Assessment of the Effects of Extensive Somatosensory Training on Pain Processing

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: Terminated
• Conditions: Musculoskeletal Pain
• Intervention / Treatment: Drug: Nerve Growth Factor

• Study Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Aalborg University
• Collaborators: University of Aarhus; Lundbeck Foundation; Danish National Research Foundation

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2017
• Primary Completion (Actual): October 1, 2018
• Study Completion (Actual): July 1, 2020

Study Registration Dates

• First Submitted: June 24, 2020
• First Submitted That Met QC Criteria: July 2, 2020
• First Posted (Actual): July 7, 2020

Study Record Updates

• Last Update Posted (Actual): March 3, 2022
• Last Update Submitted That Met QC Criteria: February 15, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Musculoskeletal Diseases; Muscular Diseases; Musculoskeletal Pain; Molecular Mechanisms of Pharmacological Action; Mitosis Modulators; Mitogens
• Other Study ID 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