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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03354624
Other study ID # N-20160022
Secondary ID
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
Health authority
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)

Study Design


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
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