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Completed

NCT Number: NCT06087432

Is PNF Application Effective on Temporomandibular Dysfunction

The goal of this clinical trial is to compare effects of Rocabado exercises which is conventional physiotherapy treatment alone vs. combine it with proprioceptive neuromuscular facilitation (PNF) in people with temporomandibular dysfunction (TMD) with forward head posture. The main question aims to answer:

- Does adding neck and jaw PNF techniques to the treatment affect the pain and functional status of the jaw compared to Rocabado exercises alone?

Participants will be randomized into two groups (Group 1: only Rocabado exercises, Group 2: Rocabado + PNF) and perform 8 weeks long exercises. They will be assessed in the beginning of the study and at the end of the 8th week.

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Key information

Conditions

TMD 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 TMJ Disorder Temporomandibular Joint Disorders

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Gizem Ergezen

Istanbul, Beykoz, 34810, Turkey (Türkiye)

About this study

Infrared heat will be applied to the neck and face areas for 15 minutes for individuals with TMD with forward head posture in both groups. Then Group 1 will perform Rocabado exercises only, and Group 2 will perform PNF exercises in addition to Rocabado exercises. Exercises will be demonstrated and applied by a physiotherapist at the university clinic.

Pain intensity, pain threshold, TMJ functions, joint range of motion and Mandibular Function are among the parameters to be evaluated. All evaluations will be made by a blinded evaluator at baseline (baseline t=0), before exercise and after exercise (post-exercise, t=8.week).

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Diagnosis of TMD according to the diagnostic criteria for temporomandibular disorders (RDC/TMD),
  • Presence of trigger points in the relevant muscles,
  • Presence of pain

Exclusion criteria

  • Intra-articular or degenerative joint disorders and subluxation requiring urgent treatment;
  • History of temporomandibular joint (TMJ) or cervical region surgery in the last 3 months;
  • Treatment history from relevant areas;
  • Presence of rheumatic diseases, including TMJ diseases;
  • TMJ instability or fracture;
  • Presence of perception-cognition disorder;
  • Presence of chronic pain such as trigeminal neuralgia
  • Orthopedic, neurological or rheumatological cervical disorders affecting jaw movements
  • History of surgery in the jaw, head and neck area
  • Presence of vertigo that prevents head movements during exercise

Treatment and study plan

Rocabado's 6x6 Exercises

Other

Rocabado's 6x6 program includes 6 basic components: tongue rest position, TMJ rotation control, cervical spine release, shoulder girdle retraction and rhythmic stabilization technique.

PNF Exercises

Other

Proprioceptive neuromuscular facilitation (PNF) exercises will be applied to the neck and jaw with rhythmic stabilization (RS) and combined isotonic contraction (CIC) techniques. The RS protocol consists of alternating isometric contractions for 10 seconds and does not involve movement. The KIK technique involves combined concentric, isometric and eccentric contraction of the agonist muscle without rest, with each contraction lasting 5 seconds. KIK exercises consist of 5-15 repetitions per set, depending on the individual's tolerance. Between sets, a 30-second rest will be included. First, the RS protocol will be applied and after a 2-minute rest interval, the exercise will continue with the KIK protocol applications. The expected duration of exercise exercises is 30 minutes. Maximum performance will be requested from the individual in all repetitions and the necessary verbal commands will be given for appropriate movement.

Primary outcomes

  1. Jaw Range of Motion (PMO)

    Time frame: 8 weeks

    Painless mouth opening (PMO) is a test in which the individual's maximum capacity to open her/his mouth without pain is measured in cm with a ruler.

  2. Jaw Range of Motion (MMO)

    Time frame: 8 weeks

    Maximum mouth opening (MMO) is an outcome measure measured in cm in which the person opens their mouth to the maximum extent they can.

  3. Jaw Range of Motion (MAMO)

    Time frame: 8 weeks

    Maximum assisted mouth opening (MAMO) is the maximum amount of opening that a person's mouth is forced to open with the help of the hand.

  4. Pain Intensity

    Time frame: 8 weeks

    The person will be asked to mark the degree of pain he/she feels around the jaw on a ruler divided from 0 to 10 at equal intervals. According to VAS, 0 means "no pain" and 10 means "pain as bad as possible."

Secondary outcomes

  1. Pressure Pain Threshold

    Time frame: 8 weeks

    Pressure pain threshold is measured by the physiotherapist with a hand algometer (TMD/RDC) in the examination form, including M. Temporalis (posterior, middle, anterior parts), M. Masseter (origo, body, insertion), posterior mandibular region and under the mandible, and M. sternocleidomastoideus and It will be measured on M. trapezius. The algometer will be applied vertically to the most painful point, increasing the pressure by 1kg/cm2 every three seconds until the patient feels pain, and the pressure value at which the pain begins will be recorded. 3 measurements will be made at 60-second intervals and the average value will be accepted as the pain threshold.

  2. Functionality

    Time frame: 8 weeks

    The 8-item jaw functional limitation scale (JFLS-8) will be used to assess functionality. Each participant will be asked to report the level of restriction he or she has experienced for each of the eight items on the scale in the past month. Individuals will be told that the number "0" on the 10 cm horizontal line is no restriction and the number "10" is "severe restriction." Limitations in functionality will be determined by averaging each participant's responses.

  3. Mandibular Functionality

    Time frame: 8 weeks

    The MFIQ is designed to assess the patient's perception of mandibular dysfunction. It consists of 17 items and a 5-point Likert scale is presented for each item. On this scale, the patient can indicate how much difficulty he or she has performing a particular mandibular movement or task. Likert scale scores; 0, no difficulty; 1, some difficulty; 3, very difficult; 4 means very difficult or impossible without help. The MFIQ also consists of a scoring range from 0 to 68. Here 0 indicates no mandibular dysfunction.

Sponsors and collaborators

Lead sponsor

Istanbul Medipol University Hospital

Other

Registry information

Official study title

Investigation of the Effectiveness of Proprioceptive Neuromuscular Facilitation Exercises in Individuals With Temporomandibular Dysfunction With Forward Head Posture

Important dates

Study start
2023
Primary completion
2023
Study completion
2024
First posted
Oct 17, 2023
Registry last updated
Feb 20, 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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