Photobiomodulation and Sonophoresis Improving Jaw Mobility and Quality of Life Among Head and Neck Cancer Survivors

Study Overview
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Brief Summary
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Head and neck cancer originate from the several different anatomical subsites especially the squamous cell carcinoma. This involves mainly Oropharynx, Hypopharynx, and Larynx. The common treatment approaches for HNC is radiation therapy, alone or combined with chemotherapy and surgery. In the present scenario, very little literature is available improving the QOL by physiotherapeutic measures in patients with HNC. To improve QOL, a well-designed study is needed. The study will be a two-group pretest-posttest design. The study will include patients with HNC receiving radiation or chemotherapy. One group will receive photobiomodulation therapy and another group will receive Sonophoresis. Both the group will receive Mandibular mobilization and stabilization exercises after electrotherapy. The Algometer, Digital Vernier caliper and core measure Questionnaire-C30 (QLQ-C30) will be used as an outcome measure to measure the effect of interventions between baseline and post-interventions.

Detailed Description
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The trial will include two experimental groups. The study design will be two groups pretest-posttest design. The study will recruit patients with HNC receiving radiation or chemotherapy. The study will be conducted in Tertiary care teaching hospital, in the departments of Radiotherapy and physiotherapy of Maharishi Markandeshwar Hospital, Maharishi Markandeshwar Deemed to be University, Mullana, Ambala. Total of 48 patients will be recruited in the study. Patients will be randomized by block randomization method into two groups. One group will receive Photobiomodulation therapy whereas another group will receive Sonophoresis. Mandibular mobilization and stabilization exercises will be given to both groups. The intervention will be given for 4 weeks. Three sessions of photobiomodulation therapy will be given per week on alternating days for 12 minutes, whereas three sessions of sonophoresis will also be given per week on alternating days for 8 minutes. Mandibular mobilization, as well as stabilization exercises, will be advised to perform regularly continuously for 4 weeks. There will be blinding of patients who will receive the therapy, therapist who will administer the therapy, and therapist who will assess the patients, therefore, the study will follow triple blinding.Algometer for pain measurement, Digital vernier caliper for measuring mandibular mobility and Core measure Questionnaire-C30 (QLQ-C30) for measuring the quality of life in patients with head and neck cancer will be taken as outcome measures. The outcomes will be taken before giving intervention, then again after 2 weeks of interventions and again on another 2 weeks of intervention.

Official Title
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Comparison of Photobiomodulation Therapy and Sonophoresis in Improving Tempomandibular Joint Mobility and Quality of Life Among Head and Neck Cancer Survivors (PBMT-S Trial): A Triple-Blind, Randomized Controlled Trial.

Conditions
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Head and Neck Cancer, Trismus

Intervention / Treatment
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* Combination Product: Photobiomodulation therapy with mandibular exercises
* Combination Product: Sonophoresis with mandibular exercises


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with Clinical diagnosis of HNC undergoing chemo and radiation therapy Patient having joint pain and stiffness following chemo and radiation therapy Patients with the age group of 18 - 70 years Exclusion Criteria: Patients with Mandibular reconstruction surgery Patients with platelet count <80,000/µl of blood and haemoglobin count <8g/dl Patients with cervical spine dysfunction and nerve damage Patients who is not willing to participate in the study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Parallel assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Photobiomodulation group<br>Low-level laser therapy will be given to the PTMB group along with mandibular mobilization and stabilization exercises | Combination Product: Photobiomodulation therapy with mandibular exercises<br>* Low-level laser therapy (BMI 1005 Laser 2200) Wavelength: 658 nm Power: 100 MW Energy density: 4J/cm2 Dose administered: 4J Mode: Pulsed Site of application: Over bilateral Temporomandibular joint Number of sessions: 3 sessions/week on alternating days for 12 minutes each, for 4 weeks Mandibular mobilization exercises Side to side movement of the jaw Forward jaw movement Tongue up Goldfish exercise (Partial opening) Goldfish exercise (Full opening) Exercise duration: 6 repetitions X 2 sets X 4 times a day Mandibular Stabilization exercises Exercise duration: 5 repetitions X 3 sec. Hold X 4 times a day<br>* Other names: Low-level laser therapy;Combination Product: Sonophoresis with mandibular exercises<br>* Ultrasound (BM1-1039) Ultrasonic massage with Diclofenac gel Frequency: 1.0 MHz Mode: Continuous Intensity: 0.8 to 1.5 W/cm2 Site of application: Over bilateral Temporomandibular joint Number of sessions: 3 sessions per week on alternating days for 8 minutes each, for 4 weeks Mandibular mobilization exercises Side to side movement Forward jaw movement Tongue up Goldfish exercise (Partial opening) Goldfish exercise (Full opening) Exercise duration: 6 repetition X 2 sets X 4 times a day Mandibular Stabilization exercises Exercise duration: 5 repetitions X 3 sec. Hold X 4 times a day<br>* Other names: Ultrasonic massage with diclofenac gel;|
| Experimental: Sonophoresis group<br>Ultrasonic massage with diclofenac gel will be given to the sonophoresis group along with mandibular mobilization and stabilization exercises | Combination Product: Photobiomodulation therapy with mandibular exercises<br>* Low-level laser therapy (BMI 1005 Laser 2200) Wavelength: 658 nm Power: 100 MW Energy density: 4J/cm2 Dose administered: 4J Mode: Pulsed Site of application: Over bilateral Temporomandibular joint Number of sessions: 3 sessions/week on alternating days for 12 minutes each, for 4 weeks Mandibular mobilization exercises Side to side movement of the jaw Forward jaw movement Tongue up Goldfish exercise (Partial opening) Goldfish exercise (Full opening) Exercise duration: 6 repetitions X 2 sets X 4 times a day Mandibular Stabilization exercises Exercise duration: 5 repetitions X 3 sec. Hold X 4 times a day<br>* Other names: Low-level laser therapy;Combination Product: Sonophoresis with mandibular exercises<br>* Ultrasound (BM1-1039) Ultrasonic massage with Diclofenac gel Frequency: 1.0 MHz Mode: Continuous Intensity: 0.8 to 1.5 W/cm2 Site of application: Over bilateral Temporomandibular joint Number of sessions: 3 sessions per week on alternating days for 8 minutes each, for 4 weeks Mandibular mobilization exercises Side to side movement Forward jaw movement Tongue up Goldfish exercise (Partial opening) Goldfish exercise (Full opening) Exercise duration: 6 repetition X 2 sets X 4 times a day Mandibular Stabilization exercises Exercise duration: 5 repetitions X 3 sec. Hold X 4 times a day<br>* Other names: Ultrasonic massage with diclofenac gel;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Algometer | Algometer is a digital calibrated outcome measure, measures the pain pressure threshold. | Change from baseline, 2 weeks after intervention and at the end of 4th week will be measured. | 
| Core measure Questionnaire-C30 (QLQ-C30) | The questionnaire are designed to measure physical, social and psychological functions of patients with cancer. The questionnaire contains physical, social, emotional and cognitive functioning multi item scales and 9 single items. These items are pain, fatigue, financial impact, appetite loss, nausea and vomiting, diarrhea, constipation, sleep disturbance and quality of life. All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. Time required for administration is 10 to 15 minutes. | Change from baseline, 2 weeks after intervention and at the end of 4th week will be measured. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Digital Vernier calliper | Digital Vernier calliper measures the range of motion of mandibular mobility | Change from baseline, 2 weeks after intervention and at the end of 4th week will be measured. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Electrotherapy, Photobiomodulation, Quality of life