Home Exercises Program Compared With Physiotherapy Program in TMD

Sponsor
Nigde Omer Halisdemir University (Other)
Overall Status
Completed
CT.gov ID
NCT05778890
Collaborator
(none)
20
1
2
9.7
2.1

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Other: Intervention Group: Physiotherapy program + home exercises program
  • Other: Control Group : Physiotherapy program
N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
20 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention 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.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 (Participant, Outcomes Assessor)
Masking Description:
Twenty patients were divided into two groups of ten each with randomisation (closed envelope method). outcomes assessor was blinded to group allocation.
Primary Purpose:
Treatment
Official Title:
The Investigation of Effects Different Physiotherapy Methods on Pain and Quality of Life in Patients With Temporomandibular Joint Disorders: A Pilot Study
Actual Study Start Date :
Jul 10, 2017
Actual Primary Completion Date :
Feb 20, 2018
Actual Study Completion Date :
May 2, 2018

Arms and Interventions

Arm Intervention/Treatment
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
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.

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
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.

Outcome Measures

Primary Outcome Measures

  1. Pain. Visual Analogue Scale (VAS) [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.

Secondary Outcome Measures

  1. Quality of Life. SF-36 Quality of Life Questionnaire [3 weeks]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
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:
  • 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).

Contacts and Locations

Locations

Site City State Country Postal Code
1 Niğde Ömer Halisdemir University Bor Physical Therapy Hospital Niğde Turkey 51100

Sponsors and Collaborators

  • Nigde Omer Halisdemir University

Investigators

  • Study Director: Gül PEHLİVAN TEKİN, Niğde Bor Physical Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Gül PEHLİVAN TEKİN, Lecturer, Nigde Omer Halisdemir University
ClinicalTrials.gov Identifier:
NCT05778890
Other Study ID Numbers:
  • Nigdeohu-ZHMYO-GPT-01
First Posted:
Mar 21, 2023
Last Update Posted:
Mar 21, 2023
Last Verified:
Mar 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Gül PEHLİVAN TEKİN, Lecturer, Nigde Omer Halisdemir University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 21, 2023