	The Patient-rated Tennis Elbow Evaluation will be used to assess average pain and disability of the injected arm	Change from baseline at 2 weeks
Secondary	Attention network test	This task assesses cognitive function in 3 domains: alerting, orienting, and executive function	Change from baseline at 2 weeks
Secondary	Pressure pain thresholds	Pressure applied to the surface of the skin using a handheld algometer.	Change from baseline at 2 weeks
Secondary	Cuff pressure algometry	The experimental setup consists of a tourniquet cuff, a computer-controlled air compressor and an electronic visual analog scale VAS (Aalborg University, Denmark). The cuff is connected to the compressor and wrapped around the leg. The pain intensity is recorded with the electronic VAS and sampled at 10 Hz. The "0 cm" and "10 cm" extremes on the VAS are defined as "no pain" and as "maximal pain", respectively. The compression rate of the cuff is programmed on and controlled by a computer.	Change from baseline at 2 weeks
Secondary	EEG recordings	we will record brain activity in the following conditions: eyes closed rest, performance of a computer-based cognitive task (ANT).	Change from baseline at 1 weeks