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Is PNF Application Effective on Temporomandibular Dysfunction

Primary Purpose

TMD, TMJ Disorder, Pain

Status
Enrolling by invitation
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Rocabado's 6x6 Exercises
PNF Exercises
Sponsored by
Istanbul Medipol University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for TMD

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Gizem Ergezen

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Group 1

Group 2

Arm Description

Rocabado's 6 x 6 exercise program has been found to be beneficial in reducing pain and increasing masticatory muscle function, as well as improving forward head posture, correcting limited joint mobility, muscle length limitation, and postural and functional limitations. Rocabado's 6x6 program includes 6 basic components: tongue rest position, TMJ rotation control, cervical spine release, shoulder girdle retraction and rhythmic stabilization technique. Rocabado's 6x6 exercises will be shown to both groups and 6 sets and 6 repetitions will be performed per day for 8 weeks

Addition to Rocabado's, Proprioceptive neuromuscular facilitation (PNF) exercises will be applied to the neck and jaw with rhythmic stabilization (RS) and combined isotonic contraction (CIC) techniques. The patient will be placed supine on the treatment bed and asked to relax. The therapist's hands were placed according to PNF principles, depending on the applied technique and diagonality. Maximum resistance was provided to suit the needs of each individual 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.

Outcomes

Primary Outcome Measures

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.
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.
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.
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."

Secondary Outcome Measures

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.
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.
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.

Full Information

First Posted
October 11, 2023
Last Updated
October 11, 2023
Sponsor
Istanbul Medipol University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT06087432
Brief Title
Is PNF Application Effective on Temporomandibular Dysfunction
Official Title
Investigating the Effectiveness of Proprioceptive Neuromuscular Facilitation Exercises in Temporomandibular Dysfunction
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
September 5, 2023 (Actual)
Primary Completion Date
November 5, 2023 (Anticipated)
Study Completion Date
November 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul Medipol University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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 temporomandibular dysfunction (TMD). 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.
Detailed Description
Infrared heat will be applied to the neck and face areas for 15 minutes for individuals with TMD 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
TMD, TMJ Disorder, Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group 1
Arm Type
Active Comparator
Arm Description
Rocabado's 6 x 6 exercise program has been found to be beneficial in reducing pain and increasing masticatory muscle function, as well as improving forward head posture, correcting limited joint mobility, muscle length limitation, and postural and functional limitations. Rocabado's 6x6 program includes 6 basic components: tongue rest position, TMJ rotation control, cervical spine release, shoulder girdle retraction and rhythmic stabilization technique. Rocabado's 6x6 exercises will be shown to both groups and 6 sets and 6 repetitions will be performed per day for 8 weeks
Arm Title
Group 2
Arm Type
Experimental
Arm Description
Addition to Rocabado's, Proprioceptive neuromuscular facilitation (PNF) exercises will be applied to the neck and jaw with rhythmic stabilization (RS) and combined isotonic contraction (CIC) techniques. The patient will be placed supine on the treatment bed and asked to relax. The therapist's hands were placed according to PNF principles, depending on the applied technique and diagonality. Maximum resistance was provided to suit the needs of each individual 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.
Intervention Type
Other
Intervention Name(s)
Rocabado's 6x6 Exercises
Intervention Description
Rocabado's 6x6 program includes 6 basic components: tongue rest position, TMJ rotation control, cervical spine release, shoulder girdle retraction and rhythmic stabilization technique.
Intervention Type
Other
Intervention Name(s)
PNF Exercises
Intervention Description
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 Outcome Measure Information:
Title
Jaw Range of Motion (PMO)
Description
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.
Time Frame
8 weeks
Title
Jaw Range of Motion (MMO)
Description
Maximum mouth opening (MMO) is an outcome measure measured in cm in which the person opens their mouth to the maximum extent they can.
Time Frame
8 weeks
Title
Jaw Range of Motion (MAMO)
Description
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.
Time Frame
8 weeks
Title
Pain Intensity
Description
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."
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Pressure Pain Threshold
Description
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.
Time Frame
8 weeks
Title
Functionality
Description
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.
Time Frame
8 weeks
Title
Mandibular Functionality
Description
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.
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gizem Ergezen, PhD
Organizational Affiliation
Medipol University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Gizem Ergezen
City
Istanbul
State/Province
Beykoz
ZIP/Postal Code
34810
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
Yes

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Is PNF Application Effective on Temporomandibular Dysfunction

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