NCT04457466

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2017

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2017

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2018

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

June 24, 2020

Completed
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 7, 2020

Completed
Last Updated

March 3, 2022

Status Verified

February 1, 2022

Enrollment Period

1 year

First QC Date

June 24, 2020

Last Update Submit

February 15, 2022

Conditions

Musculoskeletal Pain

Outcome Measures

Primary Outcomes (4)

  • 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

  • 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

  • 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

  • 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 Outcomes (2)

  • Questionnaires

    Changes from baseline measured at day 3 and day 8

  • Pressure pain thresholds

    Changes from baseline measured at day 3 and day 8

Study Arms (4)

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

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

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

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

Interventions

Nerve Growth FactorDRUG

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

Healthy musiciansHealthy non-musiciansMusicians with chronic painNon-musicians with chronic pain

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Healthy men and women Speak and understand English.

You may qualify if:

  • Healthy men and women Speak and understand English.

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aalborg University

Aalborg, North Denmark, 9000, Denmark

Location

Related Publications (1)

  • Zamorano AM, Kleber B, De Martino E, Insausti-Delgado A, Vuust P, Flor H, Graven-Nielsen T. Prior use-dependent plasticity triggers different individual corticomotor responses during persistent musculoskeletal pain. Pain. 2025 Jul 30. doi: 10.1097/j.pain.0000000000003749. Online ahead of print.

    PMID: 40728516DERIVED

MeSH Terms

Conditions

Musculoskeletal Pain

Interventions

Nerve Growth Factor

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Nerve Growth FactorsIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsNerve Tissue ProteinsBiological Factors

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 24, 2020

First Posted

July 7, 2020

Study Start

October 1, 2017

Primary Completion

October 1, 2018

Study Completion

July 1, 2020

Last Updated

March 3, 2022

Record last verified: 2022-02

Locations

DK(1)