TMDNCT06087432
Is PNF Application Effective on Temporomandibular Dysfunction
A study testing Rocabado's 6x6 Exercises and PNF Exercises in people with TMD and TMJ Disorder, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- TMD, TMJ Disorder, Pain
- What is being tested?
- Rocabado's 6x6 Exercises and PNF Exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Sep 2023to 30 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Diagnosis of TMD according to the diagnostic criteria for temporomandibular disorders (RDC/TMD),
- Presence of trigger points in the relevant muscles,
- Presence of pain
Who cannot join
- 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;
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation of the Effectiveness of Proprioceptive Neuromuscular Facilitation Exercises in Individuals With Temporomandibular Dysfunction With Forward Head Posture
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.
Read the detailed 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).
- Conditions
- TMD, TMJ Disorder, Pain
- Being tested
- Rocabado's 6x6 Exercises, PNF Exercises
- Medical subject headings
- Temporomandibular Joint Disorders, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rocabado's 6x6 ExercisesOther
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 ExercisesOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Active comparator | 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 Receives: Other: Rocabado's 6x6 Exercises |
| Group 2 | Experimental | 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. Receives: Other: Rocabado's 6x6 Exercises; Other: PNF Exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 8 weeks
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.
Measured: 8 weeks
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.
Measured: 8 weeks
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."
Measured: 8 weeks
Secondary outcomes (3)
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.
Measured: 8 weeks
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.
Measured: 8 weeks
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.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2023
- Study start5 Sep 2023
- Primary completion5 Nov 2023
- Study completion30 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TMDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Medipol University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, gizem ergezen, Istanbul Medipol University Hospital
- Investigators
- Gizem Ergezen, PhD, Principal investigator, Medipol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06087432
- Sponsor's protocol ID
- E-10840098-772.02-7705
- Status last verified
- Nov 2023
- First submitted
- 11 Oct 2023
- Last updated
- 20 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effectiveness of Proprioceptive Neuromuscular Facilitation Exercises in Individuals With Temporomandibular Dysfunction With Forward Head Posture
- ClinicalTrials.gov ID
- NCT06087432
- Acronym / sponsor ID
- E-10840098-772.02-7705
- Conditions
- TMD, TMJ Disorder, Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Istanbul Medipol University HospitalUniversity, hospital or other
- Study start
- 5 Sep 2023 (actual)
- Primary completion
- 5 Nov 2023 (actual)
- Study completion
- 30 Dec 2024 (actual)
- First posted
- 17 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Active comparator | Other: Rocabado's 6x6 ExercisesRocabado'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 |
| Group 2 | Experimental | Other: Rocabado's 6x6 Exercises, Other: PNF ExercisesAddition 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Diagnosis of TMD according to the diagnostic criteria for temporomandibular disorders (RDC/TMD),
- Presence of trigger points in the relevant muscles,
- Presence of pain
Key exclusion criteria (10 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rocabado's 6x6 ExercisesRocabado's 6x6 program includes 6 basic components: tongue rest position, TMJ rotation control, cervical spine release, shoulder girdle retraction and rhythmic stabilization technique. | Other | Group 1, Group 2 |
| PNF ExercisesProprioceptive 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. | Other | Group 2 |
Primary outcome
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.
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.
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.
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."
3 secondary outcomes
Pressure Pain Threshold
Time frame: 8 weeks
Functionality
Time frame: 8 weeks
Mandibular Functionality
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2025.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gizem Ergezen, PhD principal investigator
Medipol University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rocabado's 6x6 Exercises and PNF Exercises in people with TMD and TMJ Disorder, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Jaw Range of Motion (PMO) (time frame: 8 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2025.