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Clinical Trials/NCT04765007
NCT04765007
Unknown
Not Applicable

Efficacy of Mindfulness Therapy in Orofacial Chronic Pain

University of Jaén0 sites40 target enrollmentMay 4, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Mindfulness
Sponsor
University of Jaén
Enrollment
40
Primary Endpoint
orofacial pain intensity
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 4, 2021
End Date
October 7, 2021
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
University of Jaén
Responsible Party
Principal Investigator
Principal Investigator

Daniel Rodríguez Almagro

Physiotherapist

University of Jaén

Eligibility Criteria

Inclusion Criteria

  • Patients diagnosed of orofacial chronic pain by a physician.

Exclusion Criteria

  • Pain with oncologic origin
  • Severe mental disorder

Outcomes

Primary Outcomes

orofacial pain intensity

Time Frame: 5 months

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

Time Frame: 5 months

Evaluation of the presence or absence of symptoms caused by temporomandibular disorders and their severity evaluated with Fonseca Anamnestic Index (FAI).

Dizziness-related disability

Time Frame: 5 months

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

Catastrophization of pain

Time Frame: 5 months

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

Time Frame: 5 months

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.

Sleep quality

Time Frame: 5 months

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.

Neck pain-related disability

Time Frame: 5 months

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

Impact of headache

Time Frame: 5 months

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

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