Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Central Neuromodulation of Pain Through Music in Healthy Subjects (DOUMU1)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03914105
Recruitment Status : Recruiting
First Posted : April 16, 2019
Last Update Posted : December 23, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital, Brest

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.

Condition or disease Intervention/treatment Phase
Pain Procedure: Without music Procedure: With music Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Central Neuromodulation of Pain Through Music in Healthy Subjects (DOUMU1)
Actual Study Start Date : October 15, 2019
Estimated Primary Completion Date : April 15, 2020
Estimated Study Completion Date : April 15, 2020

Arm Intervention/treatment
Active Comparator: Without music
Test without music
Procedure: Without music
The starting condition will be "without music": the subjects, after a rest period of 10 minutes, will perform a test of induced pain for 6 minutes. There will be no music for the duration.

Experimental: With music Procedure: With music
The starting condition will be "with music": the subjects, after a rest period of 10 minutes, will perform a test of induced pain for 6 minutes. There will be music for the duration.




Primary Outcome Measures :
  1. Evaluation of Visual Analogue scale (VAS) [ Time Frame: 20 minutes ]

    Visual Analogue Scale (VAS) measured at 2 minutes of stimulation during the temporal summation phase, starting from a basic VAS calibrated at 50/100.

    Pain is assessed continuously throughout this test using a computerized analog visual scale.



Secondary Outcome Measures :
  1. Average VAS of the subject over the period P1 [ Time Frame: 2 minutes ]

    The period P1 represents the first stimulation or the first time summation test. It is a tonic pain test by applying the thermode. The average VAS will be measured during this period.

    Pain is assessed continuously throughout this test using a computerized analog visual scale.


  2. Average VAS of the subject over the period P2 [ Time Frame: 2 minutes ]

    The period P2 represents the second stimulation or activation of the DNIC (Diffuse Nociceptive Inhibitive Control). This is the induction of cold thermal nociceptive stimulation (CPT : cold pressor test). The average VAS will be measured during this period.

    Pain is assessed continuously throughout this test using a computerized analog visual scale.


  3. Average VAS of the subject over the period P3 [ Time Frame: 2 minutes ]

    The period P3 represents the third stimulation or the second time summation test. This is the second tonic pain test by applying the thermode.The average VAS will be measured during this period.

    Pain is assessed continuously throughout this test using a computerized analog visual scale.


  4. Evaluation of numerical scale [ Time Frame: 20 minutes ]

    Numerical scale (overall numerical scale over the period) will be measured for each stimulation period (P1, P2, P3).

    This scale assesses pain and is graded from 0 (no pain) to 100 (maximum pain imaginable).


  5. Difference in average VAS P1-P3 [ Time Frame: 20 minutes ]

    The difference in average VAS between period P1 and period P3 will be calculated.

    Pain is assessed continuously throughout this test using a computerized analog visual scale.


  6. Difference in Pressure Pain Threshold (PPT) before and after the procedure [ Time Frame: 1 hour and 30 minutes ]
    The difference in Pressure Pain Threshold (PPT) will be measured before and after the procedure.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03914105


Contacts
Layout table for location contacts
Contact: Céline Bodere, MD 02 98 34 73 08 ext +33 Celine.Bodere@univ-brest.fr

Locations
Layout table for location information
France
CHRU Brest Recruiting
Brest, France, 29200
Contact: Céline Bodere, MD    02 98 34 73 08 ext +33    Celine.Bodere@univ-brest.fr   
Sponsors and Collaborators
University Hospital, Brest
Investigators
Layout table for investigator information
Study Director: Gildas L'Heveder, MD Brest University Hospital in France
Principal Investigator: Céline Bodere, MD Brest University Hospital in France
Layout table for additonal information
Responsible Party: University Hospital, Brest
ClinicalTrials.gov Identifier: NCT03914105    
Other Study ID Numbers: DOUMU1 (29BRC19.0039)
First Posted: April 16, 2019    Key Record Dates
Last Update Posted: December 23, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: All collected data that underlie results in a publication
Supporting Materials: Study Protocol
Time Frame: Data will be available after the publication of result and ending fifteen years following the last visit of the last patient
Access Criteria: Data access requests will be reviewed by the internal committee of Brest UH. Requestors will be required to sign and complete a data access agreement.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No