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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorAinaz Shahedi

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Physiotherapy

    Other intervention

    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.

Treatment groups

36 Participants
are divided into 2 treatment groups
Group A: Control group (CG): PhysiotherapyActive comparator 1 intervention
Group B: Pain Neuroscience Group (PNEG): Physiotherapy + Pain Neuroscience EducationExperimental treatment 1 intervention

Trial outcomes

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.

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

Secondary outcomes

1

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),.

Time frame
Baseline, 1 month after start of treatment, Immediate post-treatment, 3 month follow up
2

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").

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

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.

Time frame
Baseline,1 month after start of treatment, Immediate post-treatment, 3 month follow up
4

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.

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ainaz Shahedi

Lead sponsor

Istanbul Medipol University Hospital

Sponsor institution

Medipol University

Collaborator