Efficacy of Mindfulness Therapy in Orofacial Chronic Pain

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Chronic Pain; Mindfulness; Orofacial Pain
• Intervention / Treatment: Other: mindfulness-based stress reduction; Other: Minimal intervention

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yolanda Castellote; Phone Number: +34953213519; Email: mycastel@ujaen.es

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients diagnosed of orofacial chronic pain by a physician.

Exclusion Criteria:

• Pain with oncologic origin
• Severe mental disorder

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mindfulness group; This arm will be treated with a mindfulness-based stress reduction therapy.	Other: mindfulness-based stress reduction; 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; Other Names: MBSR
Other: Control group; This arm will be treated with a minimal intervention.	Other: Minimal intervention; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Jaén

Study record dates

Study Major Dates

• Study Start (Anticipated): May 4, 2021
• Primary Completion (Anticipated): May 4, 2021
• Study Completion (Anticipated): October 7, 2021

Study Registration Dates

• First Submitted: February 2, 2021
• First Submitted That Met QC Criteria: February 18, 2021
• First Posted (Actual): February 21, 2021

Study Record Updates

• Last Update Posted (Actual): May 3, 2021
• Last Update Submitted That Met QC Criteria: April 28, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: chronic pain; mindfulness; orofacial pain
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chronic Pain; Facial Pain
• Other Study ID Numbers: mindfulness Ujaen

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No