Repetitive Transcranial Magnetic Stimulation and the Development of Ongoing Muscle Pain

Not Applicable

Completed

• Conditions: Pain Relief
• Interventions: Device: Repetitive trancranial magnetic stimulation (rTMS) group; Device: Sham group

• Registration Number: NCT03263884
• Lead Sponsor: Aalborg University

Brief 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.

Detailed 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).

Study Timeline

• Study Start: 2017-08-01
• Study First Submitted: 2017-08-24
• Study First Submitted QC: 2017-08-25
• Study First Posted: 2017-08-28
• Primary Completion: 2017-11-30
• Study Completion: 2018-02-28
• Status Verified: 2018-03
• Last Update Submitted: 2018-03-02
• Last Update Posted: 2018-03-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Real treatment group	Repetitive trancranial magnetic stimulation (rTMS) group	Transcranial magnetic stimulation (TMS) is used to stimulate small regions of the brain. During a TMS procedure, a magnetic field generator, or "coil", is placed near the head of the person receiving the treatment. The coil produces small electric currents in the region of the brain just under the coil via electromagnetic induction. The protocol used in this research includes 20 minutes of 10Hz stimulation, 5 seconds on, 10 seconds off, at 110% RMT, for a total of 4000 pulses.
Sham treatment group	Sham group	Sham coil is used to mimic the clicking sound of the TMS coil and skin stimulation

Primary Outcome Measures

Name	Time	Method
Pain relief	Change from baseline at 2 weeks	Pain on an 11-point numerical rating scale (0 = no pain, 10 = most intense pain imaginable)

Secondary Outcome Measures

Name	Time	Method
Muscle soreness	Change from baseline at 2 weeks	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'
Patient-rated Tennis Elbow Evaluation	Change from baseline at 2 weeks	The Patient-rated Tennis Elbow Evaluation will be used to assess average pain and disability of the injected arm
Attention network test	Change from baseline at 2 weeks	This task assesses cognitive function in 3 domains: alerting, orienting, and executive function
Pressure pain thresholds	Change from baseline at 2 weeks	Pressure applied to the surface of the skin using a handheld algometer.
Cuff pressure algometry	Change from baseline at 2 weeks	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.
EEG recordings	Change from baseline at 1 weeks	we will record brain activity in the following conditions: eyes closed rest, performance of a computer-based cognitive task (ANT).

Trial Locations

Locations (1)

Aalborg University; 🇩🇰 Aalborg, Nordjylland, Denmark