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Clinical Trials/NCT03354624
NCT03354624
Completed
N/A

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

Aalborg University1 site in 1 country24 target enrollmentNovember 26, 2017

Overview

Phase
N/A
Intervention
Sterile solutions of recombinant human nerve growth factor (NGF)
Conditions
Nerve Growth Factor
Sponsor
Aalborg University
Enrollment
24
Locations
1
Primary Endpoint
Pain rating
Status
Completed
Last Updated
8 years ago

Overview

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);

Registry
clinicaltrials.gov
Start Date
November 26, 2017
End Date
February 28, 2018
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Aalborg University
Responsible Party
Principal Investigator
Principal Investigator

Enrico De Martino

Medical Doctor

Aalborg University

Eligibility Criteria

Inclusion Criteria

  • Healthy men and women
  • Speak and understand English.

Exclusion Criteria

  • 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)

Arms & Interventions

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.

Intervention: Sterile solutions of recombinant human nerve growth factor (NGF)

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.

Intervention: Sterile solutions of recombinant human nerve growth factor (NGF)

Outcomes

Primary Outcomes

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 Outcomes

  • Muscle soreness(Change from baseline at 2 weeks)
  • Pressure pain thresholds(Change from baseline at 2 weeks)
  • Motor evoked potentials(Change from baseline at 1 week)
  • Sensory evoked potentials(Change from baseline at 1 week)
  • Alpha oscillations(Change from baseline at 1 weeks)
  • Patient-rated Tennis Elbow Evaluation(Change from baseline at 2 weeks)

Study Sites (1)

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