Temporomandibular Joint DysfunctionNCT07226505
Effects of Core Strengthening Exercises for Treating TMD
A study testing Experimental: Group 1: Core Strengthening and Group 2: Standard TMD PT in people with Temporomandibular Joint Dysfunction and TMD, run by Loyola University at 1 site in United States.
Trial summary
Temporomandibular disorders (TMD) are commonly managed with non-invasive interventions such as manual therapy, therapeutic exercise, relaxation techniques, and patient education. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Temporomandibular Joint Dysfunction, TMD, TMJ Internal Derangement
- What is being tested?
- Experimental: Group 1: Core Strengthening and Group 2: Standard TMD PT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2025to 31 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who Can Participate (Inclusion Criteria):
Adults between 18 and 70 years old.
Have had jaw pain or problems with the jaw joint (TMD) in the last 30 days.
Able and willing to attend at least six physical therapy sessions over three months.
Speak English or have access to a qualified interpreter.
Able to safely do physical exercises.
Who Cannot Participate (Exclusion Criteria):
Recently had surgery on the jaw, teeth, or spine (within the last 3 months).
Recently had head or neck injuries or certain neurological problems (such as dizziness, double vision, trouble swallowing, or sudden falls).
Are pregnant or become pregnant during the study.
Currently doing physical therapy for other movement problems that could affect the study.
Have had lower back or pelvic health issues in the last 3 months.
Currently receiving chemotherapy or radiation for cancer in the head, neck, pelvis, spine, or hip.
Wear dentures or cannot safely perform exercises.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Loyola University Medical Center
Maywood, Illinois, 60153
Dr. Margaret Miller, MD, (888) 584-7888, Margaret.Miller001@luhs.org
Dr. Margaret Miller, MD, Margaret.Miller001@luhs.org
About this study
Official title: A Randomized Trial Analyzing the Effects of Core Strengthening Exercises in Physical Therapy for Treating Temporomandibular Joint Dysfunction
Temporomandibular disorders (TMD) are commonly managed with non-invasive interventions such as manual therapy, therapeutic exercise, relaxation techniques, and patient education. Core strengthening (also known as abdominal strengthening) is a fundamental element of physical therapy that engages deep and superficial trunk musculature to enhance postural control and functional performance. Protocols such as the Shirley Sahrmann progression have demonstrated increased activation of key core stabilizing muscles. Emerging evidence suggests a potential relationship between core stability training and reductions in TMD-related pain, though improvements in functional outcomes remain inconclusive. Biomechanical links between the pelvic floor, spine, and temporomandibular joint further support the rationale for core-focused interventions. Nevertheless, few studies have isolated the effects of core strengthening on TMD symptomatology. This study seeks to determine whether the integration of core stability exercises into TMD management can reduce pain, improve function, and enhance quality of life.
Read the detailed description
This single-blinded randomized controlled trial will evaluate the effects of core strengthening exercises in addition to standard physical therapy for patients with Temporomandibular Joint Dysfunction (TMD). The study aims to determine whether integrating core stability exercises can reduce TMD-related pain, improve function, and enhance quality of life compared to standard physical therapy alone.
A total of 50 participants, aged 18-70, who have a primary complaint of TMD within the last 30 days and are willing to complete at least six physical therapy visits over a three-month period will be enrolled. Participants must speak English or have access to a verified interpreter and be able to safely participate in exercise.
Participants will be randomly assigned to one of two groups:
Group 1: Core strengthening exercises (Shirley Sahrmann progression) combined with standard TMD physical therapy, including therapeutic exercises, manual interventions, soft tissue mobilization, neuromuscular re-education, and education. Home exercise programs will support adherence.
Group 2: Standard TMD physical therapy alone, including the same therapeutic exercises, manual interventions, soft tissue mobilization, neuromuscular re-education, and education.
Key exclusion criteria include recent TMJ or spinal surgery, recent head/neck trauma or neurologic symptoms, pregnancy, concurrent physical therapy for other movement disorders, low back or pelvic health dysfunction in the past three months, use of dentures, or current chemotherapy/radiation involving the head, neck, pelvis, spine, or hip.
Participants will undergo initial evaluation, intervention sessions, and post-treatment assessment by blinded evaluating therapists to measure pain, function, and core strength outcomes. Safety will be continuously monitored throughout the study.
- Being tested
- Experimental: Group 1: Core Strengthening, Group 2: Standard TMD PT
- Keywords
- Core strengthening, physical therapy, RCT
- 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.
Experimental: Group 1: Core StrengtheningBehavioural
Also called Shirley Sahrmann Core Stability Protocol
Participants perform Shirley Sahrmann core exercises (5 progressive levels maintaining neutral spine and deep core activation), possibly adding upper extremity movements. Standard TMD PT includes jaw exercises, manual therapy, soft tissue mobilization, neuromuscular re-education, and patient education. A home exercise program (~20 min/day) is provided with printed and video instructions.
Group 2: Standard TMD PTBehavioural
Also called Rocabado 6x6 Exercises
Participants receive standard TMD PT including jaw exercises (Rocabado 6x6), manual therapy for TMJ and cervical spine, soft tissue mobilization, neuromuscular re-education to improve jaw mechanics, and education on jaw positioning, diet/chewing modifications, and parafunctional habits. A home exercise program is provided as part of treatment.
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Core Strengthening + Standard TMD Physical Therapy | Experimental | Participants in this group will receive the Shirley Sahrmann core strengthening protocol, which involves progressive levels of dynamic movements designed to maintain a neutral spine and activate deep core muscles. Exercises begin in hook-lying or supine positions, with gradual progression through five levels, and may include upper extremity movements once core control is achieved. In addition, participants will follow a structured home exercise program with daily exercises (approximately 20 minutes), supported with printed instructions and video demonstrations through the MedBridge platform. Receives: Behavioral: Experimental: Group 1: Core Strengthening; Behavioral: Group 2: Standard TMD PT |
| Group 2: Standard TMD Physical Therapy | Active comparator | Participants in this group will receive standard physical therapy for TMD, including:
Therapeutic exercises (e.g., Rocabado 6x6) for jaw mobility and posture.
Manual therapy to restore normal TMJ and cervical spine joint mechanics.
Soft tissue mobilization targeting masticatory and cervical muscles as clinically indicated.
Education on jaw rest position, diet/chewing modifications, and avoidance of parafunctional habits.
Neuromuscular re-education to improve TMJ opening mechanics, including deep neck flexor activation and mirror training. Receives: Behavioral: Group 2: Standard TMD PT |
What is being measured
The primary outcome is the main question the study is designed to answer.
TMD Pain (e.g., Visual Analog Scale/Numeric Pain Rating)
Measured: Baseline and post-intervention (6 PT sessions), assessed up to 6 weeks
Secondary outcomes (3)
Neck Disability Index (NDI)
This measure evaluates how neck pain affects a person's ability to perform everyday activities. It uses the Neck Disability Index (NDI), a questionnaire scored from 0% to 100%, where 0% means no disability and 100% represents complete disability in daily life.
Measured: Baseline and post-intervention (6 PT sessions), assessed up to 6 weeks
Compliance with Home Exercise Program (HEP)
Assessed via participant-completed exercise diaries, tracking adherence to prescribed daily exercises.
Measured: Throughout the 6-week intervention period (daily tracking, summarized at post-intervention)
Functional Measures from TMJ Scale
This measure objectively evaluates jaw movement and functional performance, including mobility, deviation, and deflection. It uses the Temporomandibular Disorder (TMD) Dysfunction Scale, which consists of 10 questions scored from 0 to 4. The total score is converted to a percentage, where higher percentages reflect greater levels of dysfunction or disability.
Measured: Baseline and post-intervention (6 PT sessions), assessed up to 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2025
- Study start1 Nov 2025 (estimated)
- Primary completion1 Dec 2026 (estimated)
- Study completion31 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Temporomandibular Joint DysfunctionStudies of the same condition, open and under way.
- 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Loyola University
- Sponsor type
- University, hospital or other
- Collaborators
- Loyola University Chicago
- Responsible party
- Principal investigator, Margaret Miller, Loyola University Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07226505
- Sponsor's protocol ID
- 219911
- Status last verified
- Oct 2025
- First submitted
- 30 Oct 2025
- Last updated
- 10 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial Analyzing the Effects of Core Strengthening Exercises in Physical Therapy for Treating Temporomandibular Joint Dysfunction
- ClinicalTrials.gov ID
- NCT07226505
- Acronym / sponsor ID
- 219911
- Keywords
- Core strengthening, physical therapy, RCT
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Loyola UniversityUniversity, hospital or other
- Collaborators
- Loyola University Chicago
- Study start
- 1 Nov 2025 (estimated)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 31 Jan 2027 (estimated)
- First posted
- 10 Nov 2025 (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.
Temporomandibular disorders (TMD) are commonly managed with non-invasive interventions such as manual therapy, therapeutic exercise, relaxation techniques, and patient education. Core strengthening (also known as abdominal strengthening) is a fundamental element of physical therapy that engages deep and superficial trunk musculature to enhance postural control and functional performance. Protocols such as the Shirley Sahrmann progression have demonstrated increased activation of key core stabilizing muscles. Emerging evidence suggests a potential relationship between core stability training and reductions in TMD-related pain, though improvements in functional outcomes remain inconclusive. Biomechanical links between the pelvic floor, spine, and temporomandibular joint further support the rationale for core-focused interventions. Nevertheless, few studies have isolated the effects of core strengthening on TMD symptomatology. This study seeks to determine whether the integration of core stability exercises into TMD management can reduce pain, improve function, and enhance quality of life.
Detailed description
This single-blinded randomized controlled trial will evaluate the effects of core strengthening exercises in addition to standard physical therapy for patients with Temporomandibular Joint Dysfunction (TMD). The study aims to determine whether integrating core stability exercises can reduce TMD-related pain, improve function, and enhance quality of life compared to standard physical therapy alone.
A total of 50 participants, aged 18-70, who have a primary complaint of TMD within the last 30 days and are willing to complete at least six physical therapy visits over a three-month period will be enrolled. Participants must speak English or have access to a verified interpreter and be able to safely participate in exercise.
Participants will be randomly assigned to one of two groups:
Group 1: Core strengthening exercises (Shirley Sahrmann progression) combined with standard TMD physical therapy, including therapeutic exercises, manual interventions, soft tissue mobilization, neuromuscular re-education, and education. Home exercise programs will support adherence.
Group 2: Standard TMD physical therapy alone, including the same therapeutic exercises, manual interventions, soft tissue mobilization, neuromuscular re-education, and education.
Key exclusion criteria include recent TMJ or spinal surgery, recent head/neck trauma or neurologic symptoms, pregnancy, concurrent physical therapy for other movement disorders, low back or pelvic health dysfunction in the past three months, use of dentures, or current chemotherapy/radiation involving the head, neck, pelvis, spine, or hip.
Participants will undergo initial evaluation, intervention sessions, and post-treatment assessment by blinded evaluating therapists to measure pain, function, and core strength outcomes. Safety will be continuously monitored throughout the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1: Core Strengthening + Standard TMD Physical Therapy | Experimental | Behavioral: Experimental: Group 1: Core Strengthening, Behavioral: Group 2: Standard TMD PTParticipants in this group will receive the Shirley Sahrmann core strengthening protocol, which involves progressive levels of dynamic movements designed to maintain a neutral spine and activate deep core muscles. Exercises begin in hook-lying or supine positions, with gradual progression through five levels, and may include upper extremity movements once core control is achieved. In addition, participants will follow a structured home exercise program with daily exercises (approximately 20 minutes), supported with printed instructions and video demonstrations through the MedBridge platform. |
| Group 2: Standard TMD Physical Therapy | Active comparator | Behavioral: Group 2: Standard TMD PTParticipants in this group will receive standard physical therapy for TMD, including: Therapeutic exercises (e.g., Rocabado 6x6) for jaw mobility and posture. Manual therapy to restore normal TMJ and cervical spine joint mechanics. Soft tissue mobilization targeting masticatory and cervical muscles as clinically indicated. Education on jaw rest position, diet/chewing modifications, and avoidance of parafunctional habits. Neuromuscular re-education to improve TMJ opening mechanics, including deep neck flexor activation and mirror training. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Experimental: Group 1: Core StrengtheningAlso: Shirley Sahrmann Core Stability ProtocolParticipants perform Shirley Sahrmann core exercises (5 progressive levels maintaining neutral spine and deep core activation), possibly adding upper extremity movements. Standard TMD PT includes jaw exercises, manual therapy, soft tissue mobilization, neuromuscular re-education, and patient education. A home exercise program (~20 min/day) is provided with printed and video instructions. | Behavioural | Group 1: Core Strengthening + Standard TMD Physical Therapy |
| Group 2: Standard TMD PTAlso: Rocabado 6x6 ExercisesParticipants receive standard TMD PT including jaw exercises (Rocabado 6x6), manual therapy for TMJ and cervical spine, soft tissue mobilization, neuromuscular re-education to improve jaw mechanics, and education on jaw positioning, diet/chewing modifications, and parafunctional habits. A home exercise program is provided as part of treatment. | Behavioural | Group 1: Core Strengthening + Standard TMD Physical Therapy, Group 2: Standard TMD Physical Therapy |
Primary outcome
TMD Pain (e.g., Visual Analog Scale/Numeric Pain Rating)
Time frame: Baseline and post-intervention (6 PT sessions), assessed up to 6 weeks
3 secondary outcomes
Neck Disability Index (NDI)
Time frame: Baseline and post-intervention (6 PT sessions), assessed up to 6 weeks
Compliance with Home Exercise Program (HEP)
Time frame: Throughout the 6-week intervention period (daily tracking, summarized at post-intervention)
Functional Measures from TMJ Scale
Time frame: Baseline and post-intervention (6 PT sessions), assessed up to 6 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2025.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental: Group 1: Core Strengthening and Group 2: Standard TMD PT in people with Temporomandibular Joint Dysfunction and TMD, run by Loyola University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: opening soon, as of the sponsor's last update on 10 Nov 2025. 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 United States. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
TMD Pain (e.g., Visual Analog Scale/Numeric Pain Rating) (time frame: Baseline and post-intervention (6 PT sessions), assessed up to 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Nov 2025.