Effect of Chronic Low Back Pain Treatment on Temporomandibular Disorder"

NCT06343155 | Not Yet Recruiting

• 1 other identifier: E-10840098-202.3.02-235
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Temporomandibular Disorder; Chronic Low-back Pain

Keywords

Temporomandibular disorder; Chronic low-back pain; Rocabado's exercise; Therapeutic lumbar exercise

Outcome Measures

Primary Outcomes (1)

• Temporomandibular Joint Range of Motion Measurement (ROM)

  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

  six week

Secondary Outcomes (2)

• The Jaw Functional Limitation Scale 20 (JFLS-20)

  six week

• Oral Health Impact Profile - 14 (OHIP-14)

  six week

Other Outcomes (3)

• The short-form McGill Pain Questionnaire (SF-MPQ)

  six weeks

• Graded Chronic Pain Scale 2.0 total (GCPS 2.0)

  six week

• Visual Analog Scale

  six week

Study Arms (2)

Therapeutic Exercises

EXPERIMENTAL

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.

Other: Therapeutic Group; Other: Rocabado's Group

Rocabado's Exercises

ACTIVE COMPARATOR

Each exercise will consist of 6 sets and 6 repetitions.

Other: Rocabado's Group

Interventions

Therapeutic Group 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.

Therapeutic Exercises

Rocabado's Group 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; Therapeutic Exercises

Eligibility Criteria

• Age: 23 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medipol University: lead

Study Sites (1)

Istanbul Medipol University

Istanbul, Turkey (Türkiye)

Location

Related Publications (1)

• 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.

  PMID: 40415287 DERIVED

MeSH Terms

Conditions

Temporomandibular Joint Disorders

Interventions

Self-Help Groups

Condition Hierarchy (Ancestors)

Craniomandibular Disorders; Mandibular Diseases; Jaw Diseases; Musculoskeletal Diseases; Joint Diseases; Muscular Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Organizations; Health Care Economics and Organizations

Study Officials

• İkra Çakıcı, MD

  Medipol University

  PRINCIPAL INVESTIGATOR

• Gizem Ergezen Şahin, Asst. Prof.

  Medipol University

  STUDY DIRECTOR

Central Study Contacts

İkra Çakıcı, MD

CONTACT

+90 05426696487; ikrabayraktar951@gmail.com

Gizem Ergezen Şahin, Asst. Prof.

CONTACT

gergezen@medipol.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: graduate student

Model Details: There are two groups: Therapeutic group and Rocabado's group.

Study Record Dates

• First Submitted: March 27, 2024
• First Posted: April 2, 2024
• Study Start: April 11, 2024
• Primary Completion: May 27, 2024
• Study Completion: June 3, 2024
• Last Updated: April 3, 2024

Record last verified: 2024-04

Locations

TU (1)