Evaluation of the Synergistic Effects of Integrative PhysiOsteopathic Therapy Combined with Low-Level Laser Therapy (LLLT) on Pain Reduction, Functional Improvement, Psychological Well-being, and Quality of Life in Patients with Temporomandibular Disorders (TMD): A Randomized Controlled Trial
Overview
- Phase
- Phase 1/2
- Status
- Not yet recruiting
- Sponsor
- Dr Ramesh Chandra Patra
- Enrollment
- 165
- Locations
- 1
- Primary Endpoint
- The primary outcomes of this study will focus on three key domains: pain intensity, jaw functionality, and quality of life. Pain intensity will be assessed using both the Visual Analog Scale (VAS) and the Numeric Rating Scale (NRS), each ranging from 0 (no pain) to 10 (worst possible pain), providing a quantitative measure of the patient’s subjective pain experience. Jaw functionality will be evaluated through Maximum Mouth Opening (MMO) measured in millimeters, as well as the Jaw Functional Limitation Scale (JFLS), a patient-reported questionnaire assessing limitations in activities such as chewing, speaking, and yawning. Quality of life will be measured using the Oral Health Impact Profile-14 (OHIP-14), which captures the impact of temporomandibular disorder symptoms on daily activities, psychosocial well-being, and overall oral health-related quality of life.
Overview
Brief Summary
This study is a randomized controlled trial designed to evaluate the effectiveness of combined Integrative PhysiOsteopathic Therapy and Low-Level Laser Therapy in patients with temporomandibular disorders. The study will include adults aged 18 to 65 years diagnosed with TMD who experience moderate to severe pain and functional limitation. Participants will be randomly assigned to one of three groups: the intervention group receiving physiosteopathic therapy plus low-level laser therapy, a control group receiving sham therapy, and an optional standard care group receiving conventional physiotherapy. The primary outcomes will include pain intensity measured using the visual analog scale and numeric rating scale, jaw functionality assessed with maximum mouth opening and the jaw functional limitation scale, and quality of life measured by the oral health impact profile 14. Secondary outcomes will include psychological well-being assessed with the Beck Depression Inventory and State Trait Anxiety Inventory, global perceived effect, and optional electromyographic activity of jaw muscles. The study aims to determine whether the combined therapy provides superior improvement in pain, function, and quality of life compared to sham or standard care.
Study Design
- Study Type
- Interventional
- Allocation
- Coin toss, Lottery, toss of dice, shuffling cards etc
- Masking
- Participant and Outcome Assessor Blinded
Eligibility Criteria
- Ages
- 20.00 Year(s) to 50.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Participants eligible for this study must have a confirmed diagnosis of temporomandibular disorder (TMD) according to the Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD), verified by a qualified clinician.
- •Eligible individuals must report subjective pain in the temporomandibular joint and/or masticatory muscles of at least 4 on the Visual Analog Scale (VAS) on a 0 to 10 scale at baseline.
- •Additionally, participants must exhibit functional impairment, such as reduced maximum mouth opening or difficulty chewing, demonstrating the clinical impact of the disorder.
- •Only those with a chronic condition, defined as symptoms persisting for at least three months, will be included.
- •Finally, participants must have the ability and willingness to provide written informed consent and comply with all study procedures.
Exclusion Criteria
- •Previous TMJ Surgery History of surgical intervention on the temporomandibular joint.
- •Systemic Rheumatologic or Autoimmune Disorders Conditions such as rheumatoid arthritis, systemic lupus erythematosus, or ankylosing spondylitis affecting the craniofacial or musculoskeletal system.
- •Neurological Disorders Neuropathies, trigeminal neuralgia, multiple sclerosis, or other central/peripheral nervous system disorders affecting craniofacial function.
- •Active Malignancy Active cancer in the craniofacial region or systemic malignancies.
- •Pregnancy or Breastfeeding Due to unknown effects of LLLT on pregnancy and developing fetus.
- •Photosensitivity Disorders History of conditions like lupus or porphyria making the patient sensitive to light-based therapies.
- •Current Use of Muscle Relaxants or Analgesics (Unstable Regimen) Patients who have changed or plan to change medication within 1 month of study entry.
- •Severe Psychiatric Illness Active major depression, psychosis, or inability to cooperate with the study protocol.
- •Infection or Skin Lesion in Treatment Area Active infection, open wounds, or dermatitis in the TMJ or surrounding areas.
Outcomes
Primary Outcomes
The primary outcomes of this study will focus on three key domains: pain intensity, jaw functionality, and quality of life. Pain intensity will be assessed using both the Visual Analog Scale (VAS) and the Numeric Rating Scale (NRS), each ranging from 0 (no pain) to 10 (worst possible pain), providing a quantitative measure of the patient’s subjective pain experience. Jaw functionality will be evaluated through Maximum Mouth Opening (MMO) measured in millimeters, as well as the Jaw Functional Limitation Scale (JFLS), a patient-reported questionnaire assessing limitations in activities such as chewing, speaking, and yawning. Quality of life will be measured using the Oral Health Impact Profile-14 (OHIP-14), which captures the impact of temporomandibular disorder symptoms on daily activities, psychosocial well-being, and overall oral health-related quality of life.
Time Frame: Baseline, 4 weeks, and 3 months
Secondary Outcomes
- secondary outcomes will be assessed to evaluate the broader impact of the intervention. Psychological well-being will be measured using the Beck Depression Inventory (BDI) to assess depressive symptoms and the State-Trait Anxiety Inventory (STAI) to capture both temporary and long-standing anxiety levels. Patient-perceived overall improvement will be recorded using the Global Perceived Effect (GPE) scale. Optionally, electromyographic (EMG) activity of the jaw muscles may be measured to provide objective data on neuromuscular function and muscle activity patterns before and after the intervention. Collectively, these primary and secondary outcomes will allow a comprehensive evaluation of the therapeutic effects of the combined Integrative PhysiOsteopathic Therapy and Low-Level Laser Therapy on patients with temporomandibular disorders.(Baseline, 4 weeks, and 3 months)
Investigators
Dr Ramesh Chandra Patra
Lovely Professional University Faculty of Applied Medical Sciences