Musculoskeletal PainNCT04457466
Assessment of the Effects of Extensive Somatosensory Training on Pain Processing
An observational study of Musculoskeletal Pain, run by Aalborg University at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Musculoskeletal Pain
- What is being tested?
- Nerve Growth Factor
- Type of treatment
- Injection or infusion
- How many people
- 100 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Oct 2017to 1 Jul 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Healthy men and women Speak and understand English.
Who may be able to join
- 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)
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Musculoskeletal Pain
- Being tested
- Nerve Growth Factor
- Medical subject headings
- Musculoskeletal Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nerve Growth FactorDrug
Induction of experimental muscle soreness using intramuscular injections of Nerve Growth Factor.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: Drug: Nerve Growth Factor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain rating
Pain on an 11-point numerical rating scale (0 = no pain, 10 = most intense pain imaginable)
Measured: 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)
Measured: 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)
Measured: Changes from baseline measured at day 3 and day 8
Brain connectivity
Continuous electroencephalography recording will be used to explore connectivity between brain areas
Measured: Changes from baseline measured at day 3 and day 8
Secondary outcomes (2)
Questionnaires
Questionnaires about pain and muscle soreness (Pain catastrophization; State and Trait anxiety; Pain vigilance)
Measured: 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
Measured: Changes from baseline measured at day 3 and day 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2020
- Study start1 Oct 2017
- Primary completion1 Oct 2018
- Study completion1 Jul 2020
Why it stopped: Covid-19
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Musculoskeletal PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aalborg University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Aarhus, Lundbeck Foundation, Danish National Research Foundation
- Responsible party
- Principal investigator, Anna M. Zamorano, Aalborg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04457466
- Sponsor's protocol ID
- 10042017
- Status last verified
- Feb 2022
- First submitted
- 24 Jun 2020
- Last updated
- 3 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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 Dec 1;166(12):e856-e863. doi: 10.1097/j.pain.0000000000003749. Epub 2025 Jul 30.
PubMed 40728516
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Effects of Extensive Sensorimotor Training on Pain Processing
- ClinicalTrials.gov ID
- NCT04457466
- Acronym / sponsor ID
- 10042017
- Conditions
- Musculoskeletal Pain
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Covid-19
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Aalborg UniversityUniversity, hospital or other
- Collaborators
- University of Aarhus, Lundbeck Foundation, Danish National Research Foundation
- Study start
- 1 Oct 2017 (actual)
- Primary completion
- 1 Oct 2018 (actual)
- Study completion
- 1 Jul 2020 (actual)
- First posted
- 7 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Healthy musicians | – | Drug: Nerve Growth FactorMen 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. |
| Healthy non-musicians | – | Drug: Nerve Growth FactorMen and women aged 18-60, must speak and understand English and not have any kind of musical training. |
| Musicians with chronic pain | – | Drug: Nerve Growth FactorMen 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. |
| Non-musicians with chronic pain | – | Drug: Nerve Growth FactorMen 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Healthy men and women Speak and understand English.
Key inclusion criteria (8 listed)
- Healthy men and women Speak and understand English.
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nerve Growth FactorInduction of experimental muscle soreness using intramuscular injections of Nerve Growth Factor. | Drug | Healthy musicians, Healthy non-musicians, Musicians with chronic pain, Non-musicians with chronic pain |
Primary outcome
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)
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)
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)
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
2 secondary outcomes
Questionnaires
Time frame: 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
Results and safety
The study was stopped early (reason given: Covid-19). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2022.
- Derived from this study: PubMed 40728516Zamorano 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 Dec 1;166(12):e856-e863. doi: 10.1097/j.pain.0000000000003749. Epub 2025 Jul 30.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Musculoskeletal Pain, run by Aalborg University at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 3 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Covid-19). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain rating (time frame: Changes from baseline measured at day 3 and day 8). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04457466, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2022; AzTrials last refreshed its copy on 8 Nov 2026.