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CTRI Number  CTRI/2025/09/094829 [Registered on: 16/09/2025] Trial Registered Prospectively
Last Modified On: 15/09/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Effectiveness of LASER Therapy Alone Versus in Combination with Manual Drainage Techniques for Sinusitis 
Scientific Title of Study   Effect of LASER Therapy Vs LASER Therapy combined with Manual Drainage Techniques for the Management of Sinusitis- An Experimental Study. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
Nil  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Gunpreet Kaur 
Designation  Assistant Professor  
Affiliation  Chitkara University  
Address  Department of Physiotherapy, Chitkara University, Punjab, India
Department of Physiotherapy, Chitkara University, Punjab, India
Patiala
PUNJAB
140401
India 
Phone  6239184902  
Fax    
Email  gunpreet.kaur@chitkara.edu.in  
 
Details of Contact Person
Scientific Query  
Name  Harneet Kaur  
Designation  PG student 
Affiliation  Chitkara University  
Address  Department of Physiotherapy, Chitkara University, Punjab, India
Department of Physiotherapy, Chitkara University, Punjab, India
Patiala
PUNJAB
140401
India 
Phone  8196057450  
Fax    
Email  harneet.1058@chitkara.edu.in   
 
Details of Contact Person
Public Query  
Name  Harneet Kaur  
Designation  PG student 
Affiliation  Chitkara University  
Address  Department of Physiotherapy, Chitkara University, Punjab, India
Department of Physiotherapy, Chitkara University, Punjab, India
Patiala
PUNJAB
140401
India 
Phone  8196057450  
Fax    
Email  harneet.1058@chitkara.edu.in   
 
Source of Monetary or Material Support  
nil 
OPD of Physiotherapy Department, Chitkara University, Punjab,Pin code:140401 ,India  
 
Primary Sponsor  
Name  Nil 
Address  Nil 
Type of Sponsor  Other [Nil] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Harneet kaur PT  Chitkara University  Chitkara University, Punjab Campus Chandigarh-Patiala National Highway (NH-64) Punjab – 140 401, India
Patiala
PUNJAB 		 8196057450

harneet.1058@chitkara.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL HUMAN ETHICAL COMMITTEE CHITKARA UNIVERSITY, PUNJAB  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J320||Chronic maxillary sinusitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  LASER THERAPY  The area of LLLT application will be skin over the cheeks Contact technique will be used with patient wearing safety goggles in supine lying position The laser beam will be kept stationary and perpendicular to skin. Laser irradiation will be delivered in continuous –wave mode DOSAGE: Wavelength:830nm, average power output :30mW, energy dose:1 J Duration: 3 weeks (3 times a week) total 9 sessions  
Intervention  LASER THERAPY + MANUAL DRAINAGE  : The area of LLLT application will be skin over the cheeks Contact technique will be used with patient wearing safety goggles in supine lying position The laser beam will be kept stationary and perpendicular to skin. Laser irradiation will be delivered in continuous –wave mode DOSAGE: Wavelength:830nm, average power output :30mW, energy dose:1 J For Manual drainage: Therapist will use thumb to provide gradual increasing and released pressure down to maxillary sinuses in a smooth rhythmic motion  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  1. Individuals aged between 18-50 years
2. Individuals having sinusitis
 
 
ExclusionCriteria 
Details  1. Patients with any tumours or cysts (in or around face)
2. Patients with nasal polyps.
3. Patients having facial metal implants.
4. Patients with allergies on the face.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Sino-Nasal Outcome Test-22 Questionnaire (SNOT).  baseline & 6 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   26/09/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  26/09/2025 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Sinusitis is a common condition characterized by inflammation of the paranasal sinuses, resulting in nasal obstruction, pain, headache, and a reduced quality of life. Conventional management often involves antibiotics, decongestants, or steroids, but these can have side effects and may not prevent recurrence. Low-level laser therapy (LLLT) has shown potential to reduce inflammation, improve drainage, and enhance tissue repair. Manual drainage techniques (MDT) help improve lymphatic flow, relieve congestion, and ease sinus pressure.This experimental study will compare the effectiveness of LLLT alone with LLLT combined with manual drainage techniques in patients with sinusitis. A total of 60 participants aged 18–50 years will be recruited and randomly assigned into two groups. Group A will receive LLLT, while Group B will receive LLLT along with manual drainage. Each group will undergo nine sessions over three weeks. The primary outcome will be symptom improvement measured using the Sino-Nasal Outcome Test-22 (SNOT-22).The study aims to determine whether adding manual drainage to laser therapy provides superior relief and functional recovery compared to laser therapy alone. The findings may support evidence-based guidelines for non-invasive physiotherapy management of sinusitis.

 
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