Efficacy of Mindfulness Therapy in Orofacial Chronic Pain

Chronic Pain Clinical Trial

Official title:

Efficacy of Mindfulness Therapy in Orofacial Chronic Pain

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04765007
• Other study ID #: mindfulness Ujaen
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 4, 2021
• Est. completion date: October 7, 2021

Study information

• Verified date: April 2021
• Source: University of Jaén
• Contact: Yolanda Castellote
• Phone: +34953213519
• Email: mycastel[@]ujaen.es
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: October 7, 2021
• Est. primary completion date: May 4, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Patients diagnosed of orofacial chronic pain by a physician.

Exclusion Criteria:

• Pain with oncologic origin

• Severe mental disorder

Related Conditions & MeSH terms

• Chronic Pain
• Facial Pain
• Mindfulness
• Orofacial Pain

Intervention

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
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Jaén

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Impact of headache	Evaluation of the impact caused by headache using the Headache Impact Test (HIT-6)	pre-intervention
Primary	Impact of headache	Evaluation of the impact caused by headache using the Headache Impact Test (HIT-6)	8 weeks
Primary	Impact of headache	Evaluation of the impact caused by headache using the Headache Impact Test (HIT-6)	5 months
Primary	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
Primary	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
Primary	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
Primary	Dizziness-related disability	Evaluation of dizziness-related disability through Dizziness Handicap Inventory (DHI)	pre-intervention
Primary	Dizziness-related disability	Evaluation of dizziness-related disability through Dizziness Handicap Inventory (DHI)	8 weeks
Primary	Dizziness-related disability	Evaluation of dizziness-related disability through Dizziness Handicap Inventory (DHI)	5 months
Primary	Neck pain-related disability	Assessment of neck pain-related disability with Neck Disability Index (NDI)	pre-intervention
Primary	Neck pain-related disability	Assessment of neck pain-related disability with Neck Disability Index (NDI)	8 weeks
Primary	Neck pain-related disability	Assessment of neck pain-related disability with Neck Disability Index (NDI)	5 months