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Cortical Neuroplasticity by Muscle Pain of Pain-induced Plasticity

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ClinicalTrials.gov Identifier: NCT03354624
Recruitment Status : Completed
First Posted : November 28, 2017
Last Update Posted : March 5, 2018
Sponsor:
Information provided by (Responsible Party):
Enrico De Martino, 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).

Condition or disease Intervention/treatment Phase
Nerve Growth Factor Exercise Motor Activity Abnormality of SSEPs Hyperalgesia Drug: Sterile solutions of recombinant human nerve growth factor (NGF) Not Applicable

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);


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Official Title: Cortical Neuroplasticity by Muscle Pain and Non-invasive Modulation of Pain-induced Plasticity
Actual Study Start Date : November 26, 2017
Actual Primary Completion Date : February 28, 2018
Actual Study Completion Date : February 28, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Nerve growth factor group
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.
Drug: Sterile solutions of recombinant human nerve growth factor (NGF)
The intramuscular injections of NGF cause muscle soreness.

Experimental: Nerve growth factor group + delayed onset muscle soreness
Injections of nerve growth factor and eccentric exercise of the extensor carpi radialis muscle will be performed to induce muscle hyperalgesia.
Drug: Sterile solutions of recombinant human nerve growth factor (NGF)
The intramuscular injections of NGF cause muscle soreness.




Primary Outcome Measures :
  1. Pain rating [ 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 Outcome Measures :
  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. Pressure pain thresholds [ Time Frame: Change from baseline at 2 weeks ]
    Pressure applied to the surface of the skin using a handheld algometer.

  4. Motor evoked potentials [ Time Frame: Change from baseline at 1 week ]
    Transcranial magnetic stimualtion will be used to evoke motor evoked potentials (MEPs) to the extensor carpi radialis muscle

  5. Sensory evoked potentials [ Time Frame: Change from baseline at 1 week ]
    EEG recodring

  6. Alpha oscillations [ Time Frame: Change from baseline at 1 weeks ]
    Continuous EEG recording



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03354624


Locations
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Denmark
Aalborg University
Aalborg, Nordjylland, Denmark, 9000
Sponsors and Collaborators
Aalborg University

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Responsible Party: Enrico De Martino, Medical Doctor, Aalborg University
ClinicalTrials.gov Identifier: NCT03354624     History of Changes
Other Study ID Numbers: N-20160022
First Posted: November 28, 2017    Key Record Dates
Last Update Posted: March 5, 2018
Last Verified: March 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Myalgia
Hyperalgesia
Somatosensory Disorders
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Diseases
Musculoskeletal Pain
Pain
Mitogens
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action