Musculoskeletal Pain Clinical Trial
Official title:
Assessment of the Effects of Extensive Sensorimotor Training on Pain Processing
NCT number | NCT04457466 |
Other study ID # | 10042017 |
Secondary ID | |
Status | Terminated |
Phase | |
First received | |
Last updated | |
Start date | October 1, 2017 |
Est. completion date | July 1, 2020 |
Verified date | February 2022 |
Source | Aalborg University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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) |
Country | Name | City | State |
---|---|---|---|
Denmark | Aalborg University | Aalborg | Nordjylland |
Lead Sponsor | Collaborator |
---|---|
Aalborg University | Danish National Research Foundation, Lundbeck Foundation, University of Aarhus |
Denmark,
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 |
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