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

NCT07147764 | Recruiting

• 1 other identifier: E-10840098-202.3.02-2936
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Temporomandibular Joint Disorders

Keywords

Temporomandibular Disorder; Pain Neuroscience Education; Chronic Pain

Outcome Measures

Primary Outcomes (1)

• 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.

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

Secondary Outcomes (8)

• Numeric Pain Rating Scale (NPRS)

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

• Pain Self-Efficacy Questionnaire (PSEQ)

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

• Pain Catastrophizing Scale (PCS)

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

• Hospital Anxiety and Depression Scale (HADS)

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

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

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

Study Arms (2)

Control group (CG): Physiotherapy

ACTIVE COMPARATOR

Other: Physiotherapy

Pain Neuroscience Group (PNEG): Physiotherapy + Pain Neuroscience Education

EXPERIMENTAL

Behavioral: Pain Neuroscience Education

Interventions

Physiotherapy OTHER

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

Control group (CG): Physiotherapy

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.

Pain Neuroscience Group (PNEG): Physiotherapy + Pain Neuroscience Education

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ainaz Shahedi: lead
• Medipol University: collaborator

Study Sites (1)

Istanbul Medipol University

Istanbul, Kavacik, 34810, Turkey (Türkiye)

RECRUITING

Related Publications (26)

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  BACKGROUND

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MeSH Terms

Conditions

Temporomandibular Joint Disorders; Chronic Pain

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation

Study Officials

• Gizem Ergezen Şahin, Dr. Assistant Professor

  Department of Physiotherapy and Rehabilitation/Istanbul Medipol University

  STUDY DIRECTOR

Central Study Contacts

Ainaz Shahedi, PT, MSc (Cand.)

CONTACT

+90-542-733-1783; shahediainaz1@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MSc Candidate in Physiotherapy, Istanbul Medipol University

Study Record Dates

• First Submitted: August 22, 2025
• First Posted: August 29, 2025
• Study Start: September 14, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: October 3, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)