Clinical trial NCT04982601: Yoga-Based Exercise Program For Temporomandibular Disorders
Official title: Evaluation of Yoga-Based Exercise Program for Females With Temporomandibular Disorders: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Temporomandibular Disorders
Myofascial Pain Dysfunction Syndrome
Temporomandibular Joint Pain
Range of Motion
Yoga
Quality of Life
Lead sponsor: Medipol University
Sponsor class: OTHER
First posted: 2021-07-29
Enrollment: 39
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Aims:The study was conducted to investigate the effect of Yoga-based exercise program on pain, range of motion(ROM), sleep quality, depression and quality of life in female patients with myofascial pain dysfunction(MPD) of temporomandibular disorders .

Methods: MPD will be included in the study. Yoga based exercise program will be performed to the first group as 3 times in a week for 6 weeks. The second group will be the control group. Outcome measurements; pain ,sleep quality, depression and quality of life will be evaluated. Evaluations will be repeated before and 6 weeks after exercise.

Detailed description: Total 46 female patients between the ages of 20-50 planned to include in the study. In the study, 42 volunteers divided into two groups as yoga group (Group 1) and control group (Group 2). As a result of randomization, those chose 1 were taken in group 1, 2 were included in group 2. Yoga-based exercises performs for 6 weeks and 3 days in a week for the first group. The second group will be taken in the waiting list to be included in the program as a control group.

Yoga-based exercises perform by a physiotherapist has Yoga training, by consisting of 10-person groups, 6 weeks, 3 days in a week for a total of 18 sessions. Yoga-based exercises are Hatha yoga-based sessions consisting of breathing exercises, warm-up exercises, relaxation, asanas exercises and lasts about one hour.

Before the treatment, evaluations made immediately after the 6-weeks exercise program ended. As the primary outcome measures; jaw pain Visual Analog Scale (VAS), Neck Pain And Disability Scale (NPDS), neck and jaw range of motion (ROM) measurements; for secondary outcome measurements; the Pittsburg Sleep Quality Index (PUQI), Beck Depression Inventory (BDI) and Short Form 36 (SF36) are used. All measurements are repeated at the 6th week after yoga application and datas compared with the baseline measurements.

Eligibility criteria: Inclusion Criteria:

* Female patients aged 20-50 years diagnosed with MPD(myofascial pain dysfunction) syndrome according to the Research Diagnostic Criteria For Temporomandibular Disorders

Exclusion Criteria:

* Those with orthopedic problems such as degenerative arthritis and traumatic injuries, took physiotherapy program in the last 3 months and drug users were not included in the study.

Primary outcomes:
measure: Visual Analog Scale(VAS)
timeFrame: 6 weeks
measure: Neck Pain And Disability Scale (NPDS)
timeFrame: 6 weeks
measure: Neck and jaw range of motion (ROM)
timeFrame: 6 weeks
Secondary outcomes:
measure: Pittsburg Sleep Quality Index (PUQI)
timeFrame: 6 weeks
measure: Beck Depression Inventory (BDI)
timeFrame: 6 weeks
measure: Short Form 36 (SF36)
timeFrame: 6 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Medipol University
name: ESRA ATILGAN, PhD
role: PRINCIPAL_INVESTIGATOR
References: