Effect of Chronic Low Back Pain Treatment on Temporomandibular Disorder"

NCT ID: NCT06343155

Last Updated: 2024-04-03

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-11
• Study Completion Date: 2024-06-03

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.

Conditions

Temporomandibular Disorder; Chronic Low-back Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Therapeutic Exercises

Participants will be planned to participate in therapeutic lumbar exercises in groups of 5, in the morning and at noon, via the Zoom Platform in 40-minute sessions, 3 days a week, with a physiotherapist, for 6 weeks. Additionally, participants will do Rocabado's exercise at home. All exercises will be taught face to face in the first session. Online sessions with the physiotherapist will continue. A 5-minute warm-up and cool-down period and a 30-minute exercise period are planned. Patients will be asked to perform the exercises in 3 sets of 10-15 repetitions and will be allowed to rest for 10 seconds. Every exercise performed unilaterally will be performed bilaterally.

Group Type: EXPERIMENTAL

Therapeutic Group

Intervention Type: OTHER

Pelvic tilt exercise:Participant will be supine position on the floor with your knees bent. Flatten your back against the floor by tightening your abdominal muscles and bending your pelvis up slightly. Lumbar flexion(single knee to chest): Participants will be supine position with knees bent and feet flat on the floor. The right knee will be brought closer to your chest and held with the hands. Lumbar flexion(double knee to chest) : Participants will be supine position with both legs flat on the floor. One hip and knee will be bent first to the chest, then the other to the chest. The knees will be grasped with the hands. Straight Leg Raise: Participants will be supine position with hips and legs comfortably on the floor. By contracting the quadriceps muscle the straight leg will be fixed. Inhaling slowly, the straight leg will be lifted six inches off the floor. Spine twist: Participants will turn their hips and knees to one side as much as possible in a supine position.

Rocabado's Group

Intervention Type: OTHER

Rest position of tongue: Making a 'clucking' sound positions the tongue against the hard palate in the correct resting position for appropriate nasal and diaphragmatic breathing. Once the activity is practiced, the patient is to attempt to maintain appropriate tongue / jaw resting position throughout normal activity. Shoulder retraction:Sitting up nice and tall, squeeze your shoulder blades back and together. Stabilized head posture:Place your hands behind your hand with fingers interlocked.Gently bring head forward with gentle overpressure from hands.Axial extension of the neck: Sitting up nice and bring your chin backward as if trying to make a double chin. Rotation control of temporomandibular joint: Place tongue at the roof of your mouth just behind your front teeth and place fist underneath chin. Gently open mouth into fist and hold for a few seconds. Rhythmic stabilization:Patients apply resistance to opening, closing, and lateral deviation with the jaw in a resting position.

Rocabado's Exercises

Each exercise will consist of 6 sets and 6 repetitions.

Group Type: ACTIVE_COMPARATOR

Rocabado's Group

Intervention Type: OTHER

Rest position of tongue: Making a 'clucking' sound positions the tongue against the hard palate in the correct resting position for appropriate nasal and diaphragmatic breathing. Once the activity is practiced, the patient is to attempt to maintain appropriate tongue / jaw resting position throughout normal activity. Shoulder retraction:Sitting up nice and tall, squeeze your shoulder blades back and together. Stabilized head posture:Place your hands behind your hand with fingers interlocked.Gently bring head forward with gentle overpressure from hands.Axial extension of the neck: Sitting up nice and bring your chin backward as if trying to make a double chin. Rotation control of temporomandibular joint: Place tongue at the roof of your mouth just behind your front teeth and place fist underneath chin. Gently open mouth into fist and hold for a few seconds. Rhythmic stabilization:Patients apply resistance to opening, closing, and lateral deviation with the jaw in a resting position.

Interventions

Therapeutic Group

Pelvic tilt exercise:Participant will be supine position on the floor with your knees bent. Flatten your back against the floor by tightening your abdominal muscles and bending your pelvis up slightly. Lumbar flexion(single knee to chest): Participants will be supine position with knees bent and feet flat on the floor. The right knee will be brought closer to your chest and held with the hands. Lumbar flexion(double knee to chest) : Participants will be supine position with both legs flat on the floor. One hip and knee will be bent first to the chest, then the other to the chest. The knees will be grasped with the hands. Straight Leg Raise: Participants will be supine position with hips and legs comfortably on the floor. By contracting the quadriceps muscle the straight leg will be fixed. Inhaling slowly, the straight leg will be lifted six inches off the floor. Spine twist: Participants will turn their hips and knees to one side as much as possible in a supine position.

Intervention Type: OTHER

Rocabado's Group

Rest position of tongue: Making a 'clucking' sound positions the tongue against the hard palate in the correct resting position for appropriate nasal and diaphragmatic breathing. Once the activity is practiced, the patient is to attempt to maintain appropriate tongue / jaw resting position throughout normal activity. Shoulder retraction:Sitting up nice and tall, squeeze your shoulder blades back and together. Stabilized head posture:Place your hands behind your hand with fingers interlocked.Gently bring head forward with gentle overpressure from hands.Axial extension of the neck: Sitting up nice and bring your chin backward as if trying to make a double chin. Rotation control of temporomandibular joint: Place tongue at the roof of your mouth just behind your front teeth and place fist underneath chin. Gently open mouth into fist and hold for a few seconds. Rhythmic stabilization:Patients apply resistance to opening, closing, and lateral deviation with the jaw in a resting position.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 23 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medipol University

OTHER

Sponsor Role: lead

Responsible Party

Ikra Cakici

graduate student

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

İkra Çakıcı, MD

Role: PRINCIPAL_INVESTIGATOR

Medipol University

Gizem Ergezen Şahin, Asst. Prof.

Role: STUDY_DIRECTOR

Medipol University

Locations

Istanbul Medipol University

Istanbul, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Central Contacts

İkra Çakıcı, MD

Role: CONTACT

ikrabayraktar951@gmail.com

+90 05426696487

Gizem Ergezen Şahin, Asst. Prof.

Role: CONTACT

gergezen@medipol.edu.tr

Facility Contacts

İkra Çakıcı

Role: primary

ikrabayraktar951@gmail.com

+90 05426696487

References

Cakici I, Sahin GE. Exercise based multisite pain management in temporomandibular dysfunction and chronic low back pain: a randomized controlled trial. Physiother Theory Pract. 2025 Oct;41(10):2191-2201. doi: 10.1080/09593985.2025.2507848. Epub 2025 May 25.

Reference Type: DERIVED

PMID: 40415287 (View on PubMed)

Other Identifiers

E-10840098-202.3.02-235

Identifier Type: -

Identifier Source: org_study_id