NCT02427113

Brief Summary

The purpose of the study will be to examine the effectiveness of an innovative use of music on TMD. Music and rhythmic vibrations can alter the basic processes related to sensation of pain in the brain. As well, music can block the neurological pathways that transmit pain sensations and thereby reduce pain. Music and vibrations are relaxing, reduce stress, and thereby reduce sensitivity to pain.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2015

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 25, 2015

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 27, 2015

Completed
4 days until next milestone

Study Start

First participant enrolled

May 1, 2015

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

May 12, 2016

Status Verified

May 1, 2016

Enrollment Period

1.1 years

First QC Date

March 25, 2015

Last Update Submit

May 10, 2016

Conditions

Keywords

TMDMusic MedicineVibroacousitc Therapy

Outcome Measures

Primary Outcomes (1)

  • Visual Analog Scale to measure pain levels

    A psychometric response scale which can be used in questionnaires to measure participants pain levels.

    3 months

Secondary Outcomes (1)

  • Short Inventory Depression Scale

    3 months

Other Outcomes (2)

  • Mult-Dimensional Mood Questionnaire

    3 months

  • Quality of Life Enjoyment and Satisfaction Questionnaire

    3 months

Study Arms (2)

Self-Select Music

ACTIVE COMPARATOR

Participants will be randomized to two groups. Self-select music will be used as treatment for managing pain. They will be required to listen to their preferred songs for 30 minutes per 7 days, recommended 5, for 3 weeks.

Other: Self-Select Music

Sound Oasis Vibrating Chair

ACTIVE COMPARATOR

Participants will be randomized to two groups. Vibroacoustic therapy will be administered in the form of a vibrating chair. They will be required to listen to their preferred songs for 30 minutes per 7 days, recommended 5, for 3 weeks.

Other: Sound Oasis Vibrating Chair

Interventions

Sound oasis vibroacoustic chair will be used as treatment for managing TMD related pain

Sound Oasis Vibrating Chair

The self-select music of the participants will be applied for managing the painful symptoms of TMD

Self-Select Music

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • hearing able as listening to music is required as part of treatment
  • main source of pain is myofascial pain
  • on-going pain for 6 months

You may not qualify if:

  • Acute Inflammatory Conditions - an inflammation having a rapid onset, with a clear and distinct termination. (e.g. Rheumatoid arthritis and Osteoarthritis)
  • Clients Presenting with Psychoses
  • Pregnancy
  • Hemorrhaging or Active Bleeding
  • Thrombosis
  • Hypotension
  • Pacemakers as contraindications of Vibroacoustic Therapy (VAT) are related to these conditions.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mount Sinai Hospital's Wasser Pain Management Centre

Toronto, Ontario, Canada

RECRUITING

Study Officials

  • Dr. Allan Gordon, PhD

    MOUNT SINAI HOSPITAL

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Allan Gordon, PhD

CONTACT

Alicia A Howard, PhD Candiate

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD Candidate, University of Toronto

Study Record Dates

First Submitted

March 25, 2015

First Posted

April 27, 2015

Study Start

May 1, 2015

Primary Completion

June 1, 2016

Study Completion

July 1, 2016

Last Updated

May 12, 2016

Record last verified: 2016-05

Locations