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Clinical Trials/NCT06343155
NCT06343155UnknownNot Applicable

Effect of Chronic Low Back Pain Treatment on Temporomandibular Disorder"

Medipol University2 sites in 2 countries40 target enrollmentStarted: April 11, 2024Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Sponsor
Enrollment
40
Locations
2
Primary Endpoint
Temporomandibular Joint Range of Motion Measurement (ROM)

Study Overview

Brief Summary

According to the information obtained from clinical studies, it has been stated that Temporomandibular Disorder (TMD) is associated with chronic low back pain (LBP). In this study, participants will be divided into two groups. Only Rocabado's exercise will be given to the Rocabado's group (RG), and Rocabado's and therapeutic lumbar exercises will be given to the therapeutic group (TG). Warm-up exercises will be given before starting the exercises with the therapeutic group, and cool-down exercises will be given after the exercises with the therapeutic group. At the end of the sixth week, the effect of therapeutic lumbar exercises on TMD pain and function will be evaluated.

Detailed Description

Studies indicate that TMD could coexist with low back pain. It has been proven in studies that physiotherapy reduces inflammation, joint pain, and mandibular movement limitation in TMD patients. The most common exercise known for TMD is defined as Rocabado's exercise 6x6. Each exercise is given in 6 sets of 6 repetitions. Rocabado's described techniques to facilitate neuromuscular stabilization using repeated lateral deviation movements. This technique can be used as a proprioceptive exercise method to increase functionality in areas where there is no pain. For patients with low back pain, our treatment goal is to minimize bed rest and restore functionality as soon as possible. Physiotherapy is recommended for patients with low back pain, and an exercise program is created according to the reasons and demands of the patients. There are many different intervention options, such as aerobic exercises, stretching exercises, and muscle building. Therapeutic exercises show positive results in low back and neck pain. In studies conducted in the treatment of TMD, the effect of therapeutic exercises on pain is still not fully known. Our aim in our study is to examine the effect of chronic low back pain treatment on temporomandibular disorder. Participants will be divided into two groups: the therapeutic group and the Rocabado's group. The therapeutic group will receive therapeutic lumbar exercises via remote online video for 6 weeks and will additionally be asked to do the Rocabado's exercise. Rocabado's exercises will be given to the Rocabado's group only as home exercises. In order to compare the effects of these techniques with each other, pre-treatment and post-treatment evaluations will be made for both groups.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
23 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Between the ages 23-65
  • Pain in the Temporomandibular Joint area for at least 3 months
  • Participants had low back pain complaints for at least 6 months and were diagnosed with chronic low back pain.

Exclusion Criteria

  • History of trauma, anatomical deformities and fractures,
  • Diagnosed orthopedic or rheumatological diseases,
  • Acute trauma or infection in relevant areas,
  • Pregnancy,
  • Having received TMD treatment or been included in a physiotherapy program in the last 6 months,
  • History of vertebral fracture in the last 6 months,
  • Individuals with a history of surgery in the lumbar region.

Outcomes

Primary Outcomes

Temporomandibular Joint Range of Motion Measurement (ROM)

Time Frame: six week

Pain-free Mouth Opening (PMO):A premeasured mm caliper was attached to each participant's chin as a reference. Each participant will be instructed to open their mouth as wide as possible to the point where there is no pain.Maximum Unassisted Mouth Opening(MAO) It will be defined as the maximum distance a subject can open his mouth without feeling any pain. After the patient opens his mouth wide in this way, mouth opening will be measured.Maximum Assisted Mouth Opening(MAO): Once the patient is this open, the investigator will place his or her fingers on the patient's upper and lower central incisors, forcing the patient's mouth to open wider. Right Lateral Movement (RML)-Left Lateral Movement (LLM): Lateral right and left movements:Lateral right and left movements: For these measurements it is recommended the demarcation of two reference points, on the maxilla and mandible, close to the midline

Secondary Outcomes

  • The Jaw Functional Limitation Scale 20 (JFLS-20)(six week)
  • Oral Health Impact Profile - 14 (OHIP-14)(six week)

Investigators

Sponsor
Medipol University
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Ikra Cakici

graduate student

Medipol University

Study Sites (2)

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