Temporomandibular DisorderNCT06343155
Effect of Chronic Low Back Pain Treatment on Temporomandibular Disorder"
A study testing Therapeutic Group and Rocabado's Group in people with Temporomandibular Disorder and Chronic Low-back Pain, run by Medipol University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 23 to 65 years
- Conditions the study is for
- Temporomandibular Disorder, Chronic Low-back Pain
- What is being tested?
- Therapeutic Group and Rocabado's Group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 11 Apr 2024to 3 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 23 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Gizem Ergezen Şahin, Asst. Prof. contact
Turkey (Türkiye)1 site
Istanbul Medipol University
Istanbul
İkra Çakıcı, +90 05426696487, ikrabayraktar951@gmail.com
About this study
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.
Read the 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
- Being tested
- Therapeutic Group, Rocabado's Group
- Keywords
- Temporomandibular disorder, Chronic low-back pain, Rocabado's exercise, Therapeutic lumbar exercise
- Medical subject headings
- Temporomandibular Joint Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Therapeutic GroupOther
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 GroupOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Therapeutic Group; Other: Rocabado's Group |
| Rocabado's Exercises | Active comparator | Each exercise will consist of 6 sets and 6 repetitions. Receives: Other: Rocabado's Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: six week
Secondary outcomes (2)
The Jaw Functional Limitation Scale 20 (JFLS-20)
The Jaw Functional Limitation Scale 20 (JFLS-20) will be used to measure changes in functional disability. The JFLS has 3 subcomponents: mastication, vertical jaw mobility, and emotional and verbal expression. The Jaw Functional Limitation Scale 20 (JFLS20) has a score range of 1 to 200, with higher scores indicating worsening jaw function.
Measured: six week
Oral Health Impact Profile - 14 (OHIP-14)
Quality of life was measured using 14 item OHIP-14 comprising 7 different domains (functional limitation, physical pain, psychological discomfort, psychological disability, physical disability, social disability, and handicap) [10]. Each domain was assessed by two questions, scored using a 5-point Likert scale (0 = never to 4 = very often). The total OHIP-14 score was derived by a summing of the domain scores. A higher score indicates a poorer quality of life
Measured: six week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2024
- Study start11 Apr 2024 (estimated)
- Primary completion27 May 2024 (estimated)
- Study completion3 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Temporomandibular DisorderStudies of the same condition, open and under way.
- More trials run by Medipol UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- There are two groups: Therapeutic group and Rocabado's group.
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medipol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ikra Cakici, Medipol University
- Investigators
- İkra Çakıcı, MD, Principal investigator, Medipol UniversityGizem Ergezen Şahin, Asst. Prof., Study director, Medipol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06343155
- Sponsor's protocol ID
- E-10840098-202.3.02-235
- Status last verified
- Apr 2024
- First submitted
- 27 Mar 2024
- Last updated
- 3 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 40415287
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Chronic Low Back Pain Treatment on Temporomandibular Disorder"
- ClinicalTrials.gov ID
- NCT06343155
- Acronym / sponsor ID
- E-10840098-202.3.02-235
- Conditions
- Temporomandibular Disorder, Chronic Low-back Pain
- Keywords
- Temporomandibular disorder, Chronic low-back pain, Rocabado's exercise, Therapeutic lumbar exercise
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Medipol UniversityUniversity, hospital or other
- Study start
- 11 Apr 2024 (estimated)
- Primary completion
- 27 May 2024 (estimated)
- Study completion
- 3 Jun 2024 (estimated)
- First posted
- 2 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- There are two groups: Therapeutic group and Rocabado's group.
| Arm | Type | Receives |
|---|---|---|
| Therapeutic Exercises | Experimental | Other: Therapeutic Group, Other: Rocabado's GroupParticipants 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. |
| Rocabado's Exercises | Active comparator | Other: Rocabado's GroupEach exercise will consist of 6 sets and 6 repetitions. |
Who may qualify
- Ages
- 23 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (7 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Therapeutic GroupPelvic 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. | Other | Therapeutic Exercises |
| Rocabado's GroupRest 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. | Other | Rocabado's Exercises, Therapeutic Exercises |
Primary outcome
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
2 secondary outcomes
The Jaw Functional Limitation Scale 20 (JFLS-20)
Time frame: six week
Oral Health Impact Profile - 14 (OHIP-14)
Time frame: six week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2024.
- Derived from this study: PubMed 40415287Cakici 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gizem Ergezen Şahin, Asst. Prof. contact
İkra Çakıcı, MD principal investigator
Medipol University
Gizem Ergezen Şahin, Asst. Prof. study director
Medipol University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Therapeutic Group and Rocabado's Group in people with Temporomandibular Disorder and Chronic Low-back Pain, run by Medipol University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact İkra Çakıcı, MD (+90 05426696487, ikrabayraktar951@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Temporomandibular Joint Range of Motion Measurement (ROM) (time frame: six week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06343155, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2024.