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Efficacy of Mindfulness Therapy in Orofacial Chronic Pain

Primary Purpose

Mindfulness, Chronic Pain, Orofacial Pain

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
mindfulness-based stress reduction
Minimal intervention
Sponsored by
University of Jaén
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mindfulness focused on measuring mindfulness, chronic pain, orofacial pain

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients diagnosed of orofacial chronic pain by a physician.

Exclusion Criteria:

  • Pain with oncologic origin
  • Severe mental disorder

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Other

    Arm Label

    Mindfulness group

    Control group

    Arm Description

    This arm will be treated with a mindfulness-based stress reduction therapy.

    This arm will be treated with a minimal intervention.

    Outcomes

    Primary Outcome Measures

    orofacial pain intensity
    mean of orofacial pain in the last seven days evaluated with Numeric Pain Rating Scale (NPRS). A scale from 0 to 10, where 0 is considered as no pain and 10 as the worst pain.
    orofacial pain intensity
    mean of orofacial pain in the last seven days evaluated with Numeric Pain Rating Scale (NPRS). A scale from 0 to 10, where 0 is considered as no pain and 10 as the worst pain
    orofacial pain intensity
    mean of orofacial pain in the last seven daysevaluated with Numeric Pain Rating Scale (NPRS). A scale from 0 to 10, where 0 is considered as no pain and 10 as the worst pain
    Symptoms of temporomandibular disorders
    Evaluation of the presence or absence of symptoms caused by temporomandibular disorders and their severity evaluated with Fonseca Anamnestic Index (FAI).
    Symptoms of temporomandibular disorders
    Evaluation of the presence or absence of symptoms caused by temporomandibular disorders and their severity evaluated with Fonseca Anamnestic Index (FAI).
    Symptoms of temporomandibular disorders
    Evaluation of the presence or absence of symptoms caused by temporomandibular disorders and their severity evaluated with Fonseca Anamnestic Index (FAI).
    Catastrophization of pain
    Evaluation of pain catastrophization through Pain Catastrophizing Scale (PCS). The PCS is a 13-item self-report questionnaire. Each item is scored from 0 (not at all) to 4 (always), and scores range from 0 to 52.
    Catastrophization of pain
    Evaluation of pain catastrophization through Pain Catastrophizing Scale (PCS). The PCS is a 13-item self-report questionnaire. Each item is scored from 0 (not at all) to 4 (always), and scores range from 0 to 52.
    Catastrophization of pain
    Evaluation of pain catastrophization through Pain Catastrophizing Scale (PCS). The PCS is a 13-item self-report questionnaire. Each item is scored from 0 (not at all) to 4 (always), and scores range from 0 to 52.
    Kinesiophobia
    Assessment of fear of movement in temporomandibular disorders evaluated with Tampa Scale of Kinesiophobia for Temporomandibular Disroders (TSK-TMD). The TSK-TMD is an 18-item self-report questionnaire, where the degree of agreement with each of the presented statements is recorded on a response scale from 1 (completely disagree) to 4 (completely agree). The scores are summed to provide a total score, with higher values reflecting greater kinesiophobia.
    Kinesiophobia
    Assessment of fear of movement in temporomandibular disorders evaluated with Tampa Scale of Kinesiophobia for Temporomandibular Disroders (TSK-TMD). The TSK-TMD is an 18-item self-report questionnaire, where the degree of agreement with each of the presented statements is recorded on a response scale from 1 (completely disagree) to 4 (completely agree). The scores are summed to provide a total score, with higher values reflecting greater kinesiophobia.
    Kinesiophobia
    Assessment of fear of movement in temporomandibular disorders evaluated with Tampa Scale of Kinesiophobia for Temporomandibular Disroders (TSK-TMD). The TSK-TMD is an 18-item self-report questionnaire, where the degree of agreement with each of the presented statements is recorded on a response scale from 1 (completely disagree) to 4 (completely agree). The scores are summed to provide a total score, with higher values reflecting greater kinesiophobia.
    Impact of headache
    Evaluation of the impact caused by headache using the Headache Impact Test (HIT-6)
    Impact of headache
    Evaluation of the impact caused by headache using the Headache Impact Test (HIT-6)
    Impact of headache
    Evaluation of the impact caused by headache using the Headache Impact Test (HIT-6)
    Sleep quality
    Assessment of sleep quality with the Medical Outcomes Study Sleep Scale (MOS-SS). the MOS-SS is a self-administered questionnaire comprised of 12 items in six different domains or sub-scales.
    Sleep quality
    Assessment of sleep quality with the Medical Outcomes Study Sleep Scale (MOS-SS). the MOS-SS is a self-administered questionnaire comprised of 12 items in six different domains or sub-scales.
    Sleep quality
    Assessment of sleep quality with the Medical Outcomes Study Sleep Scale (MOS-SS). the MOS-SS is a self-administered questionnaire comprised of 12 items in six different domains or sub-scales.
    Dizziness-related disability
    Evaluation of dizziness-related disability through Dizziness Handicap Inventory (DHI)
    Dizziness-related disability
    Evaluation of dizziness-related disability through Dizziness Handicap Inventory (DHI)
    Dizziness-related disability
    Evaluation of dizziness-related disability through Dizziness Handicap Inventory (DHI)
    Neck pain-related disability
    Assessment of neck pain-related disability with Neck Disability Index (NDI)
    Neck pain-related disability
    Assessment of neck pain-related disability with Neck Disability Index (NDI)
    Neck pain-related disability
    Assessment of neck pain-related disability with Neck Disability Index (NDI)

    Secondary Outcome Measures

    Full Information

    First Posted
    February 2, 2021
    Last Updated
    April 28, 2021
    Sponsor
    University of Jaén
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04765007
    Brief Title
    Efficacy of Mindfulness Therapy in Orofacial Chronic Pain
    Official Title
    Efficacy of Mindfulness Therapy in Orofacial Chronic Pain
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2021
    Overall Recruitment Status
    Unknown status
    Study Start Date
    May 4, 2021 (Anticipated)
    Primary Completion Date
    May 4, 2021 (Anticipated)
    Study Completion Date
    October 7, 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Jaén

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Psychological impairments have a significant role in management and coping of pain in patients with orofacial pain disorders. The response of this kind of pathologies to topical or systemic medications is not predictable and mindfulness breathing and relaxation techniques could present good results since it help patients to accept their problem and to cope it. In consequence, the present study is aimed to evaluate the efficacy of a mindfulness therapy program in management of chronic orofacial pain.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Mindfulness, Chronic Pain, Orofacial Pain
    Keywords
    mindfulness, chronic pain, orofacial pain

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    40 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Mindfulness group
    Arm Type
    Experimental
    Arm Description
    This arm will be treated with a mindfulness-based stress reduction therapy.
    Arm Title
    Control group
    Arm Type
    Other
    Arm Description
    This arm will be treated with a minimal intervention.
    Intervention Type
    Other
    Intervention Name(s)
    mindfulness-based stress reduction
    Other Intervention Name(s)
    MBSR
    Intervention Description
    Eight sessions of two hours and a half, one day per week during eight weeks. In addition, patients will perform a day of intensive silent practice of 6-8 hours of duration. The content of each session balances three activities: the presentation of a topic, moments of dialogue and group exploration (using appreciative inquiry) and a Mindfulness practice. The sessions will take place in online format, through the google meet application
    Intervention Type
    Other
    Intervention Name(s)
    Minimal intervention
    Intervention Description
    A guided meditation program of eight weeks of duration will be provided to the patients and they will be informed about the procedure and the beneficial effects of the therapy.
    Primary Outcome Measure Information:
    Title
    orofacial pain intensity
    Description
    mean of orofacial pain in the last seven days evaluated with Numeric Pain Rating Scale (NPRS). A scale from 0 to 10, where 0 is considered as no pain and 10 as the worst pain.
    Time Frame
    pre-intervention
    Title
    orofacial pain intensity
    Description
    mean of orofacial pain in the last seven days evaluated with Numeric Pain Rating Scale (NPRS). A scale from 0 to 10, where 0 is considered as no pain and 10 as the worst pain
    Time Frame
    8 weeks
    Title
    orofacial pain intensity
    Description
    mean of orofacial pain in the last seven daysevaluated with Numeric Pain Rating Scale (NPRS). A scale from 0 to 10, where 0 is considered as no pain and 10 as the worst pain
    Time Frame
    5 months
    Title
    Symptoms of temporomandibular disorders
    Description
    Evaluation of the presence or absence of symptoms caused by temporomandibular disorders and their severity evaluated with Fonseca Anamnestic Index (FAI).
    Time Frame
    pre-intervention
    Title
    Symptoms of temporomandibular disorders
    Description
    Evaluation of the presence or absence of symptoms caused by temporomandibular disorders and their severity evaluated with Fonseca Anamnestic Index (FAI).
    Time Frame
    8 weeks
    Title
    Symptoms of temporomandibular disorders
    Description
    Evaluation of the presence or absence of symptoms caused by temporomandibular disorders and their severity evaluated with Fonseca Anamnestic Index (FAI).
    Time Frame
    5 months
    Title
    Catastrophization of pain
    Description
    Evaluation of pain catastrophization through Pain Catastrophizing Scale (PCS). The PCS is a 13-item self-report questionnaire. Each item is scored from 0 (not at all) to 4 (always), and scores range from 0 to 52.
    Time Frame
    pre-intervention
    Title
    Catastrophization of pain
    Description
    Evaluation of pain catastrophization through Pain Catastrophizing Scale (PCS). The PCS is a 13-item self-report questionnaire. Each item is scored from 0 (not at all) to 4 (always), and scores range from 0 to 52.
    Time Frame
    8 weeks
    Title
    Catastrophization of pain
    Description
    Evaluation of pain catastrophization through Pain Catastrophizing Scale (PCS). The PCS is a 13-item self-report questionnaire. Each item is scored from 0 (not at all) to 4 (always), and scores range from 0 to 52.
    Time Frame
    5 months
    Title
    Kinesiophobia
    Description
    Assessment of fear of movement in temporomandibular disorders evaluated with Tampa Scale of Kinesiophobia for Temporomandibular Disroders (TSK-TMD). The TSK-TMD is an 18-item self-report questionnaire, where the degree of agreement with each of the presented statements is recorded on a response scale from 1 (completely disagree) to 4 (completely agree). The scores are summed to provide a total score, with higher values reflecting greater kinesiophobia.
    Time Frame
    pre-intervention
    Title
    Kinesiophobia
    Description
    Assessment of fear of movement in temporomandibular disorders evaluated with Tampa Scale of Kinesiophobia for Temporomandibular Disroders (TSK-TMD). The TSK-TMD is an 18-item self-report questionnaire, where the degree of agreement with each of the presented statements is recorded on a response scale from 1 (completely disagree) to 4 (completely agree). The scores are summed to provide a total score, with higher values reflecting greater kinesiophobia.
    Time Frame
    8 weeks
    Title
    Kinesiophobia
    Description
    Assessment of fear of movement in temporomandibular disorders evaluated with Tampa Scale of Kinesiophobia for Temporomandibular Disroders (TSK-TMD). The TSK-TMD is an 18-item self-report questionnaire, where the degree of agreement with each of the presented statements is recorded on a response scale from 1 (completely disagree) to 4 (completely agree). The scores are summed to provide a total score, with higher values reflecting greater kinesiophobia.
    Time Frame
    5 months
    Title
    Impact of headache
    Description
    Evaluation of the impact caused by headache using the Headache Impact Test (HIT-6)
    Time Frame
    pre-intervention
    Title
    Impact of headache
    Description
    Evaluation of the impact caused by headache using the Headache Impact Test (HIT-6)
    Time Frame
    8 weeks
    Title
    Impact of headache
    Description
    Evaluation of the impact caused by headache using the Headache Impact Test (HIT-6)
    Time Frame
    5 months
    Title
    Sleep quality
    Description
    Assessment of sleep quality with the Medical Outcomes Study Sleep Scale (MOS-SS). the MOS-SS is a self-administered questionnaire comprised of 12 items in six different domains or sub-scales.
    Time Frame
    pre-intervention
    Title
    Sleep quality
    Description
    Assessment of sleep quality with the Medical Outcomes Study Sleep Scale (MOS-SS). the MOS-SS is a self-administered questionnaire comprised of 12 items in six different domains or sub-scales.
    Time Frame
    8 weeks
    Title
    Sleep quality
    Description
    Assessment of sleep quality with the Medical Outcomes Study Sleep Scale (MOS-SS). the MOS-SS is a self-administered questionnaire comprised of 12 items in six different domains or sub-scales.
    Time Frame
    5 months
    Title
    Dizziness-related disability
    Description
    Evaluation of dizziness-related disability through Dizziness Handicap Inventory (DHI)
    Time Frame
    pre-intervention
    Title
    Dizziness-related disability
    Description
    Evaluation of dizziness-related disability through Dizziness Handicap Inventory (DHI)
    Time Frame
    8 weeks
    Title
    Dizziness-related disability
    Description
    Evaluation of dizziness-related disability through Dizziness Handicap Inventory (DHI)
    Time Frame
    5 months
    Title
    Neck pain-related disability
    Description
    Assessment of neck pain-related disability with Neck Disability Index (NDI)
    Time Frame
    pre-intervention
    Title
    Neck pain-related disability
    Description
    Assessment of neck pain-related disability with Neck Disability Index (NDI)
    Time Frame
    8 weeks
    Title
    Neck pain-related disability
    Description
    Assessment of neck pain-related disability with Neck Disability Index (NDI)
    Time Frame
    5 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients diagnosed of orofacial chronic pain by a physician. Exclusion Criteria: Pain with oncologic origin Severe mental disorder
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Yolanda Castellote
    Phone
    +34953213519
    Email
    mycastel@ujaen.es

    12. IPD Sharing Statement

    Learn more about this trial

    Efficacy of Mindfulness Therapy in Orofacial Chronic Pain

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