- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07226505
Effects of Core Strengthening Exercises for Treating TMD
A Randomized Trial Analyzing the Effects of Core Strengthening Exercises in Physical Therapy for Treating Temporomandibular Joint Dysfunction
Study Overview
Status
Intervention / Treatment
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Illinois
-
Maywood, Illinois, United States, 60153
- Loyola University Medical Center
-
Contact:
- Dr. Margaret Miller, MD
- Phone Number: (888) 584-7888
- Email: Margaret.Miller001@luhs.org
-
Contact:
- Dr. Margaret Miller, MD
- Email: Margaret.Miller001@luhs.org
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Group 1: Core Strengthening + Standard TMD Physical Therapy
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.
|
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.
Other Names:
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.
Other Names:
|
|
Active Comparator: Group 2: Standard TMD Physical Therapy
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. |
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
TMD Pain (e.g., Visual Analog Scale/Numeric Pain Rating)
Time Frame: Baseline and post-intervention (6 PT sessions), assessed up to 6 weeks
|
Baseline and post-intervention (6 PT sessions), assessed up to 6 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Neck Disability Index (NDI)
Time Frame: Baseline and post-intervention (6 PT sessions), assessed up to 6 weeks
|
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.
|
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)
|
Assessed via participant-completed exercise diaries, tracking adherence to prescribed daily exercises.
|
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
|
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.
|
Baseline and post-intervention (6 PT sessions), assessed up to 6 weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 219911
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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