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NCT Number: NCT07147764

Comparison of the Effect of Pain Neuroscience Education Combined With Physiotherapy, and Physiotherapy Alone in Temporomandibular Disorders

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.

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Key information

Conditions

Temporomandibular Joint Disorders Chronic Pain Craniomandibular Disorders Jaw Diseases Joint Diseases Mandibular Diseases Muscular Diseases Musculoskeletal Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Stomatognathic Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istanbul Medipol University

Istanbul, Kavacik, 34810, Turkey (Türkiye)

Location status: Recruiting

Location contact

Ainaz Shahedi

CONTACT

[email protected]

+905427331783

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • Illiterate patients
  • Severe depression (medical diagnoses)
  • Previous diagnosis of uncontrolled psychiatric disorder neurodegenerative diseases
  • Clinical history of tumors in the craniofacial region
  • Patients in the post dental surgery period
  • Patients who were submitted to previous physical therapy in the past year or to any health/pain education strategy
  • Pregnant women
  • Infections, whiplash-associated disorders and with chronic degenerative inflammatory or neurologic disorders

Treatment and study plan

Physiotherapy

Other

Physiotherapy treatment programs include therapeutic ultrasound, muscle relaxation techniques, range of motion exercises, and joint and soft tissue mobilization.

pain neuroscience education

Behavioral

PNE 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.

Primary outcomes

  1. The Craniofacial Pain and Disability Inventory (CF-PDI)

    Time frame: Baseline, 1 month after start of treatment, Immediate post-treatment, 3 month follow up

    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

  1. Numeric Pain Rating Scale (NPRS)

    Time frame: Baseline, 1 month after start of treatment, Immediate post-treatment, 3 month follow up

    It includes an 11-point numerical rating scale, ranging from 0, indicating (no pain), to 10, representing (the worst pain imaginable),.

  2. Pain Self-Efficacy Questionnaire (PSEQ)

    Time frame: Baseline, 1 month after start of treatment, Immediate post-treatment, 3 month follow up

    It consists of 10 items scored on a 7-point ordinal scale (ranging from 0: "not at all confident" to 6: "completely confident").

  3. Pain Catastrophizing Scale (PCS)

    Time frame: Baseline,1 month after start of treatment, Immediate post-treatment, 3 month follow up

    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.

  4. Hospital Anxiety and Depression Scale (HADS)

    Time frame: Baseline, 1 month after start of treatment, Immediate post-treatment, 3 month follow up

    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.

  5. The Tampa Scale for Kinesiophobia specific to Temporomandibular Disorders (TSK-TMD)

    Time frame: Baseline, 1 month after start of treatment, Immediate post-treatment, 3 month follow up

    It consists of 12 items. Each item is scored on a 4-point ordinal scale, ranging from "strongly disagree" (score = 1) to "strongly agree" (score = 4). Ratings are summed to yield a total score. Higher scores reflect a greater fear of movement (12-48 points).

  6. Revised Neurophysiology of Pain Questionnaire (rNPQ)

    Time frame: Baseline, 1 month after start of treatment, Immediate post-treatment, 3 month follow up

    It includes 12 items, each requiring a true, false, or undecided response. Each correct answer receives one point, while incorrect or undecided answers receive zero. Total scores range from 0 to 12, with higher scores reflecting greater knowledge of pain-related physiological concepts.

  7. The Exercise Adherence Rating Scale (EARS)

    Time frame: Baseline, 1 month after start of treatment, Immediate post-treatment, 3 month follow up

    The tool consists of six items rated on a five-point Likert scale, ranging from 0 (strongly agree) to 4 (totally disagree). Items with positively worded statements are reverse-scored to maintain consistency in interpretation. The total adherence score ranges from 0 to 24, with higher scores indicating greater adherence to the exercise regimen.

  8. Fear Avoidance Components Scale (FACS)

    Time frame: Baseline, 1 month after start of treatment, Immediate post-treatment, 3 month follow up

    This self-administered questionnaire comprises 20 items rated on a 6-point Likert scale, ranging from 0 (completely disagree) to 6 (completely agree), yielding a maximum score of 100. Higher scores indicate stronger fear-avoidance beliefs.

Study contacts

Contact information is provided by the study sponsor or research team.

Ainaz Shahedi, PT, MSc (Cand.)

CONTACT

[email protected]

+90-542-733-1783

Sponsors and collaborators

Lead sponsor

Ainaz Shahedi

Other

Collaborators

  • Medipol University

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 29, 2025
Registry last updated
Oct 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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