Temporomandibular Joint DisordersNCT05709340
PNF Exercises on Treatment of Temporomandibular Dysfunction
A study testing proprioceptive neuromuscular facilitation exercises and traditional physical therapy treatment in people with Temporomandibular Joint Disorders, run by Cairo University at 1 site in Egypt.
Trial summary
Temporomandibular joint dysfunction (TMJD) is an important health problem that occurs approximately in 22 to 35 percent of adults, different physiotherapy methods are reported as treatment options for management of TMJD. Read more about this study
- Who is it for?
- Ages 20 to 40 years
- Conditions the study is for
- Temporomandibular Joint Disorders
- What is being tested?
- proprioceptive neuromuscular facilitation exercises and traditional physical therapy treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteEgypt
- Study dates
- 25 Jan 2023to 15 Apr 2023
- 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 20 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients of both genders of age between 20-40 years
- having symptoms of TMD for at least six weeks duration established by an expert physician or orthopaedician
- having forward head posture with CVA < 53
- pain over TMJ between 3 to 6 on NPRS
- mouth opening < 25mm.
Who cannot join
- Patients will be excluded if they exhibited any of the following criteria:
- TMJ fracture undergone any surgical procedure for TMJ
- Fracture surrounding TMJ
- Dislocation or subluxation of TMJ
- systemic generalized joint diseases, such as rheumatoid arthritis, and osteoporosis, congenital diseases, or facial paralysis
- recently any dental treatment is taken or surgery over TMJ
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- hematological cervical disorders which may affect the jaw
- Neurological deficits e.g. Bells palsy, Trigeminal neuralgia.
- Recent infections (within the last six months) affecting the head and neck e.g. bone infections, meningitis, encephalitis, malaria, ear infection
- Participants who were using any functional appliances e.g. dentures, braces, bite appliances which had been adjusted or fitted in the last 12 weeks prior to the commencement of this study
- DDwR, DDwoR
- Patients were excluded from the study if they were receiving any other form of treatment for their TMJ dysfunction.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of PNF Exercises on Treatment of Temporomandibular Dysfunction in Patients With Forward Head Posture: A Double-blind, Randomized, Controlled Trial
Temporomandibular joint dysfunction (TMJD) is an important health problem that occurs approximately in 22 to 35 percent of adults, different physiotherapy methods are reported as treatment options for management of TMJD. Although that, there is no previous studies about the efficacy of PNF exercises in treatment of TMJD in patients with forward head posture. So, the purpose of the present double-blind, randomized, controlled trial is to investigate the efficacy of PNF exercises in treatment of TMJD in patients with forward head posture.
- Conditions
- Temporomandibular Joint Disorders
- Being tested
- proprioceptive neuromuscular facilitation exercises, traditional physical therapy treatment
- Medical subject headings
- Temporomandibular Joint Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
proprioceptive neuromuscular facilitation exercisesOther
PNF exercises will be done for Masseter, Temporalis, Lateral pterygoid and medial pterygoid muscles. Each contraction will be held for 10 seconds, and each stretch (relaxation phase) will be allowed to continue as long as the muscle tension continued to give away.
traditional physical therapy treatmentOther
- Ultrasound: Continuous ultrasound at 1MHZ to temporomandibular joint at 1.0-1.25 W/CM2 for 5 min over each affected TMJ and masseter area, with the mouth in a slightly open position.
- Forward head posture correction exercises including: chin tuck exercise, Strengthening shoulder retractors, stretching of sternocleidomastoid muscle, and Stretching of pectoralis muscle.
| Study group | Role | What they receive |
|---|---|---|
| study group | Experimental | Not described Receives: Other: proprioceptive neuromuscular facilitation exercises |
| control group | Active comparator | Not described Receives: Other: traditional physical therapy treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pressure Pain Threshold
A pressure algometer will be used for the objective measurement of the PPT. The algometer was pressed on the masseter, temporalis muscles until the patient feel pain. The unit of measurement will be in kg/cm2, and three measurements will be taken every 30 seconds. The average of the three consecutive measurements will be taken as the final value.
Measured: change from base line at 6 weeks.
Secondary outcomes (3)
ROM assessment
A caliper will be used to measure mandibular depression, protrusion and lateral deviation.
Measured: change from base line at 6 weeks.
Temporomandibular Disorder Disability Questionnaire
This questionnaire consists of the following:
- The Temporomandibular Disorder Disability Index. It consists of 10 questions with 5 possible answers, rating a 0 to 4 score level for each of the answers.
- The Temporomandibular Disorder symptom intensity scale and the Temporomandibular Disorder symptom frequency scale are two visual analogue scales which address the frequency and intensity of a patient's TMJ symptoms and consist of 7 sections for each scale where the patient must rate his/her intensity and frequency of symptoms on a scale of 0 to 10 score level.
- The Pain Drawing sheet is used by the patients to capture pain location and quality.
Measured: change from base line at 6 weeks.
Numerical Rating Scale (NRS)
The patient will be asked to indicate a number between 0 and 100 on a horizontal line, that best described his/her perceived level of pain intensity when it is at its worst and when it is at is least. The average of these two totals indicates the average pain experienced by the patient as a percentage.
Measured: change from baseline at 6 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2023
- Study start25 Jan 2023
- Primary completion25 Mar 2023
- Study completion15 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Temporomandibular Joint DisordersStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marwa Shafiek Mustafa Saleh, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05709340
- Sponsor's protocol ID
- PNF exercises for TMJ
- Status last verified
- Apr 2023
- First submitted
- 21 Jan 2023
- Last updated
- 18 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of PNF Exercises on Treatment of Temporomandibular Dysfunction in Patients With Forward Head Posture: A Double-blind, Randomized, Controlled Trial
- ClinicalTrials.gov ID
- NCT05709340
- Acronym / sponsor ID
- PNF exercises for TMJ
- Conditions
- Temporomandibular Joint Disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 25 Jan 2023 (actual)
- Primary completion
- 25 Mar 2023 (actual)
- Study completion
- 15 Apr 2023 (actual)
- First posted
- 2 Feb 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.
Temporomandibular joint dysfunction (TMJD) is an important health problem that occurs approximately in 22 to 35 percent of adults, different physiotherapy methods are reported as treatment options for management of TMJD. Although that, there is no previous studies about the efficacy of PNF exercises in treatment of TMJD in patients with forward head posture. So, the purpose of the present double-blind, randomized, controlled trial is to investigate the efficacy of PNF exercises in treatment of TMJD in patients with forward head posture.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| study group | Experimental | Other: proprioceptive neuromuscular facilitation exercises |
| control group | Active comparator | Other: traditional physical therapy treatment |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Patients of both genders of age between 20-40 years
- having symptoms of TMD for at least six weeks duration established by an expert physician or orthopaedician
- having forward head posture with CVA < 53
- pain over TMJ between 3 to 6 on NPRS
- mouth opening < 25mm.
Key exclusion criteria (12 listed)
- TMJ fracture undergone any surgical procedure for TMJ
- Fracture surrounding TMJ
- Dislocation or subluxation of TMJ
- systemic generalized joint diseases, such as rheumatoid arthritis, and osteoporosis, congenital diseases, or facial paralysis
- recently any dental treatment is taken or surgery over TMJ
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 |
|---|---|---|
| proprioceptive neuromuscular facilitation exercisesPNF exercises will be done for Masseter, Temporalis, Lateral pterygoid and medial pterygoid muscles. Each contraction will be held for 10 seconds, and each stretch (relaxation phase) will be allowed to continue as long as the muscle tension continued to give away. | Other | study group |
| traditional physical therapy treatment* Ultrasound: Continuous ultrasound at 1MHZ to temporomandibular joint at 1.0-1.25 W/CM2 for 5 min over each affected TMJ and masseter area, with the mouth in a slightly open position. * Forward head posture correction exercises including: chin tuck exercise, Strengthening shoulder retractors, stretching of sternocleidomastoid muscle, and Stretching of pectoralis muscle. | Other | control group |
Primary outcome
Pressure Pain Threshold
Time frame: change from base line at 6 weeks.
A pressure algometer will be used for the objective measurement of the PPT. The algometer was pressed on the masseter, temporalis muscles until the patient feel pain. The unit of measurement will be in kg/cm2, and three measurements will be taken every 30 seconds. The average of the three consecutive measurements will be taken as the final value.
3 secondary outcomes
ROM assessment
Time frame: change from base line at 6 weeks.
Temporomandibular Disorder Disability Questionnaire
Time frame: change from base line at 6 weeks.
Numerical Rating Scale (NRS)
Time frame: change from baseline at 6 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 18 Apr 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing proprioceptive neuromuscular facilitation exercises and traditional physical therapy treatment in people with Temporomandibular Joint Disorders, run by Cairo University at 1 site in Egypt.
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 5 inclusion and 12 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 18 Apr 2023. 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 Egypt. 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?
Pressure Pain Threshold (time frame: change from base line at 6 weeks.). 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 18 Apr 2023.