Clinical trial NCT03914105: Central Neuromodulation of Pain Through Music in Healthy Subjects
Official title: Central Neuromodulation of Pain Through Music in Healthy Subjects (DOUMU1)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2019-04-16
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: The present research aims to study the neuromodulatory effect of music on the sensory component of pain. The activation of pain control systems, through music, would pave the way for rehabilitation prospects for patients with a deficit of these controls.

Detailed description: Pain is a multidimensional, complex and universal phenomenon that would be faced by almost one in two European adults. To meet the needs in terms of public health, contemporary medicine is gradually reintegrating the use of complementary therapeutic methods. Music therapy is a non-medical intervention that is particularly suited to pain problems. The therapeutic use of music is an economical, practical and safe method. Many clinical studies show that this activity promotes a significant decrease in pain. The ability of passive listening to music to reduce the perception of pain has been called "music-induced analgesia". The neuro-psycho-physiological mechanisms that underlie this phenomenon remain poorly understood. One hypothesis, still discussed, proposes that listening to music would stimulate, directly or indirectly, endogenous mechanisms of modulation of pain, stemming from the brainstem. In individuals undergoing nociceptive tonic stimulation, the specific neuronal activation induced by listening to music demonstrates the involvement of inhibitory descending pathways. A measurement of pain control mechanisms would account for the impact of music on central awareness.

The purpose of this research is therefore to study the neuromodulatory effect of music on the sensory component of pain. The activation of pain control systems, through music, would pave the way for rehabilitation prospects for patients with a deficit of these controls.

Eligibility criteria: Inclusion Criteria:

* Healthy subjects aged 18 to 65
* Subjects informed of the constraints of the study and having given their written consent.
* Subjects benefiting from a social security scheme.

Exclusion Criteria:

* Subjects under 18 and over 65
* Subjects who have previously participated in a pain study involving the induced pain test.
* Subjects with serious psychiatric disorders.
* Subjects with a diagnosis of acute or chronic pain.
* Subjects who have been taking antalgic substances for less than a week.
* Subjects with progressive disease not stabilized by medical treatment.
* Women in menstruation.
* Pregnant women.
* Subjects with a score greater than 10 for the Depressive Dimension on Hospital Anxiety and Depression Scale (HADS)
* Subjects with an anxiety score "state" higher than anxiety "traits" on the Spielberger condition state / traits anxiety inventory (STAI)
* Subjects with a score of 32 or higher on the Catastrophe Rating Scale (PCS-CF)
* Non-cooperating person.
* Person under legal protection
* Subjects not benefiting from a social security scheme
* Refusal of participation

Primary outcomes:
measure: Evaluation of Visual Analogue scale (VAS)
timeFrame: 20 minutes
Secondary outcomes:
measure: Average VAS of the subject over the period P1
timeFrame: 2 minutes
measure: Average VAS of the subject over the period P2
timeFrame: 2 minutes
measure: Average VAS of the subject over the period P3
timeFrame: 2 minutes
measure: Evaluation of numerical scale
timeFrame: 20 minutes
measure: Difference in average VAS P1-P3
timeFrame: 20 minutes
measure: Difference in Pressure Pain Threshold (PPT) before and after the procedure
timeFrame: 1 hour and 30 minutes
Other outcomes:
Locations:
city: Brest
country: France
facility: CHRU Brest
Study officials:
affiliation: Brest University Hospital in France
name: Gildas L'Heveder, MD
role: STUDY_DIRECTOR
affiliation: Brest University Hospital in France
name: Céline Bodere, MD
role: PRINCIPAL_INVESTIGATOR
References: