Temporomandibular DisorderNCT05778890
Home Exercises Program Compared With Physiotherapy Program in TMD
A study testing Intervention Group: Physiotherapy program + home exercises program in people with Temporomandibular Disorder, run by Nigde Omer Halisdemir University at 1 site in Turkey (Türkiye).
Trial summary
Introduction: Although there are physiotherapy programs that are widely used in the treatment of Temporomandibular Disorders (TMD), there are few studies investigating the effects of home exercises program specifically developed for TMD. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Temporomandibular Disorder
- What is being tested?
- Intervention Group: Physiotherapy program + home exercises program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Jul 2017to 2 May 2018
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Having a clinical and radiological diagnosis for TMD,
- Age between 18-65
- having TMJ pain for at least 3 months
Who cannot join
- Having an inflammatory connective tissue disease such as rheumatoid arthritis,
- Malignant tumor involving the craniocervical region,
- Heart conditions or using a pacemaker,
- Pregnancy
- Receiving any treatment for TMJ within the last 2 years (including surgery, orthotics, physical therapy).
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Niğde Ömer Halisdemir University Bor Physical Therapy Hospital
Niğde, 51100
About this study
Official title: The Investigation of Effects Different Physiotherapy Methods on Pain and Quality of Life in Patients With Temporomandibular Joint Disorders: A Pilot Study
Introduction: Although there are physiotherapy programs that are widely used in the treatment of Temporomandibular Disorders (TMD), there are few studies investigating the effects of home exercises program specifically developed for TMD.
Aim: Investigators aimed to investigate the effect of home exercise program on pain and quality of life in TMD treatment.
Methods: 20 patients were included in our pilot study and were randomised into two groups. Home exercises program and physiotherapy program were applied to the intervention group (n=10; age 31.4±11.2 years), and only physiotherapy program to the control group (n=10, age 35.3±18.1 years). Physiotherapy program included ultrasound (US), Transcutaneous Electrical Nerve Stimulation (TENS) and exercise. Investigators measured pain with the Visual Analogue Scale (VAS) and quality of life with the Short Form 36 (SF-36) before and after the treatment.
Read the detailed description
This study was carried out on 20 patients who applied to Nigde Omer Halisdemir University Bor Physical Therapy and Rehabilitation Hospital and were diagnosed with TMD. Twenty patients were divided into two groups of ten each with randomisation (closed envelope method). Bilateral TMD were diagnosed according to the Research Diagnostic Criteria for TMD used by Department of Physical Medicine and Rehabilitation in Nigde Omer Halisdemir University Bor Physical Therapy and Rehabilitation Hospital . Ethical approval for the study was obtained from Nigde Omer Halisdemir University Bor Physical Therapy and Rehabilitation Hospital (63524359-915.03.03) and Nigde Omer Halisdemir University Ethics Committee (2017/10-05). All participants were given an informed consent form before the study.
Visual Analogue Scale (VAS) for pain and SF-36 Quality of Life Questionnaire for quality of life were used as main outcome measurements. It was questioned whether each patient had pain in the head, neck, shoulder, lower back, jaw, teeth and back for the last 6 and the patients were asked to mark the severity of the existing pain on a 10 cm chart weeks (0=no pain, 10= worst imaginable pain). Then, these points were evaluated by measuring with a ruler (12). The SF-36 Quality of Life Questionnaire is a patient reported outcome measurement with 8 sub-parameters, consisting of 36 items to obtain information about the health status of a person. These parameters are vitality, physical function, pain, general health, physical role difficulty, emotional function, social function and mental health. SF-36 total score ranges between 0-100, 0 means poor health while 100 means no health problem (13). Pain and quality of life were assessed before (BT) and after the treatment (AT).
Treatment The physiotherapy program consisted of 1 session per day for 3 weeks, a total of 15 sessions. Treatment for control group included Ultrasound for 5 minutes to both TMJ, TENS on both TMJ for 20 minutes, exercise for 30 minutes and patient education. In addition to the treatment for control group, intervention group received home exercises program.
Ultrasound (Chattanooga Intellect Mobile Ultrasound) was applied for 5 minutes at a dose of 1.5 watts/cm² with circular movements. Transcutaneous electrical stimulation (BTL-4000) was applied at a frequency of 100 Hz and at the current intensity that the patient clearly felt for 20 minutes. As exercise, Temporomandibular joint isotonic and isometric strengthening, posture, stretching and relaxation, and breathing exercises were taught to both groups. During the treatment period, the patients performed the exercises under the supervision of a physiotherapist after the US and TENS application.
The intervention group was also taught home exercises program and asked to do 6 repetitions 6 times a day. This exercise program was given to the patients in brochure form. These exercises were not given to the control group.
Patient education was given to each patient by explaining the parafunctional habits and methods that they could apply in their daily life to reduce the pain, and a brochure containing this information was distributed.
Rocabado's 6x6 Exercises:
- Tongue relaxation position: When the teeth are slightly open and the lips are closed, 1/3 of the tongue applies gentle pressure to the palate. The tongue should never touch the teeth. Breathe through the nose using the diaphragm.
- Shoulder posture: The shoulders are moved downwards and backwards at the same time to bring the shoulder blades closer together.
- Fixing the position of the head: To fix the neck, the hands are clasped behind the neck and the head is moved forward and upward. (Distraction movement)
- Movement of the jaw joint: It is the movement of the jaw closer to the neck and away (anterior-posterior gliding to the cervical spines).
- Control of TMJ rotation: When the tongue is in the relaxation position, the index finger is placed on the TMJ and mouth opening and closing movements are performed. It prevents the jaw from sliding left and right. In this way, controlled chewing is taught to the patient.
- Rhythmic stabilization technique: While the tongue is in the relaxation position, the index fingers are placed on the TMJ and the chin is fixed. The patient is asked to apply a slight resistance and the movements of TMJ opening, closing, shifting to the right and left (lateral deviations) are taught.
- Conditions
- Temporomandibular Disorder
- Being tested
- Intervention Group: Physiotherapy program + home exercises program, Control Group : Physiotherapy program
- Keywords
- temporomandibular joint disorders, pain, quality of life, exercises
- Medical subject headings
- Temporomandibular Joint Disorders, Pain, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention Group: Physiotherapy program + home exercises programOther
Physiotherapy program: The physiotherapy program consisted of 1 session per day for 3 weeks, a total of 15 sessions. Treatment for control group included Ultrasound for 5 minutes to both TMJ, TENS on both TMJ for 20 minutes, exercise for 30 minutes and patient education. In addition to the treatment for control group, intervention group received home exercises program.The intervention group was also taught home exercises program and asked to do 6 repetitions 6 times a day. This exercise program was given to the patients in brochure form.
Control Group : Physiotherapy programOther
Physiotherapy program: The physiotherapy program consisted of 1 session per day for 3 weeks, a total of 15 sessions. Treatment for control group included Ultrasound for 5 minutes to both TMJ, TENS on both TMJ for 20 minutes, exercise for 30 minutes and patient education.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | The physiotherapy program consisted of 1 session per day for 3 weeks, a total of 15 sessions. Intervention group included Ultrasound for 5 minutes to both TMJ, TENS on both TMJ for 20 minutes, exercise for 30 minutes and patient education. The intervention group was also taught home exercises program and asked to do 6 repetitions 6 times a day. This exercise program was given to the patients in brochure form. These exercises were not given to the control group. Receives: Other: Intervention Group: Physiotherapy program + home exercises program |
| control group | Active comparator | Control group is physiotherapy program consisted of 1 session per day for 3 weeks, a total of 15 sessions. This group included Ultrasound for 5 minutes to both TMJ, TENS on both TMJ for 20 minutes, exercise for 30 minutes and patient education. Receives: Other: Control Group : Physiotherapy program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain. Visual Analogue Scale (VAS)
It was questioned whether each patient had pain in the head, neck, shoulder, lower back, jaw, teeth and back for the last 6 and the patients were asked to mark the severity of the existing pain on a 10 cm chart weeks (0=no pain, 10= worst imaginable pain). Then, these points were evaluated by measuring with a ruler.
Measured: 3 weeks
Secondary outcomes (1)
Quality of Life. SF-36 Quality of Life Questionnaire
The SF-36 Quality of Life Questionnaire is a patient reported outcome measurement with 8 sub-parameters, consisting of 36 items to obtain information about the health status of a person. These parameters are vitality, physical function, pain, general health, physical role difficulty, emotional function, social function and mental health. SF-36 total score ranges between 0-100, 0 means poor health while 100 means no health problem.
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2023
- Study start10 Jul 2017
- Primary completion20 Feb 2018
- Study completion2 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Temporomandibular DisorderStudies 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
- Model description
- 20 patients were included in our pilot study and were randomised into two groups. Traditional physiotherapy program and home exercises program were applied to the intervention group (n=10; age 31.4±11.2 years), and only traditional physiotherapy to the control group (n=10, age 35.3±18.1 years). Traditional physiotherapy program included ultrasound (US), TENS and exercise.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nigde Omer Halisdemir University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gül PEHLİVAN TEKİN, Nigde Omer Halisdemir University
- Investigators
- Gül PEHLİVAN TEKİN, Study director, Niğde Bor Physical Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05778890
- Sponsor's protocol ID
- Nigdeohu-ZHMYO-GPT-01
- Status last verified
- Mar 2023
- First submitted
- 6 Mar 2023
- Last updated
- 21 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Investigation of Effects Different Physiotherapy Methods on Pain and Quality of Life in Patients With Temporomandibular Joint Disorders: A Pilot Study
- ClinicalTrials.gov ID
- NCT05778890
- Acronym / sponsor ID
- Nigdeohu-ZHMYO-GPT-01
- Conditions
- Temporomandibular Disorder
- Keywords
- temporomandibular joint disorders, pain, quality of life, exercises
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Nigde Omer Halisdemir UniversityUniversity, hospital or other
- Study start
- 10 Jul 2017 (actual)
- Primary completion
- 20 Feb 2018 (actual)
- Study completion
- 2 May 2018 (actual)
- First posted
- 21 Mar 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.
Introduction: Although there are physiotherapy programs that are widely used in the treatment of Temporomandibular Disorders (TMD), there are few studies investigating the effects of home exercises program specifically developed for TMD.
Aim: Investigators aimed to investigate the effect of home exercise program on pain and quality of life in TMD treatment.
Methods: 20 patients were included in our pilot study and were randomised into two groups. Home exercises program and physiotherapy program were applied to the intervention group (n=10; age 31.4±11.2 years), and only physiotherapy program to the control group (n=10, age 35.3±18.1 years). Physiotherapy program included ultrasound (US), Transcutaneous Electrical Nerve Stimulation (TENS) and exercise. Investigators measured pain with the Visual Analogue Scale (VAS) and quality of life with the Short Form 36 (SF-36) before and after the treatment.
Detailed description
This study was carried out on 20 patients who applied to Nigde Omer Halisdemir University Bor Physical Therapy and Rehabilitation Hospital and were diagnosed with TMD. Twenty patients were divided into two groups of ten each with randomisation (closed envelope method). Bilateral TMD were diagnosed according to the Research Diagnostic Criteria for TMD used by Department of Physical Medicine and Rehabilitation in Nigde Omer Halisdemir University Bor Physical Therapy and Rehabilitation Hospital . Ethical approval for the study was obtained from Nigde Omer Halisdemir University Bor Physical Therapy and Rehabilitation Hospital (63524359-915.03.03) and Nigde Omer Halisdemir University Ethics Committee (2017/10-05). All participants were given an informed consent form before the study.
Visual Analogue Scale (VAS) for pain and SF-36 Quality of Life Questionnaire for quality of life were used as main outcome measurements. It was questioned whether each patient had pain in the head, neck, shoulder, lower back, jaw, teeth and back for the last 6 and the patients were asked to mark the severity of the existing pain on a 10 cm chart weeks (0=no pain, 10= worst imaginable pain). Then, these points were evaluated by measuring with a ruler (12). The SF-36 Quality of Life Questionnaire is a patient reported outcome measurement with 8 sub-parameters, consisting of 36 items to obtain information about the health status of a person. These parameters are vitality, physical function, pain, general health, physical role difficulty, emotional function, social function and mental health. SF-36 total score ranges between 0-100, 0 means poor health while 100 means no health problem (13). Pain and quality of life were assessed before (BT) and after the treatment (AT).
Treatment The physiotherapy program consisted of 1 session per day for 3 weeks, a total of 15 sessions. Treatment for control group included Ultrasound for 5 minutes to both TMJ, TENS on both TMJ for 20 minutes, exercise for 30 minutes and patient education. In addition to the treatment for control group, intervention group received home exercises program.
Ultrasound (Chattanooga Intellect Mobile Ultrasound) was applied for 5 minutes at a dose of 1.5 watts/cm² with circular movements. Transcutaneous electrical stimulation (BTL-4000) was applied at a frequency of 100 Hz and at the current intensity that the patient clearly felt for 20 minutes. As exercise, Temporomandibular joint isotonic and isometric strengthening, posture, stretching and relaxation, and breathing exercises were taught to both groups. During the treatment period, the patients performed the exercises under the supervision of a physiotherapist after the US and TENS application.
The intervention group was also taught home exercises program and asked to do 6 repetitions 6 times a day. This exercise program was given to the patients in brochure form. These exercises were not given to the control group.
Patient education was given to each patient by explaining the parafunctional habits and methods that they could apply in their daily life to reduce the pain, and a brochure containing this information was distributed.
Rocabado's 6x6 Exercises:
- Tongue relaxation position: When the teeth are slightly open and the lips are closed, 1/3 of the tongue applies gentle pressure to the palate. The tongue should never touch the teeth. Breathe through the nose using the diaphragm.
- Shoulder posture: The shoulders are moved downwards and backwards at the same time to bring the shoulder blades closer together.
- Fixing the position of the head: To fix the neck, the hands are clasped behind the neck and the head is moved forward and upward. (Distraction movement)
- Movement of the jaw joint: It is the movement of the jaw closer to the neck and away (anterior-posterior gliding to the cervical spines).
- Control of TMJ rotation: When the tongue is in the relaxation position, the index finger is placed on the TMJ and mouth opening and closing movements are performed. It prevents the jaw from sliding left and right. In this way, controlled chewing is taught to the patient.
- Rhythmic stabilization technique: While the tongue is in the relaxation position, the index fingers are placed on the TMJ and the chin is fixed. The patient is asked to apply a slight resistance and the movements of TMJ opening, closing, shifting to the right and left (lateral deviations) are taught.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- 20 patients were included in our pilot study and were randomised into two groups. Traditional physiotherapy program and home exercises program were applied to the intervention group (n=10; age 31.4±11.2 years), and only traditional physiotherapy to the control group (n=10, age 35.3±18.1 years). Traditional physiotherapy program included ultrasound (US), TENS and exercise.
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: Intervention Group: Physiotherapy program + home exercises programThe physiotherapy program consisted of 1 session per day for 3 weeks, a total of 15 sessions. Intervention group included Ultrasound for 5 minutes to both TMJ, TENS on both TMJ for 20 minutes, exercise for 30 minutes and patient education. The intervention group was also taught home exercises program and asked to do 6 repetitions 6 times a day. This exercise program was given to the patients in brochure form. These exercises were not given to the control group. |
| control group | Active comparator | Other: Control Group : Physiotherapy programControl group is physiotherapy program consisted of 1 session per day for 3 weeks, a total of 15 sessions. This group included Ultrasound for 5 minutes to both TMJ, TENS on both TMJ for 20 minutes, exercise for 30 minutes and patient education. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Having a clinical and radiological diagnosis for TMD,
- Age between 18-65
- having TMJ pain for at least 3 months
Key exclusion criteria (5 listed)
- Having an inflammatory connective tissue disease such as rheumatoid arthritis,
- Malignant tumor involving the craniocervical region,
- Heart conditions or using a pacemaker,
- Pregnancy
- Receiving any treatment for TMJ within the last 2 years (including surgery, orthotics, physical therapy).
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 |
|---|---|---|
| Intervention Group: Physiotherapy program + home exercises programPhysiotherapy program: The physiotherapy program consisted of 1 session per day for 3 weeks, a total of 15 sessions. Treatment for control group included Ultrasound for 5 minutes to both TMJ, TENS on both TMJ for 20 minutes, exercise for 30 minutes and patient education. In addition to the treatment for control group, intervention group received home exercises program.The intervention group was also taught home exercises program and asked to do 6 repetitions 6 times a day. This exercise program was given to the patients in brochure form. | Other | Intervention group |
| Control Group : Physiotherapy programPhysiotherapy program: The physiotherapy program consisted of 1 session per day for 3 weeks, a total of 15 sessions. Treatment for control group included Ultrasound for 5 minutes to both TMJ, TENS on both TMJ for 20 minutes, exercise for 30 minutes and patient education. | Other | control group |
Primary outcome
Pain. Visual Analogue Scale (VAS)
Time frame: 3 weeks
It was questioned whether each patient had pain in the head, neck, shoulder, lower back, jaw, teeth and back for the last 6 and the patients were asked to mark the severity of the existing pain on a 10 cm chart weeks (0=no pain, 10= worst imaginable pain). Then, these points were evaluated by measuring with a ruler.
1 secondary outcome
Quality of Life. SF-36 Quality of Life Questionnaire
Time frame: 3 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 21 Mar 2023.
- Individual participant dataSharing planned: No
Related trials for Temporomandibular Disorder
Recruiting
R01_Pilot Jaw Muscle Phenotypes
Chronic TMD Pain, Temporomandibular Disorder
Recruiting
Evaluation of the Effect of Adding Sodium Bicarbonate to Lidocaine in the Treatment of Myofascial Pain Syndrome
Myofacial Pain, Myofacial Pain Syndrome
Recruiting
Clinical and Electromyographic Assessment of Occlusal Splint Therapy
Temporomandibular Joint Disorders
Recruiting
An Open Label Study Assessing REN Treatment in Headache Management in Temporomandibular Disorders
Temporomandibular Disorder, Orofacial Pain
Enrolling by invitationObservational study
Long-term Safety and Performance of Materialise's Patient-specific TMJ System.
Temporomandibular Joint Disorders
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.
Gül PEHLİVAN TEKİN study director
Niğde Bor Physical Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention Group: Physiotherapy program + home exercises program in people with Temporomandibular Disorder, run by Nigde Omer Halisdemir University 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 5 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 21 Mar 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 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?
Pain. Visual Analogue Scale (VAS) (time frame: 3 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 21 Mar 2023.