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CompletedNCT05778890Updated Mar 21, 2023

Home Exercises Program Compared With Physiotherapy Program in TMD

An interventional study of Intervention Group: Physiotherapy program + home exercises program and Control Group : Physiotherapy program in Temporomandibular Disorder, sponsored by Nigde Omer Halisdemir University. Completed at 1 site in Turkey. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-03-21.

Sponsored by Nigde Omer Halisdemir University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 5 years 7 months after the study started (first participant enrolled Jul 2017, registered Mar 2023).
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

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.
02

Conditions studied

  • Temporomandibular Disorder

Keywords

  • temporomandibular joint disorders
  • pain
  • quality of life
  • exercises
03

In context

Temporomandibular Joint Disorders

609 studies on the registry are indexed under Temporomandibular Joint Disorders; 160 are open to participants now.

This study's enrollment of 20 is below the median of 46 across 434 interventional studies indexed under Temporomandibular Joint Disorders.

Browse Temporomandibular Joint Disorders studies →

Lead sponsor

Nigde Omer Halisdemir University is the lead sponsor of 89 studies on the registry; 30 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Having a clinical and radiological diagnosis for TMD,
  • Age between 18-65
  • having TMJ pain for at least 3 months

Exclusion criteria

Exclusion Criteria:

  • 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).
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
20 participants (actual)

Study arms

  • Experimental
    Intervention group

    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.

    Other: Intervention Group: Physiotherapy program + home exercises program

  • Active comparator
    control group

    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.

    Other: Control Group : Physiotherapy program

Interventions

  • OtherIntervention Group: Physiotherapy program + home exercises program

    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.

  • OtherControl Group : Physiotherapy program

    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.

06

What researchers measure

Primary outcomes

  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.

    Time frame: 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.

    Time frame: 3 weeks

07

Study locations

1 site
  • Niğde Ömer Halisdemir University Bor Physical Therapy Hospital
    Niğde, 51100, Turkey
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 21, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05778890
Lead sponsor
Nigde Omer Halisdemir University
Responsible party
Gül PEHLİVAN TEKİN (Lecturer, Nigde Omer Halisdemir University) — Principal investigator
First posted
Mar 21, 2023
Start date
Jul 10, 2017
Primary completion
Feb 20, 2018
Completion
May 2, 2018
Last update
Mar 21, 2023

Study contacts

Gül PEHLİVAN TEKİN
study director · Niğde Bor Physical Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.

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