Clinical trial NCT06343155: Effect of Chronic Low Back Pain Treatment on Temporomandibular Disorder"
Official title: Effect of Chronic Low Back Pain Treatment on Temporomandibular Disorder"
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Temporomandibular Disorder
Chronic Low-back Pain
Keywords: Temporomandibular disorder
Chronic low-back pain
Rocabado's exercise
Therapeutic lumbar exercise
Lead sponsor: Medipol University
Sponsor class: OTHER
First posted: 2024-04-02
Enrollment: 40
Sex: ALL
Minimum age (years): 23
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: There are two groups: Therapeutic group and Rocabado's group.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Temporomandibular Joint Range of Motion Measurement (ROM)
timeFrame: six week
Secondary outcomes:
measure: The Jaw Functional Limitation Scale 20 (JFLS-20)
timeFrame: six week
measure: Oral Health Impact Profile - 14 (OHIP-14)
timeFrame: six week
Other outcomes:
measure: The short-form McGill Pain Questionnaire (SF-MPQ)
timeFrame: six weeks
measure: Graded Chronic Pain Scale 2.0 total (GCPS 2.0)
timeFrame: six week
measure: Visual Analog Scale
timeFrame: six week
Locations:
city: Istanbul
country: Turkey
facility: Istanbul Medipol University
Study officials:
affiliation: Medipol University
name: İkra Çakıcı, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Medipol University
name: Gizem Ergezen Şahin, Asst. Prof.
role: STUDY_DIRECTOR
References: