Photobiomodulation and Sonophoresis Improving Jaw Mobility and Quality of Life Among Head and Neck Cancer Survivors
Primary Purpose
Head and Neck Cancer, Trismus
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Photobiomodulation therapy with mandibular exercises
Sonophoresis with mandibular exercises
Sponsored by
About this trial
This is an interventional treatment trial for Head and Neck Cancer focused on measuring Electrotherapy, Photobiomodulation, Quality of life
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Photobiomodulation group
Sonophoresis group
Arm Description
Low-level laser therapy will be given to the PTMB group along with mandibular mobilization and stabilization exercises
Ultrasonic massage with diclofenac gel will be given to the sonophoresis group along with mandibular mobilization and stabilization exercises
Outcomes
Primary Outcome Measures
Algometer
Algometer is a digital calibrated outcome measure, measures the pain pressure threshold.
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.
Secondary Outcome Measures
Digital Vernier calliper
Digital Vernier calliper measures the range of motion of mandibular mobility
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04082793
Brief Title
Photobiomodulation and Sonophoresis Improving Jaw Mobility and Quality of Life Among Head and Neck Cancer Survivors
Official Title
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.
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Unknown status
Study Start Date
June 1, 2020 (Anticipated)
Primary Completion Date
March 31, 2021 (Anticipated)
Study Completion Date
May 31, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Asir John Samuel
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Cancer, Trismus
Keywords
Electrotherapy, Photobiomodulation, Quality of life
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Parallel assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Masking Description
Participants, outcome assessors and care provider will be blinded in the study. This will be a triple blinded randomized controlled trial
Allocation
Randomized
Enrollment
48 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Photobiomodulation group
Arm Type
Experimental
Arm Description
Low-level laser therapy will be given to the PTMB group along with mandibular mobilization and stabilization exercises
Arm Title
Sonophoresis group
Arm Type
Experimental
Arm Description
Ultrasonic massage with diclofenac gel will be given to the sonophoresis group along with mandibular mobilization and stabilization exercises
Intervention Type
Combination Product
Intervention Name(s)
Photobiomodulation therapy with mandibular exercises
Other Intervention Name(s)
Low-level laser therapy
Intervention Description
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
Intervention Type
Combination Product
Intervention Name(s)
Sonophoresis with mandibular exercises
Other Intervention Name(s)
Ultrasonic massage with diclofenac gel
Intervention Description
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
Primary Outcome Measure Information:
Title
Algometer
Description
Algometer is a digital calibrated outcome measure, measures the pain pressure threshold.
Time Frame
Change from baseline, 2 weeks after intervention and at the end of 4th week will be measured.
Title
Core measure Questionnaire-C30 (QLQ-C30)
Description
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.
Time Frame
Change from baseline, 2 weeks after intervention and at the end of 4th week will be measured.
Secondary Outcome Measure Information:
Title
Digital Vernier calliper
Description
Digital Vernier calliper measures the range of motion of mandibular mobility
Time Frame
Change from baseline, 2 weeks after intervention and at the end of 4th week will be measured.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Asir J Samuel, MPT, (PhD)
Phone
8059930222
Email
asirjohnsamuel@mmumullana.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Neha Sharma, MPT
Organizational Affiliation
Maharishi Markandeshwar institute of Physiotherapy and Rehabilitation
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
22884841
Citation
Gautam AP, Fernandes DJ, Vidyasagar MS, Maiya AG, Vadhiraja BM. Low level laser therapy for concurrent chemoradiotherapy induced oral mucositis in head and neck cancer patients - a triple blinded randomized controlled trial. Radiother Oncol. 2012 Sep;104(3):349-54. doi: 10.1016/j.radonc.2012.06.011. Epub 2012 Aug 10.
Results Reference
background
PubMed Identifier
26984249
Citation
Zecha JA, Raber-Durlacher JE, Nair RG, Epstein JB, Elad S, Hamblin MR, Barasch A, Migliorati CA, Milstein DM, Genot MT, Lansaat L, van der Brink R, Arnabat-Dominguez J, van der Molen L, Jacobi I, van Diessen J, de Lange J, Smeele LE, Schubert MM, Bensadoun RJ. Low-level laser therapy/photobiomodulation in the management of side effects of chemoradiation therapy in head and neck cancer: part 2: proposed applications and treatment protocols. Support Care Cancer. 2016 Jun;24(6):2793-805. doi: 10.1007/s00520-016-3153-y. Epub 2016 Mar 17.
Results Reference
background
PubMed Identifier
9481998
Citation
Shin SM, Choi JK. Effect of indomethacin phonophoresis on the relief of temporomandibular joint pain. Cranio. 1997 Oct;15(4):345-8. doi: 10.1080/08869634.1997.11746030.
Results Reference
background
PubMed Identifier
23640558
Citation
Samuel SR, Maiya GA, Babu AS, Vidyasagar MS. Effect of exercise training on functional capacity & quality of life in head & neck cancer patients receiving chemoradiotherapy. Indian J Med Res. 2013 Mar;137(3):515-20.
Results Reference
background
PubMed Identifier
30919154
Citation
Samuel SR, Maiya AG, Fernandes DJ, Guddattu V, Saxena PUP, Kurian JR, Lin PJ, Mustian KM. Effectiveness of exercise-based rehabilitation on functional capacity and quality of life in head and neck cancer patients receiving chemo-radiotherapy. Support Care Cancer. 2019 Oct;27(10):3913-3920. doi: 10.1007/s00520-019-04750-z. Epub 2019 Mar 27.
Results Reference
background
Links:
URL
https://link.springer.com/article/10.1007%2Fs00520-019-04750-z
Description
Effectiveness of exercise-based rehabilitation on functional capacity and quality of life in head and neck cancer patients receiving chemo-radiotherapy
Learn more about this trial
Photobiomodulation and Sonophoresis Improving Jaw Mobility and Quality of Life Among Head and Neck Cancer Survivors
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