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Cortical Neuroplasticity by Muscle Pain of Pain-induced Plasticity

Primary Purpose

Nerve Growth Factor, Exercise, Motor Activity

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Sterile solutions of recombinant human nerve growth factor (NGF)
Sponsored by
Aalborg University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Nerve Growth Factor

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • Aalborg University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Nerve growth factor group

Nerve growth factor group + delayed onset muscle soreness

Arm Description

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.

Injections of nerve growth factor and eccentric exercise of the extensor carpi radialis muscle will be performed to induce muscle hyperalgesia.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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'
Patient-rated Tennis Elbow Evaluation
The Patient-rated Tennis Elbow Evaluation will be used to assess average pain and disability of the injected arm
Pressure pain thresholds
Pressure applied to the surface of the skin using a handheld algometer.
Motor evoked potentials
Transcranial magnetic stimualtion will be used to evoke motor evoked potentials (MEPs) to the extensor carpi radialis muscle
Sensory evoked potentials
EEG recodring
Alpha oscillations
Continuous EEG recording

Full Information

First Posted
November 19, 2017
Last Updated
March 2, 2018
Sponsor
Aalborg University
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1. Study Identification

Unique Protocol Identification Number
NCT03354624
Brief Title
Cortical Neuroplasticity by Muscle Pain of Pain-induced Plasticity
Official Title
Cortical Neuroplasticity by Muscle Pain and Non-invasive Modulation of Pain-induced Plasticity
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
November 26, 2017 (Actual)
Primary Completion Date
February 28, 2018 (Actual)
Study Completion Date
February 28, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aalborg University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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);

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nerve Growth Factor, Exercise, Motor Activity, Abnormality of SSEPs, Hyperalgesia

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Nerve growth factor group
Arm Type
Experimental
Arm Description
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.
Arm Title
Nerve growth factor group + delayed onset muscle soreness
Arm Type
Experimental
Arm Description
Injections of nerve growth factor and eccentric exercise of the extensor carpi radialis muscle will be performed to induce muscle hyperalgesia.
Intervention Type
Drug
Intervention Name(s)
Sterile solutions of recombinant human nerve growth factor (NGF)
Intervention Description
The intramuscular injections of NGF cause muscle soreness.
Primary Outcome Measure Information:
Title
Pain rating
Description
Pain on an 11-point numerical rating scale (0 = no pain, 10 = most intense pain imaginable)
Time Frame
Change from baseline at 2 weeks
Secondary Outcome Measure Information:
Title
Muscle soreness
Description
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'
Time Frame
Change from baseline at 2 weeks
Title
Patient-rated Tennis Elbow Evaluation
Description
The Patient-rated Tennis Elbow Evaluation will be used to assess average pain and disability of the injected arm
Time Frame
Change from baseline at 2 weeks
Title
Pressure pain thresholds
Description
Pressure applied to the surface of the skin using a handheld algometer.
Time Frame
Change from baseline at 2 weeks
Title
Motor evoked potentials
Description
Transcranial magnetic stimualtion will be used to evoke motor evoked potentials (MEPs) to the extensor carpi radialis muscle
Time Frame
Change from baseline at 1 week
Title
Sensory evoked potentials
Description
EEG recodring
Time Frame
Change from baseline at 1 week
Title
Alpha oscillations
Description
Continuous EEG recording
Time Frame
Change from baseline at 1 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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)
Facility Information:
Facility Name
Aalborg University
City
Aalborg
State/Province
Nordjylland
ZIP/Postal Code
9000
Country
Denmark

12. IPD Sharing Statement

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Cortical Neuroplasticity by Muscle Pain of Pain-induced Plasticity

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