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

Asir John Samuel

Status: Unknown

Conditions: Trismus; Head and Neck Cancer

Treatments: Combination Product: Photobiomodulation therapy with mandibular exercises; Combination Product: Sonophoresis with mandibular exercises

Study type: Interventional

Funder types: Other

Identifiers

NCT04082793

MMDU/2019/02

U1111-1235-0005 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 48 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

48 participants in 2 patient groups

Photobiomodulation group

Experimental group

Description:

Low-level laser therapy will be given to the PTMB group along with mandibular mobilization and stabilization exercises

Treatment:

Combination Product: Sonophoresis with mandibular exercises

Combination Product: Photobiomodulation therapy with mandibular exercises

Sonophoresis group

Experimental group

Description:

Ultrasonic massage with diclofenac gel will be given to the sonophoresis group along with mandibular mobilization and stabilization exercises

Treatment:

Combination Product: Sonophoresis with mandibular exercises

Combination Product: Photobiomodulation therapy with mandibular exercises