Van Yüzüncü Yıl University
Van, Tuşba, 65080, Turkey (Türkiye)
NCT Number: NCT07577687
Temporomandibular joint dysfunction (TMD) is a multifactorial musculoskeletal disorder affecting the masticatory muscles, temporomandibular joint, and related structures, characterized by pain and functional limitations. In TMD, myofascial pain is particularly prominent, leading to decreased mandibular range of motion, impaired masticatory function, and reduced quality of life. Current literature shows that conservative treatment approaches, especially multimodal physiotherapy programs, are effective in reducing TMD symptoms. However, evidence regarding the clinical effectiveness of adding EMG-Biofeedback-based relaxation training, aimed at increasing awareness of muscle activity, to multimodal treatment programs is limited. The aim of this randomized controlled trial is to investigate the effect of EMG-Biofeedback-based relaxation training, added to a multimodal exercise program, on pain levels and functional parameters in individuals diagnosed with temporomandibular joint dysfunction. Participants will be divided into two groups using a simple randomization method. The control group will receive multimodal physiotherapy consisting of manual therapy and a home exercise program, while the experimental group will receive EMG-Biofeedback-based relaxation training in addition to the same program. Assessments will be conducted before the intervention and at the end of the 4-week intervention.
Pain intensity will be measured with a Visual Analog Scale (VAS), pressure pain threshold with a digital algometer, mandibular joint range of motion with a linear scale, and cervical joint range of motion with a digital goniometer. Functional status will be assessed using the Fonseca Anamnestic Index, Neck Disability Index, and Oral Health Impact Profile-14. The obtained data will be compared using appropriate statistical analysis methods. This study is expected to provide scientific evidence regarding the clinical effectiveness of adding EMG-Biofeedback-based relaxation training to multimodal exercise programs in the conservative treatment of TMD and to contribute to filling the methodological gap mentioned in the literature.
Trial opening soon.
Get Notified18 year–65 year
All sexes
Interventional
Not applicable
Van, Tuşba, 65080, Turkey (Türkiye)
The primary aim of this study is to investigate the effect of EMG-Biofeedback-based relaxation training, added to a multimodal exercise program, on pain levels and temporomandibular joint function in individuals diagnosed with temporomandibular joint dysfunction (TMD). It is known that in TMD, myofascial muscle pain is particularly prominent, and increased masticatory muscle activity leads to involuntary contractions and increased pain sensitivity, negatively impacting chewing, speaking, and daily living activities. This reduces the individual's functional capacity and quality of life. Therefore, this study aims to determine the contribution of adding EMG-Biofeedback-based relaxation training, which aims to increase awareness of muscle activity and promote neuromuscular relaxation, to a multimodal physiotherapy program to clinical outcomes. The primary objective of this study is to evaluate the change in pain level after the intervention. Pain will be assessed using the Visual Analog Scale (VAS), a subjective assessment method, and pressure pain threshold measurements using a digital algometer, an objective measurement method. The values obtained before and after the intervention will be compared both within and between groups. The secondary objectives of the study are to determine the changes in maximum mouth opening and mandibular range of motion, cervical joint range of motion, functional status (Fonseca Anamnestic Index), neck disability level, and quality of life related to oral health. In this context, the measurable objectives of the study are as follows:
The Neck Disability Index (NDI) was developed by Vernon et al. in 1991, and its Turkish validity and reliability were confirmed. This questionnaire shows the extent to which neck pain affects the quality of life of the participants. The questionnaire has options from A to F for each question. Participants will be asked to mark the option closest to them. For each question, A (0 points), B (1 point), C (2 points), D (3 points), E (4 points), F (5 points). A total score will be calculated.
The Oral Health Impact Profile-14 (ASEP-14) will be used to assess the impact of oral health on quality of life. This is a questionnaire that shows the extent to which oral health affects quality of life. This scale, consisting of 14 questions in total, includes functional limitations, physical pain, psychological distress, physical, social and psychological disabilities, and impairments.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
A comprehensive physiotherapy program consisting of manual therapy and home exercises will be implemented for 5 weeks (multimodal exercises will be performed by a physiotherapist in the clinic one day a week, and home exercises will be performed by the patient at home on the other two days of the week).
The EMG-Biofeedback program will include relaxation-based video games to reduce muscle activation. In addition to the multimodal physiotherapy program (manual therapy + home exercises), 20 minutes of relaxation training with EMG-Biofeedback will be provided. EMG-Biofeedback will be applied bilaterally to the masseter, temporalis, sternoclavicular carotid artery (SCM), and upper trapezius muscles. For each muscle, superficial electrode placement will be done on the muscle body along the direction of the muscle fibers. Electrode placement will be performed bilaterally with participants seated in a back-supported chair, feet on the floor, head and cervical region in neutral alignment, and mandible in a resting position (without teeth touching). Each muscle will receive 5 minutes of application.
Time frame: From enrollment to the end of treatment at 4 and 16 weeks
Pain severity on temporomandibular joint will be assessed with Visual Analog Scale. Individuals will be informed that pain intensity is assessed using a scale where 0 points represent "no pain" and 10 points represent "unbearable pain." They will then be asked to mark the point on a horizontal plane that best expresses the intensity of their pain. The score obtained will be recorded as their pain intensity. Individuals' pain will be assessed separately according to this scale while eating, yawning, and resting.
Time frame: From enrollment to the end of treatment at 4 and 16 weeks
Pressure pain threshold on temporomandibular joint will be assessed using Digital Algometer
Time frame: From enrollment to the end of treatment at 4 and 16 weeks
Maximum mouth opening, protrusion, and right and left lateral extrusion movements will be measured using a linear ruler. Individuals will be asked to perform these movements as much as possible without causing pain while in a seated position. The distance between the maxillary and mandibular central incisors will be measured using a millimeter ruler.
Time frame: From enrollment to the end of treatment at 4 and 16 weeks
The Fonseca Anamnestic Index will be used to assess TMJ functionality and disease symptoms. The questionnaire consists of 10 questions offering a comprehensive approach to evaluating temporomandibular joint, head, and back pain in the presence of chewing habits, parafunctional behaviors, movement restrictions, joint sounds, malocclusion, and emotional stress.
Time frame: From enrollment to the end of treatment at 4 and 16 weeks
The Oral Health Impact Profile-14 will be used to assess the impact of oral health on quality of life. It is a questionnaire that shows the extent to which oral health affects quality of life.
Time frame: From enrollment to the end of treatment at 4 and 16 weeks
A digital goniometer will be used to assess cervical range of motion (ROM). Cervical flexion, extension, right and left lateral flexion, and right and left rotation degrees will be recorded before and after treatment.
Time frame: From enrollment to the end of treatment at 4 and 16 weeks
Neck Functionality will be assessed with Neck Disability Index.
Time frame: From enrollment to the end of treatment at 4 and 16 weeks
Sleep quality will be assessed using the Pittsburg Sleep Quality Index.
Time frame: From enrollment to the end of treatment at 4 and 16 weeks
Patient satisfaction will be assessed with Visual Analog Scale.
Contact information is provided by the study sponsor or research team.
Yuzuncu Yil University
Other
The Effect of Emg-Biofeedback Based Relaxation Training Added to a Multimodal Exercise Program on Pain and Function in Patients With Temporomandibular Joint Dysfunction
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