Efficacy Of Different Types Of Physiotherapy Approaches In Temporomandibular Disorders

Not Applicable

Completed

• Conditions: Temporomandibular Disorder
• Interventions: Other: Exercise; Other: Patient Education; Other: Low Level Laser Therapy; Other: Manuel Pressure Release

• Registration Number: NCT04294602
• Lead Sponsor: Bitlis Eren University

Brief Summary

The aim of this study is to investigate the efficacy of different types of physiotherapy approaches in cases with cervical myofascial painful TMD.

Detailed Description

59 persons with TMD diagnosed by the dentist and with cervical myofascial pain, aged 18-30 years will be randomly allocated, 3 groups. The participants were randomly allocated only exercise group (EG) (n=20), low-level laser therapy plus exercise group (LLLT) (n=17) and manual pressure release plus exercise group (MPR) (n=22). The cases were evaluated and treated by the same physiotherapist for 4 weeks (12 sessions).

Pain, pain pressure threshold, temporomandibular joint (TMJ) mobility and disability, forward head posture, head rotation, neck disability, psychological status and quality of life were evaluated. Evaluations were repeated before and after treatment.

Study Timeline

• Study Start: 2017-05-15
• Primary Completion: 2018-03-13
• Study Completion: 2018-05-10
• Study First Submitted: 2020-02-29
• Status Verified: 2020-03
• Study First Submitted QC: 2020-03-02
• Last Update Submitted: 2020-03-02
• Study First Posted: 2020-03-04
• Last Update Posted: 2020-03-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 59

Inclusion Criteria

• Cases who have 3 or more symptoms related to TMJ problems
• cases who have trigger points in cervical and masticatory muscles
• cases who TMD detected by the dentist,
• being between the ages of 18-30,
• volunteer to participate in the study

Exclusion Criteria

• Patients with a positive history of trauma in the face and neck area and neurological disorders
• patients undergoing TMJ or cervical region surgery in the last 3 months,
• patients who used dental orthotics within 1 month,
• patients who have TMJ instability,
• patients who have cervical and upper thoracic region,
• patients who have active infection and chronic pain, such as trigeminal neuralgia

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Low Level Laser Therapy Program	Exercise	This group received LLLT, therapeutic exercises and patient education in the therapy programs. LLLT (max output power: 1200mW, wavelength: 808 nm, dosage: 10j/ cm2 Electronica Pagani Laser Tower Light, Italy) 2.5-4j/TrP dosage was applied to MTrP or sensitive points. The application was applied to MTrP or sensitive points in the mastication and cervical muscles.LLLT program was done in 3 days a week, the treatment program lasted 4 weeks.
Exercise Program	Exercise	This group received therapeutic exercises and patient education. For patients to encounter fewer problems and to reduce their problems, some recommendations were made that should be taken into consideration in daily life. These suggestions were given in writing. The exercise program included muscle stretching, massage of painful muscles, guided opening and closing movements, gentle isometric tension exercises against resistance, correction of body posture and relaxation techniques. All exercises were done in 6 repetitions a set, 3 sets a day, 3 days a week, treatment program lasted 4 weeks.
Exercise Program	Patient Education	This group received therapeutic exercises and patient education. For patients to encounter fewer problems and to reduce their problems, some recommendations were made that should be taken into consideration in daily life. These suggestions were given in writing. The exercise program included muscle stretching, massage of painful muscles, guided opening and closing movements, gentle isometric tension exercises against resistance, correction of body posture and relaxation techniques. All exercises were done in 6 repetitions a set, 3 sets a day, 3 days a week, treatment program lasted 4 weeks.
Low Level Laser Therapy Program	Low Level Laser Therapy	This group received LLLT, therapeutic exercises and patient education in the therapy programs. LLLT (max output power: 1200mW, wavelength: 808 nm, dosage: 10j/ cm2 Electronica Pagani Laser Tower Light, Italy) 2.5-4j/TrP dosage was applied to MTrP or sensitive points. The application was applied to MTrP or sensitive points in the mastication and cervical muscles.LLLT program was done in 3 days a week, the treatment program lasted 4 weeks.
Low Level Laser Therapy Program	Patient Education	This group received LLLT, therapeutic exercises and patient education in the therapy programs. LLLT (max output power: 1200mW, wavelength: 808 nm, dosage: 10j/ cm2 Electronica Pagani Laser Tower Light, Italy) 2.5-4j/TrP dosage was applied to MTrP or sensitive points. The application was applied to MTrP or sensitive points in the mastication and cervical muscles.LLLT program was done in 3 days a week, the treatment program lasted 4 weeks.
Manual Pressure Release Program	Patient Education	ThisThis group received manual pressure release (MPR), therapeutic exercises and patient education in the therapy programs. MPR technique is a noninvasive method based on pressure on the trigger point in accordance with the patient's tolerance and technique applies supine position relax as much as possible, MTrPs in the mastication and neck muscle. Applied pressure gradually with finger over the MTrPs until the subject reported a 'moderate but easily tolerable' pain value of 7 out of 10. When the pain value decreased to at least 3 or 4 therapist increased pressure again until discomfort and/or pain appeared again. This process was repeated until there was no MTrP tension/tenderness or 60 s had elapsed. MPR program was done in 3 days a week, the treatment program lasted 4 weeks.
Manual Pressure Release Program	Manuel Pressure Release	ThisThis group received manual pressure release (MPR), therapeutic exercises and patient education in the therapy programs. MPR technique is a noninvasive method based on pressure on the trigger point in accordance with the patient's tolerance and technique applies supine position relax as much as possible, MTrPs in the mastication and neck muscle. Applied pressure gradually with finger over the MTrPs until the subject reported a 'moderate but easily tolerable' pain value of 7 out of 10. When the pain value decreased to at least 3 or 4 therapist increased pressure again until discomfort and/or pain appeared again. This process was repeated until there was no MTrP tension/tenderness or 60 s had elapsed. MPR program was done in 3 days a week, the treatment program lasted 4 weeks.
Manual Pressure Release Program	Exercise	ThisThis group received manual pressure release (MPR), therapeutic exercises and patient education in the therapy programs. MPR technique is a noninvasive method based on pressure on the trigger point in accordance with the patient's tolerance and technique applies supine position relax as much as possible, MTrPs in the mastication and neck muscle. Applied pressure gradually with finger over the MTrPs until the subject reported a 'moderate but easily tolerable' pain value of 7 out of 10. When the pain value decreased to at least 3 or 4 therapist increased pressure again until discomfort and/or pain appeared again. This process was repeated until there was no MTrP tension/tenderness or 60 s had elapsed. MPR program was done in 3 days a week, the treatment program lasted 4 weeks.

Primary Outcome Measures

Name	Time	Method
Pain Severity Assessment	Change from baseline TMJ pain and intensity of head pain, TMJ noise and jaw locking score at week 4.	To evaluate the general pain severity of the patients, the Visual Analog Scale (VAS), which is the Visual Pain Scale of Turkish, was used. Patients were asked to mark their general pain separately on a 10 cm scale. According to this, "0" indicates that there is no pain, and "10" indicates the most severe pain. The distance between the marked point and the beginning of the line was recorded in centimeters
Jaw Movements Assessment	Change from baseline MMO and lateral deviation score at week 4.	Maximum mouth opening (MMO) and lateral deviation were measured with a caliper.
Quality of Life Assesment	Change from baseline quality of life score at week 4	Short Form-36 questionnaire contains the physical and mental component, which is evaluated, is close to 100, indicating an increase in health-related quality of life. The means SF-36 score ranging from 0 (worst) to 100 (best).
Temporomandibular Disorder Severity	Change from baseline temporomandibular disorder severity score at week 4	The TMD severity in participation is defined by the Craniomandibular Index (CMI) which was developed to provide a standardized measure to the severity of problems in mandibular movement, muscle, and joint tenderness and TMJ noise for use in epidemiological and clinical outcome studies. The instrument was designed to have clearly defined objective criteria, simple clinical methods, and ease in scoring; it is divided into the Palpation Index (PI) and the Dysfunction Index (DI). The means of the subscales were averaged to produce a CMI score ranging from 0 (best) to 1 (worst)
Pressure Pain Threshold Assessment	Change from baseline pressure pain threshold score in neck and mastication muscles at week 4.	Pressure Pain Threshold (PPT) of an individual's mastication and cervical muscle was measured with an algometer (JTECH Medical Industries, CommanderTMAlgometer), and the applied pressure was increased to 1 cm2/ kg per second. PPT measurements were repeated three times and the average was used for analysis in every participant.
Neck Movements Assessment	Change from baseline cervical rotations and craniovertebral angle score at week 4.	Cervical rotations and the craniovertebral angle between C7 and tragus were measured by a goniometer.

Secondary Outcome Measures

Name	Time	Method
Psychological Status Assesment	Change from baseline psychological status score at week 4.	Beck depression index which is a two-factor scale, emotion and somatic, has 21 questions, the lowest score is 0 and the highest score is 3 in each question. The means Beck depression index score ranging from 0 (best) to 63 (worst).
Neck Disability Assesment	Change from baseline neck disability score at week 4.	Northwick Park Neck Pain Questionnaire; Neck pain severity, neck pain and sleep, numbness and tingling in the arms at night, duration of symptoms and complaints, weight-bearing, reading and watching television, work and housework, social activities and driving includes 9 items. Each item consists of 5 options, the level of disability increases as you approach 36 points. The means northwick park neck pain questionnaire score ranging from 0 (best) to 36 (worst).

Trial Locations

Locations (1)

Marmara University; 🇹🇷 Istanbul, Maltepe, Turkey