Skip to main content
OpenTrials
Completed

NCT Number: NCT03263884

Repetitive Transcranial Magnetic Stimulation and the Development of Ongoing Muscle Pain

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Pain Relief Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Hereditary Sensory and Autonomic Neuropathies Heredodegenerative Disorders, Nervous System Nervous System Diseases Nervous System Malformations Neurodegenerative Diseases Neuromuscular Diseases Peripheral Nervous System Diseases Polyneuropathies

Age range

21 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Aalborg University

Aalborg, North Denmark, 9000, Denmark

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Repetitive trancranial magnetic stimulation (rTMS) group

Device

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

Device

A sham coil is used to mimic the clicking sound of the trancranial magnetic coil and skin stimulation.

Primary outcomes

  1. Pain relief

    Time frame: Change from baseline at 2 weeks

    Pain on an 11-point numerical rating scale (0 = no pain, 10 = most intense pain imaginable)

Secondary outcomes

  1. Muscle soreness

    Time frame: 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'

  2. Patient-rated Tennis Elbow Evaluation

    Time frame: 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

  3. Attention network test

    Time frame: Change from baseline at 2 weeks

    This task assesses cognitive function in 3 domains: alerting, orienting, and executive function

  4. Pressure pain thresholds

    Time frame: Change from baseline at 2 weeks

    Pressure applied to the surface of the skin using a handheld algometer.

  5. Cuff pressure algometry

    Time frame: 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.

  6. EEG recordings

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Aalborg University

Other

Registry information

Important dates

Study start
2017
Primary completion
2017
Study completion
2018
First posted
Aug 28, 2017
Registry last updated
Mar 5, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.