search
Back to results

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
Asir John Samuel
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Head and Neck Cancer focused on measuring Electrotherapy, Photobiomodulation, Quality of life

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

    First Posted
    August 31, 2019
    Last Updated
    March 6, 2020
    Sponsor
    Asir John Samuel
    search

    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

    We'll reach out to this number within 24 hrs