Cortical Neuroplasticity by Muscle Pain of Pain-induced Plasticity

Exercise Clinical Trial

Official title:

Cortical Neuroplasticity by Muscle Pain and Non-invasive Modulation of Pain-induced Plasticity

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03354624
• Other study ID #: N-20160022
• Status: Completed
• Phase: N/A
• First received: November 19, 2017
• Last updated: March 2, 2018
• Start date: November 26, 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 purpose of this study is to investigate the sensory-motor cortical excitability response to delayed onset muscle soreness (DOMS) on Extensor Carpi Radialis (ECR) muscle during muscle hyperalgesia provoked by nerve growth factor (NGF).

Description:

The purpose of this study is to assess changes in sensory-motor cortical excitability during experimental muscle hyperalgesia across several days provoked by injections of nerve growth factor (NGF) into the Extensor Carpi Radialis (ECR) muscle and delayed onset muscle soreness (DOMS) of the ECR muscle.

It was hypothesized that muscle hyperalgesia across several days would result in:

i) Increased sensory cortical excitability, based on somatosensory evoked potentials by means of electrical stimulation of the radial nerve, (increase of central-parietal evoked-potential P45 and decrease of frontal evoked-potential N30); ii) Increased corticomotor excitability of a ECR (increase map volume and number of active sites), assessed as motor evoked potentials induced by transcranial magnetic stimulation in primary motor cortex (M1); iii) Reduction of alpha oscillation based on nociceptive stimulus-evoked suppression of alpha activity in sensory regions (recording electrodes on contra-lateral parietal area);

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: February 28, 2018
• Est. primary completion date: February 28, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 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

• Abnormality of SSEPs
• Exercise
• Hyperalgesia
• Motor Activity
• Myalgia
• Nerve Growth Factor

Intervention

Drug:
• Sterile solutions of recombinant human nerve growth factor (NGF)
The intramuscular injections of NGF cause muscle soreness.

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 rating	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	Pressure pain thresholds	Pressure applied to the surface of the skin using a handheld algometer.	Change from baseline at 2 weeks
Secondary	Motor evoked potentials	Transcranial magnetic stimualtion will be used to evoke motor evoked potentials (MEPs) to the extensor carpi radialis muscle	Change from baseline at 1 week
Secondary	Sensory evoked potentials	EEG recodring	Change from baseline at 1 week
Secondary	Alpha oscillations	Continuous EEG recording	Change from baseline at 1 weeks