Efficacy of Mindfulness Therapy in Orofacial Chronic Pain

Study Overview
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Brief Summary
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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.

Official Title
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Efficacy of Mindfulness Therapy in Orofacial Chronic Pain

Conditions
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Mindfulness, Chronic Pain, Orofacial Pain

Intervention / Treatment
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* Other: mindfulness-based stress reduction
* Other: Minimal intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients diagnosed of orofacial chronic pain by a physician. Exclusion Criteria: Pain with oncologic origin Severe mental disorder

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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mindfulness, chronic pain, orofacial pain