Is PNF Application Effective on Temporomandibular Dysfunction

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06087432
• Other study ID #: E-10840098-772.02-7705
• Status: Enrolling by invitation
• Phase: N/A
• Start date: September 5, 2023
• Est. completion date: November 30, 2023

Study information

• Verified date: November 2023
• Source: Istanbul Medipol University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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).

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 40
• Est. completion date: November 30, 2023
• Est. primary completion date: November 5, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain
• Temporomandibular Joint Disorders
• Temporomandibular Joint Dysfunction Syndrome
• TMD
• TMJ Disorder

Intervention

Other:
• Rocabado's 6x6 Exercises
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
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.

Locations

Country	Name	City	State
Turkey	Gizem Ergezen	Istanbul	Beykoz

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul Medipol University Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Jaw Range of Motion (PMO)	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.	8 weeks
Primary	Jaw Range of Motion (MMO)	Maximum mouth opening (MMO) is an outcome measure measured in cm in which the person opens their mouth to the maximum extent they can.	8 weeks
Primary	Jaw Range of Motion (MAMO)	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.	8 weeks
Primary	Pain Intensity	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."	8 weeks
Secondary	Pressure Pain Threshold	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.	8 weeks
Secondary	Functionality	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.	8 weeks
Secondary	Mandibular Functionality	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.	8 weeks