About this trial
This research study aims to evaluate the effectiveness of Pain Neuroscience Education (PNE) when it is added to a physiotherapy program for people experiencing chronic temporomandibular disorders (TMD). To see whether adding PNE to physiotherapy program would provides additional benefits in reducing pain intensity, improving psychological well-being, and enhancing functional outcomes. The findings are expected to provide new insights into more comprehensive and patient-centered treatment strategies for managing chronic TMD.
Participants will be randomly assigned to one of two groups:
Control Group: Physiotherapy only
PNE Group: Physiotherapy plus Pain Neuroscience Education
Both groups will receive their respective treatments for a set period of time.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Diagnosed with pain-related TMDs according to DC/TMD guidelines
Chronic TMD pain, defined as experiencing pain for at least six months and feeling the pain during the last 30 days
Age between 18-65 years
Disqualifiers
Illiterate patients
Severe depression (medical diagnoses)
Previous diagnosis of uncontrolled psychiatric disorder neurodegenerative diseases
Clinical history of tumors in the craniofacial region
Trial design
Parallel
Treatments tested in this trial
Physiotherapy
Other interventionPhysiotherapy treatment programs include therapeutic ultrasound, muscle relaxation techniques, range of motion exercises, and joint and soft tissue mobilization.
Pain Neuroscience Education
BehavioralPNE sessions will be conducted in addition to physiotherapy programs for intervention groups. PNE sessions will occupy half of each session during the first two weeks. Physiotherapists trained in PNE will deliver sessions using a combination of metaphors, animated videos, and scientifically accurate descriptions. The same physiotherapist will lead both sessions with the same patient. Active learning techniques will include: Connecting new information with prior knowledge. Operationalizing key pain concepts into individual contexts. Facilitated problem-solving and critical reflection.
Treatment groups
Trial outcomes
Primary outcomes
The Craniofacial Pain and Disability Inventory (CF-PDI)
It consists of 21 items, with a score ranging from 0 to 63 points. Each question is scored on a 4-point ordinal scale, ranging from 0 to 3. A higher score reflects higher disability levels.
Secondary outcomes
Numeric Pain Rating Scale (NPRS)
It includes an 11-point numerical rating scale, ranging from 0, indicating (no pain), to 10, representing (the worst pain imaginable),.
Pain Self-Efficacy Questionnaire (PSEQ)
It consists of 10 items scored on a 7-point ordinal scale (ranging from 0: "not at all confident" to 6: "completely confident").
Pain Catastrophizing Scale (PCS)
It consists of 13 items for the assessment of catastrophizing thoughts. It is divided into three domains: helplessness, magnification, and rumination. Each item is scored on a 5-point ordinal scale. The PCS total score ranges from 0 to 52 points, higher values denote greater pain catastrophizing.
Hospital Anxiety and Depression Scale (HADS)
It comprises two subscales: HADS-Anxiety (HADS-A) and HADS-Depression (HADS-D), each consisting of seven items distributed throughout the questionnaire. Every item is rated on a 4-point Likert scale ranging from 0 to 3, reflecting the severity of symptoms. A score of 8 or above on either subscale is considered indicative of possible anxiety or depression.
Sponsors and contacts
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Ainaz Shahedi
Lead sponsor
Istanbul Medipol University Hospital
Sponsor institution
Medipol University
Collaborator