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

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07147764
Enrollment
36
Registered
2025-08-29
Start date
2025-09-14
Completion date
2026-06-30
Last updated
2025-10-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Temporomandibular Joint Disorders

Keywords

Temporomandibular Disorder, Pain Neuroscience Education, Chronic Pain

Brief summary

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.

Interventions

OTHERPhysiotherapy

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

BEHAVIORALPain Neuroscience Education

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.

Sponsors

Medipol University
CollaboratorOTHER
Ainaz Shahedi
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
The Craniofacial Pain and Disability Inventory (CF-PDI)Baseline, 1 month after start of treatment, Immediate post-treatment, 3 month follow upIt 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

MeasureTime frameDescription
Pain Self-Efficacy Questionnaire (PSEQ)Baseline, 1 month after start of treatment, Immediate post-treatment, 3 month follow upIt 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)Baseline,1 month after start of treatment, Immediate post-treatment, 3 month follow upIt 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)Baseline, 1 month after start of treatment, Immediate post-treatment, 3 month follow upIt 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.
Numeric Pain Rating Scale (NPRS)Baseline, 1 month after start of treatment, Immediate post-treatment, 3 month follow upIt includes an 11-point numerical rating scale, ranging from 0, indicating (no pain), to 10, representing (the worst pain imaginable),.
Revised Neurophysiology of Pain Questionnaire (rNPQ)Baseline, 1 month after start of treatment, Immediate post-treatment, 3 month follow upIt 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.
The Exercise Adherence Rating Scale (EARS)Baseline, 1 month after start of treatment, Immediate post-treatment, 3 month follow upThe 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.
Fear Avoidance Components Scale (FACS)Baseline, 1 month after start of treatment, Immediate post-treatment, 3 month follow upThis 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.
The Tampa Scale for Kinesiophobia specific to Temporomandibular Disorders (TSK-TMD)Baseline, 1 month after start of treatment, Immediate post-treatment, 3 month follow upIt 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).

Countries

Turkey (Türkiye)

Contacts

Primary ContactAinaz Shahedi, PT, MSc (Cand.)
shahediainaz1@gmail.com+90-542-733-1783

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026