Assessment of the Effects of Extensive Somatosensory Training on Pain Processing

Sponsor

Aalborg University (Other)

Overall Status

Terminated

CT.gov ID

NCT04457466

Collaborator

University of Aarhus (Other), Lundbeck Foundation (Other), Danish National Research Foundation (Other)

100

Enrollment

Location

Actual Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Musculoskeletal Pain	Drug: Nerve Growth Factor

Study Design

Study Type:

Observational

Actual Enrollment :

100 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Assessment of the Effects of Extensive Sensorimotor Training on Pain Processing

Actual Study Start Date :

Oct 1, 2017

Actual Primary Completion Date :

Oct 1, 2018

Actual Study Completion Date :

Jul 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Healthy musicians Men and women aged 18-60, who must be enrolled in a music conservatory performance program or be professionally active, and must speak and understand English.	Drug: Nerve Growth Factor Induction of experimental muscle soreness using intramuscular injections of Nerve Growth Factor.
Healthy non-musicians Men and women aged 18-60, must speak and understand English and not have any kind of musical training.	Drug: Nerve Growth Factor Induction of experimental muscle soreness using intramuscular injections of Nerve Growth Factor.
Musicians with chronic pain Men and women aged 18-60 with chronic and idiopathic musculoskeletal upper limb and/or neck pain lasting more than 6 months. They must be enrolled in a music conservatory performance program or be professionally active and must speak and understand English.	Drug: Nerve Growth Factor Induction of experimental muscle soreness using intramuscular injections of Nerve Growth Factor.
Non-musicians with chronic pain Men and women aged 18-60 with chronic and idiopathic musculoskeletal upper limb and/or neck pain lasting more than 6 months. They must not have any kind of musical training and must speak and understand English.	Drug: Nerve Growth Factor Induction of experimental muscle soreness using intramuscular injections of Nerve Growth Factor.

Outcome Measures

Primary Outcome Measures

Pain rating [Changes from baseline measured at day 3 and day 8]
Pain on an 11-point numerical rating scale (0 = no pain, 10 = most intense pain imaginable)
Cortical Sensory Evoked Potentials [Changes from baseline measured at day 3 and day 8]
Electrical stimulation will be elicited to record sensory evoked potentials using electroencephalography (EEG)
Motor Evoked Potentials [Changes from baseline measured at day 3 and day 8]
Transcranial magnetic stimualtion will be used to evoke motor evoked potentials (MEPs)
Brain connectivity [Changes from baseline measured at day 3 and day 8]
Continuous electroencephalography recording will be used to explore connectivity between brain areas

Secondary Outcome Measures

Questionnaires [Changes from baseline measured at day 3 and day 8]
Questionnaires about pain and muscle soreness (Pain catastrophization; State and Trait anxiety; Pain vigilance)
Pressure pain thresholds [Changes from baseline measured at day 3 and day 8]
Pressure applied to the surface of the skin using a handheld algometer

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Aalborg University	Aalborg	Nordjylland	Denmark	9000

Sponsors and Collaborators

Aalborg University
University of Aarhus
Lundbeck Foundation
Danish National Research Foundation

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Anna M. Zamorano, Principal Investigator, Aalborg University

ClinicalTrials.gov Identifier:

NCT04457466

Other Study ID Numbers:

10042017

First Posted:

Jul 7, 2020

Last Update Posted:

Mar 3, 2022

Last Verified:

Feb 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Musculoskeletal Pain

Mitogens

Study Results

No Results Posted as of Mar 3, 2022