Cortical Neuroplasticity by Muscle Pain of Pain-induced Plasticity

Not Applicable

Completed

• Conditions: Nerve Growth Factor; Exercise; Motor Activity; Abnormality of SSEPs; Hyperalgesia
• Interventions: Drug: Sterile solutions of recombinant human nerve growth factor (NGF)

• Registration Number: NCT03354624
• Lead Sponsor: Aalborg University

Brief 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).

Detailed 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);

Study Timeline

• Study First Submitted: 2017-11-19
• Study Start: 2017-11-26
• Study First Submitted QC: 2017-11-26
• Study First Posted: 2017-11-28
• Primary Completion: 2018-02-28
• 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: 24

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
Nerve growth factor group	Sterile solutions of recombinant human nerve growth factor (NGF)	Three injections of sterile solutions of recombinant human nerve growth factor (NGF) will be performed in the right extensor carpi radialis muscle to induce muscle hyperalgesia.
Nerve growth factor group + delayed onset muscle soreness	Sterile solutions of recombinant human nerve growth factor (NGF)	Injections of nerve growth factor and eccentric exercise of the extensor carpi radialis muscle will be performed to induce muscle hyperalgesia.

Primary Outcome Measures

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

Trial Locations

Locations (1)

Aalborg University; 🇩🇰 Aalborg, Nordjylland, Denmark