| CTRI Number |
CTRI/2025/09/094836 [Registered on: 16/09/2025] Trial Registered Prospectively |
| Last Modified On: |
16/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparing LASER Therapy and Ultrasound Treatment for Chronic Neck Pain Relief |
|
Scientific Title of Study
|
Efficacy of LASER Therapy and Therapeutic Ultrasound in the Management of Chronic Neck Pain |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Roopika Sabharwal |
| Designation |
Assistant Professor |
| Affiliation |
Chitkara University |
| Address |
Department of Physiotherapy , Chitkara School of Health Sciences, Chitkara University, PUNJAB , INDIA
Chitkara University, Punjab, Chandigarh-Patiala National Highway (NH-64), Punjab – 140 401, India
Patiala
PUNJAB
140401
India |
| Phone |
8427021055 |
| Fax |
|
| Email |
roopika.sabharwal@chitkara.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
AMANDEEP SINGH BEDI |
| Designation |
PG Student |
| Affiliation |
Chitkara University |
| Address |
Department of Physiotherapy , Chitkara School of Health Sciences, Chitkara University, PUNJAB , INDIA
Chitkara University, Punjab, Chandigarh-Patiala National Highway (NH-64), Punjab – 140 401, India
Patiala
PUNJAB
140401
India |
| Phone |
9988055827 |
| Fax |
|
| Email |
amandeep.3261@chitkara.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
AMANDEEP SINGH BEDI |
| Designation |
PG Student |
| Affiliation |
Chitkara University |
| Address |
Department of Physiotherapy , Chitkara School of Health Sciences, Chitkara University, PUNJAB , INDIA
Chitkara University, Punjab, Chandigarh-Patiala National Highway (NH-64), Punjab – 140 401, India
PUNJAB
140401
India |
| Phone |
9988055827 |
| Fax |
|
| Email |
amandeep.3261@chitkara.edu.in |
|
|
Source of Monetary or Material Support
|
| NIL |
| OPD of Department of Physiotherapy Chitkara University Punjab 140401 |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [NIL] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr AMANDEEP SINGH BEDI PT |
Chitkara University,Punjab -140401 |
OPD of department of Physiotherapy, Room no.004 Chitkara University, Punjab, Chandigarh-Patiala National Highway (NH-64), Punjab – 140401, India
Patiala
PUNJAB |
9988055827
amandeep.3261@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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M542||Cervicalgia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Exercise only |
Participants will receive only the exercise program, including:
1.Cervical isometrics
2.Deep neck flexor strengthening
3.Stretching of upper trapezius, levator scapulae, and pectorals
4.Proprioceptive and postural correction exercises
|
| Intervention |
LASER Therapy + Exercise |
LASER parameters:
1.Type: Low-Level LASER (Class 3B)
2.Wavelength: 808–830 nm
3.Energy density: 4–8 J/cm² per point
4.Duration: 30–60 seconds per point on trigger points
• Followed by the same conventional cervical exercise program |
| Intervention |
Therapeutic Ultrasound + Excersie |
Ultrasound parameters:
1.Frequency: 1 MHz
2.Intensity: 1.0–1.5 W/cm² (continuous mode)
3.Duration: 7–8 minutes over the cervical paraspinal muscles
• Followed by the same conventional cervical exercise program |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Adults aged between 18–60 years
Diagnosis of neck pain lasting for more than 12 weeks
NPRS pain intensity ranging between 4–10
Moderate disability as determined by NDI scores (score above 25)
Willingness to participate voluntarily and comply with the treatment protocol
|
|
| ExclusionCriteria |
| Details |
• Recent cervical trauma within the last 3 months
• Presence of neurological symptoms (e.g., radiculopathy, numbness, weakness)
• History of cervical spine surgery or known structural abnormalities
• Diagnosed autoimmune, systemic, or malignant conditions affecting the cervical region
• Taking medicines for pain and inflammation
• Pregnant or lactating women
• Known contraindications for LASER or ultrasound therapy (e.g., epilepsy, pacemakers, photosensitivity)
• Individuals with cognitive impairments that interfere with understanding or adherence to the intervention
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Pain Intensity
NPRS pain scale
|
Baseline, 6weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="99"
Sample Size from India="99"
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)
|
27/09/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
27/09/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
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
|
Chronic neck pain is a common musculoskeletal disorder that leads to functional limitation and reduced quality of life. It is most often associated with poor posture, prolonged computer use, stress, and degenerative changes. Physiotherapy interventions are considered important in conservative management. Among these, physical agents such as Low Level Laser Therapy and Therapeutic Ultrasound are frequently used to reduce pain and improve mobility.This randomized controlled trial is designed to compare the effectiveness of Low Level Laser Therapy and Therapeutic Ultrasound, each combined with exercise therapy, in patients with chronic neck pain. A total of 60 participants aged between 18 and 50 years will be randomly allocated into two groups. Group A will receive Laser therapy with exercise and Group B will receive Ultrasound therapy with exercise. Treatment will be given for three weeks with three sessions per week.The primary outcome measure will be pain intensity assessed by Visual Analogue Scale. Secondary outcomes will include Neck Disability Index and cervical range of motion. The study aims to determine which modality provides superior clinical benefits when combined with exercise for the management of chronic neck pain. |