Assessment of the Effects of Extensive Somatosensory Training on Pain Processing

Musculoskeletal Pain Clinical Trial

Official title:

Assessment of the Effects of Extensive Sensorimotor Training on Pain Processing

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04457466
• Other study ID #: 10042017
• Status: Terminated
• Start date: October 1, 2017
• Est. completion date: July 1, 2020

Study information

• Verified date: February 2022
• Source: Aalborg University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Persistent pain may lead to several alterations in the brain activity and sensory perception (i.e. pain). Around 80% of professional musicians experience prolonged episodes of musculoskeletal pain throughout their careers, a percentage that is four times higher than in the general population. With this background, the intended experiment aims at understanding the role of several biological factors associated to sensorimotor training that can lead to alteration of the brain activity and, consequently, pain processing.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 100
• Est. completion date: July 1, 2020
• Est. primary completion date: October 1, 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.

General exclusion criteria are:

• Pregnancy
• Drug addiction defined as the use of cannabis, opioids or other drugs
• Previous neurologic or mental illnesses
• Presence of a history of trauma or neurologic entrapment syndromes to the arm regions.
• Lack of ability to cooperate
• Frequent computer gamer ( > 9 hours/week)

Related Conditions & MeSH terms

• Musculoskeletal Pain

Intervention

Drug:
• Nerve Growth Factor
Induction of experimental muscle soreness using intramuscular injections of Nerve Growth Factor.

Locations

Country	Name	City	State
Denmark	Aalborg University	Aalborg	Nordjylland

Sponsors (4)

Lead Sponsor	Collaborator
Aalborg University	Danish National Research Foundation, Lundbeck Foundation, University of Aarhus

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)	Changes from baseline measured at day 3 and day 8
Primary	Cortical Sensory Evoked Potentials	Electrical stimulation will be elicited to record sensory evoked potentials using electroencephalography (EEG)	Changes from baseline measured at day 3 and day 8
Primary	Motor Evoked Potentials	Transcranial magnetic stimualtion will be used to evoke motor evoked potentials (MEPs)	Changes from baseline measured at day 3 and day 8
Primary	Brain connectivity	Continuous electroencephalography recording will be used to explore connectivity between brain areas	Changes from baseline measured at day 3 and day 8
Secondary	Questionnaires	Questionnaires about pain and muscle soreness (Pain catastrophization; State and Trait anxiety; Pain vigilance)	Changes from baseline measured at day 3 and day 8
Secondary	Pressure pain thresholds	Pressure applied to the surface of the skin using a handheld algometer	Changes from baseline measured at day 3 and day 8