Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05778890 |
| Other study ID # |
Nigdeohu-ZHMYO-GPT-01 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
July 10, 2017 |
| Est. completion date |
May 2, 2018 |
Study information
| Verified date |
March 2023 |
| Source |
Nigde Omer Halisdemir University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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.
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.
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.
