Ignite Creation Date:
2025-12-25 @ 3:26 AM
Ignite Modification Date:
2025-12-26 @ 2:06 AM
Study NCT ID:
NCT07226505
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-11-10
First Post:
2025-10-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effects of Core Strengthening Exercises for Treating TMD
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013705', 'term': 'Temporomandibular Joint Disorders'}], 'ancestors': [{'id': 'D017271', 'term': 'Craniomandibular Disorders'}, {'id': 'D008336', 'term': 'Mandibular Diseases'}, {'id': 'D007571', 'term': 'Jaw Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'Single-blinded (evaluating PT blinded)'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-11-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2027-01-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-07', 'studyFirstSubmitDate': '2025-10-30', 'studyFirstSubmitQcDate': '2025-11-07', 'lastUpdatePostDateStruct': {'date': '2025-11-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-11-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'TMD Pain (e.g., Visual Analog Scale/Numeric Pain Rating)', 'timeFrame': 'Baseline and post-intervention (6 PT sessions), assessed up to 6 weeks'}], 'secondaryOutcomes': [{'measure': 'Neck Disability Index (NDI)', 'timeFrame': 'Baseline and post-intervention (6 PT sessions), assessed up to 6 weeks', 'description': "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."}, {'measure': 'Compliance with Home Exercise Program (HEP)', 'timeFrame': 'Throughout the 6-week intervention period (daily tracking, summarized at post-intervention)', 'description': 'Assessed via participant-completed exercise diaries, tracking adherence to prescribed daily exercises.'}, {'measure': 'Functional Measures from TMJ Scale', 'timeFrame': 'Baseline and post-intervention (6 PT sessions), assessed up to 6 weeks', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Core strengthening', 'physical therapy', 'RCT'], 'conditions': ['Temporomandibular Joint Dysfunction', 'TMD', 'TMJ Internal Derangement', 'Myofascial Pain']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nA 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.\n\nParticipants will be randomly assigned to one of two groups:\n\nGroup 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.\n\nGroup 2: Standard TMD physical therapy alone, including the same therapeutic exercises, manual interventions, soft tissue mobilization, neuromuscular re-education, and education.\n\nKey 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.\n\nParticipants 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Who Can Participate (Inclusion Criteria):\n\nAdults between 18 and 70 years old.\n\nHave had jaw pain or problems with the jaw joint (TMD) in the last 30 days.\n\nAble and willing to attend at least six physical therapy sessions over three months.\n\nSpeak English or have access to a qualified interpreter.\n\nAble to safely do physical exercises.\n\nWho Cannot Participate (Exclusion Criteria):\n\nRecently had surgery on the jaw, teeth, or spine (within the last 3 months).\n\nRecently had head or neck injuries or certain neurological problems (such as dizziness, double vision, trouble swallowing, or sudden falls).\n\nAre pregnant or become pregnant during the study.\n\nCurrently doing physical therapy for other movement problems that could affect the study.\n\nHave had lower back or pelvic health issues in the last 3 months.\n\nCurrently receiving chemotherapy or radiation for cancer in the head, neck, pelvis, spine, or hip.\n\nWear dentures or cannot safely perform exercises.'}, 'identificationModule': {'nctId': 'NCT07226505', 'briefTitle': 'Effects of Core Strengthening Exercises for Treating TMD', 'organization': {'class': 'OTHER', 'fullName': 'Loyola University'}, 'officialTitle': 'A Randomized Trial Analyzing the Effects of Core Strengthening Exercises in Physical Therapy for Treating Temporomandibular Joint Dysfunction', 'orgStudyIdInfo': {'id': '219911'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group 1: Core Strengthening + Standard TMD Physical Therapy', 'description': '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.', 'interventionNames': ['Behavioral: Experimental: Group 1: Core Strengthening', 'Behavioral: Group 2: Standard TMD PT']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group 2: Standard TMD Physical Therapy', 'description': 'Participants in this group will receive standard physical therapy for TMD, including:\n\nTherapeutic exercises (e.g., Rocabado 6x6) for jaw mobility and posture.\n\nManual therapy to restore normal TMJ and cervical spine joint mechanics.\n\nSoft tissue mobilization targeting masticatory and cervical muscles as clinically indicated.\n\nEducation on jaw rest position, diet/chewing modifications, and avoidance of parafunctional habits.\n\nNeuromuscular re-education to improve TMJ opening mechanics, including deep neck flexor activation and mirror training.', 'interventionNames': ['Behavioral: Group 2: Standard TMD PT']}], 'interventions': [{'name': 'Experimental: Group 1: Core Strengthening', 'type': 'BEHAVIORAL', 'otherNames': ['Shirley Sahrmann Core Stability Protocol'], 'description': '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.', 'armGroupLabels': ['Group 1: Core Strengthening + Standard TMD Physical Therapy']}, {'name': 'Group 2: Standard TMD PT', 'type': 'BEHAVIORAL', 'otherNames': ['Rocabado 6x6 Exercises'], 'description': '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.', 'armGroupLabels': ['Group 1: Core Strengthening + Standard TMD Physical Therapy', 'Group 2: Standard TMD Physical Therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60153', 'city': 'Maywood', 'state': 'Illinois', 'country': 'United States', 'contacts': [{'name': 'Dr. Margaret Miller, MD', 'role': 'CONTACT', 'email': 'Margaret.Miller001@luhs.org', 'phone': '(888) 584-7888'}, {'name': 'Dr. Margaret Miller, MD', 'role': 'CONTACT', 'email': 'Margaret.Miller001@luhs.org'}], 'facility': 'Loyola University Medical Center', 'geoPoint': {'lat': 41.8792, 'lon': -87.84312}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Loyola University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Loyola University Chicago', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Margaret Miller', 'investigatorAffiliation': 'Loyola University Chicago'}}}}