Efficacy of Mindfulness Therapy in Orofacial Chronic Pain

NCT04765007 | Unknown

• 1 other identifier: mindfulness Ujaen
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Mindfulness; Chronic Pain; Orofacial Pain

Keywords

mindfulness; chronic pain; orofacial pain

Outcome Measures

Primary Outcomes (24)

• 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.

  pre-intervention

• 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

  8 weeks

• 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

  5 months

• 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).

  pre-intervention

• 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).

  8 weeks

• 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).

  5 months

• 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.

  pre-intervention

• 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.

  8 weeks

• 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.

  5 months

• 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.

  pre-intervention

• 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.

  8 weeks

• 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.

  5 months

• Impact of headache

  Evaluation of the impact caused by headache using the Headache Impact Test (HIT-6)

  pre-intervention

• Impact of headache

  Evaluation of the impact caused by headache using the Headache Impact Test (HIT-6)

  8 weeks

• Impact of headache

  Evaluation of the impact caused by headache using the Headache Impact Test (HIT-6)

  5 months

• 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.

  pre-intervention

• 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.

  8 weeks

• 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.

  5 months

• Dizziness-related disability

  Evaluation of dizziness-related disability through Dizziness Handicap Inventory (DHI)

  pre-intervention

• Dizziness-related disability

  Evaluation of dizziness-related disability through Dizziness Handicap Inventory (DHI)

  8 weeks

• Dizziness-related disability

  Evaluation of dizziness-related disability through Dizziness Handicap Inventory (DHI)

  5 months

• Neck pain-related disability

  Assessment of neck pain-related disability with Neck Disability Index (NDI)

  pre-intervention

• Neck pain-related disability

  Assessment of neck pain-related disability with Neck Disability Index (NDI)

  8 weeks

• Neck pain-related disability

  Assessment of neck pain-related disability with Neck Disability Index (NDI)

  5 months

Study Arms (2)

Mindfulness group

EXPERIMENTAL

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

Other: mindfulness-based stress reduction

Control group

OTHER

This arm will be treated with a minimal intervention.

Other: Minimal intervention

Interventions

mindfulness-based stress reduction OTHER

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

Also known as: MBSR

Mindfulness group

Minimal intervention OTHER

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.

Control group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients diagnosed of orofacial chronic pain by a physician.

You may not qualify if:

• Pain with oncologic origin
• Severe mental disorder

Sponsors & Collaborators

• University of Jaén: lead

MeSH Terms

Conditions

Chronic Pain; Facial Pain

Interventions

Mindfulness-Based Stress Reduction

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mindfulness; Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Central Study Contacts

Yolanda Castellote

CONTACT

+34953213519; mycastel@ujaen.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physiotherapist

Study Record Dates

• First Submitted: February 2, 2021
• First Posted: February 21, 2021
• Study Start: May 4, 2021
• Primary Completion: May 4, 2021
• Study Completion: October 7, 2021
• Last Updated: May 3, 2021

Record last verified: 2021-04