NCT04982601

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
39

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2014

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 7, 2014

Completed
5.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 7, 2019

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 7, 2020

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

July 8, 2021

Completed
21 days until next milestone

First Posted

Study publicly available on registry

July 29, 2021

Completed
Last Updated

July 29, 2021

Status Verified

July 1, 2021

Enrollment Period

5.4 years

First QC Date

July 8, 2021

Last Update Submit

July 28, 2021

Conditions

Outcome Measures

Primary Outcomes (3)

  • Visual Analog Scale(VAS)

    Pain intensity felt in the chin was evaluated with VAS at rest. They were asked to draw their pain level on a 10 cm scale between 0-10 points as 0=no pain, 10 unbearable pain

    6 weeks

  • Neck Pain And Disability Scale (NPDS)

    It is examined with Neck Pain and Disability Scale (NPDS). The severity of neck pain, duration of symptoms, and the disability of each item in the specified activities are evaluated. Each item is scored between 0-5 points. The total score is the sum of the points in each item and ranges from 0 to 100. High scores indicate more severe pain and effect

    6 weeks

  • Neck and jaw range of motion (ROM)

    The neck and chin area of the patients were measured with a ROM universal goniometer. While neck normal joint motion flexion (0-65 °), extension (50 °), lateral flexion (45 °) and rotation (60-80 °) were measured, TMJ movements, mandibular depression, protrusion, deviation movements were measured. Measurements were taken 3 times and the mean value was recorded

    6 weeks

Secondary Outcomes (3)

  • Pittsburg Sleep Quality Index (PUQI)

    6 weeks

  • Beck Depression Inventory (BDI)

    6 weeks

  • Short Form 36 (SF36)

    6 weeks

Study Arms (2)

Yoga Group

EXPERIMENTAL

Yoga-based exercises were performed 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. Especially combined movements with upper extremity and neck movements and breathing exercises were used in breathing exercises. In the warm-up exercises, the muscles were extended by giving exercises especially for stretching the muscles. In this way, asanas were prepared. Asanas Ardra kati cahkrasana, padahastasana, trikosana, sasankasana, varaksana poses have been performed. Asanas were modified and applied according to the patient's condition. Relaxation exercises were used both after breathing exercises and at the end of the exercise program. With relaxation, the patients were allowed to leave their muscles relaxed with the whole body relaxation

Other: Yoga Exercises

Control Group

NO INTERVENTION

No kind of intervention has been applied to control group they awaited for therapy procedure for 6 week. They have assessed at the end of the 6 weeks.

Interventions

Yoga-based exercises are Hatha yoga-based sessions consisting of breathing exercises, warm-up exercises, relaxation, asanas exercises.

Yoga Group

Eligibility Criteria

Age20 Years - 50 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsTMD has been reported that it is more common in women than men, as 5 times.
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Temporomandibular Joint DisordersFibromyalgia

Condition Hierarchy (Ancestors)

Craniomandibular DisordersMandibular DiseasesJaw DiseasesMusculoskeletal DiseasesJoint DiseasesMuscular DiseasesStomatognathic DiseasesRheumatic DiseasesNeuromuscular DiseasesNervous System Diseases

Study Officials

  • ESRA ATILGAN, PhD

    Medipol University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor PhD

Study Record Dates

First Submitted

July 8, 2021

First Posted

July 29, 2021

Study Start

January 7, 2014

Primary Completion

June 7, 2019

Study Completion

June 7, 2020

Last Updated

July 29, 2021

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will not share