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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).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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

Other trials in Turkey (Türkiye)

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:

  1. 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.
  2. Shoulder posture: The shoulders are moved downwards and backwards at the same time to bring the shoulder blades closer together.
  3. 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)
  4. 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).
  5. 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.
  6. 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.
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 groups in NCT05778890
Study groupRoleWhat they receive
Intervention groupExperimentalThe 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 groupActive comparatorControl 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.

  1. 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)
  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.

  1. First posted21 Mar 2023
  2. Study start10 Jul 2017
  3. Primary completion20 Feb 2018
  4. Study completion2 May 2018

Resources

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)
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

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.

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