Assessment of the Effects of Extensive Somatosensory Training on Pain Processing

February 15, 2022 updated by: Anna M. Zamorano, Aalborg University

Assessment of the Effects of Extensive Sensorimotor Training on Pain Processing

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
    • Nordjylland
      • Aalborg, Nordjylland, Denmark, 9000
        • Aalborg University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Healthy men and women Speak and understand English.

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Pain rating
Time Frame: 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)
Changes from baseline measured at day 3 and day 8
Cortical Sensory Evoked Potentials
Time Frame: Changes from baseline measured at day 3 and day 8
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
Time Frame: Changes from baseline measured at day 3 and day 8
Transcranial magnetic stimualtion will be used to evoke motor evoked potentials (MEPs)
Changes from baseline measured at day 3 and day 8
Brain connectivity
Time Frame: Changes from baseline measured at day 3 and day 8
Continuous electroencephalography recording will be used to explore connectivity between brain areas
Changes from baseline measured at day 3 and day 8

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Questionnaires
Time Frame: Changes from baseline measured at day 3 and day 8
Questionnaires about pain and muscle soreness (Pain catastrophization; State and Trait anxiety; Pain vigilance)
Changes from baseline measured at day 3 and day 8
Pressure pain thresholds
Time Frame: Changes from baseline measured at day 3 and day 8
Pressure applied to the surface of the skin using a handheld algometer
Changes from baseline measured at day 3 and day 8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Aalborg University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Aarhus
Lundbeck Foundation
Danish National Research Foundation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 24, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 2, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 7, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 3, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 15, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 10042017

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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