| CTRI Number |
CTRI/2025/06/089823 [Registered on: 30/06/2025] Trial Registered Prospectively |
| Last Modified On: |
29/06/2025 |
| 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
|
A study to find out if different types of physiotherapy can reduce pain and improve walking in people with neck pain |
|
Scientific Title of Study
|
Efficacy of Multimodal Physiotherapy on Pain, Joint Position Sense and Gait in Patients With Neck Pain: A Randomized Controlled Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Bhoomika Bhat |
| Designation |
Post Graduate Student |
| Affiliation |
Nitte Institute of Physiotherapy |
| Address |
Nitte Institute of Physiotherapy,
NITTE (DU), P.O 12. Deralkatte, Mangalore - 575018
Karnataka, India
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
7975609616 |
| Fax |
|
| Email |
bhoomikabhat77@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Mr Nityal Kumar |
| Designation |
Assistant Professor |
| Affiliation |
Nitte Institute of Physiotherapy |
| Address |
Nitte Institute of Physiotherapy,
NITTE (DU), P.O 12. Deralkatte, Mangalore - 575018
Karnataka, India
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
7760547669 |
| Fax |
|
| Email |
nityalkumar2020@nitte.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Mr Nityal Kumar |
| Designation |
Assistant Professor |
| Affiliation |
Nitte Institute of Physiotherapy |
| Address |
Nitte Institute of Physiotherapy,
NITTE (DU), P.O 12. Deralkatte, Mangalore - 575018
Karnataka, India
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
7760547669 |
| Fax |
|
| Email |
nityalkumar2020@nitte.edu.in |
|
|
Source of Monetary or Material Support
|
| Department of Physiotherapy, Room number 20, second base division, NITTE Institute of Physiotherapy, NITTE (Deemed to be University), Deralakatte, Mangaluru, Karnataka 575018, India |
|
|
Primary Sponsor
|
| Name |
Nitte Deemed to be University |
| Address |
Nitte Institute of Physiotherapy, NITTE (DU), PO 12. Deralkatte, Mangalore - 575018 Karnataka, India |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Bhoomika Bhat |
Justice K.S Hegde Charitable Hospital |
Nitte Institute of Physiotherapy,
NITTE (DU), P.O 12. Deralkatte, Mangalore - 575018
Karnataka, India
Nitte Institute of Physiotherapy,
NITTE (DU), P.O 12. Deralkatte, Mangalore - 575018
Karnataka, India
Dakshina Kannada
KARNATAKA |
07975609616
bhoomikabhat77@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics committee of Nitte Institute of Physiotherapy |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M953||Acquired deformity of neck, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Multimodal Physiotherapy |
Participants in this group will receive a combination of physiotherapy treatments with the following components
Soft Tissue Therapy (10 minutes per session):
Manual techniques applied to the neck, shoulder blade, and upper arm areas to reduce muscle tension and improve blood circulation.
Neck-Specific Exercises (15 minutes per session)
Exercises include chin tuck movements, eye coordination activities, and isometric exercises to strengthen and stabilize the neck.
Electrotherapy (TENS- 20 minutes per session)
Transcutaneous Electrical Nerve Stimulation applied over the neck at 100 Hz frequency and 250 microseconds pulse width, adjusted to provide a strong but comfortable sensation.
General Self-Care Exercises (20 minutes per session):
Active range of motion exercises for the neck and shoulder joints to maintain movement and reduce stiffness.
Patient Education:
Advice and guidance on posture correction, ergonomic practices, pain management strategies, and daily activity modifications.
Session Frequency and Duration:
Each session will last approximately 60 minutes, delivered 3 to 5 times per week for 4 weeks.
|
| Comparator Agent |
Traditional Physiotherapy |
Participants in this group will receive standard physiotherapy care including
Electrotherapy using Transcutaneous Electrical Nerve Stimulation for twenty minutes:
Electrical stimulation at one hundred Hertz frequency and two hundred fifty microsecond pulse duration, intensity adjusted according to participant comfort.
General Self-Care Exercises for twenty minutes
Active range of motion exercises targeting the neck and shoulder joints.
Session Duration and Frequency
Each session will last approximately forty minutes and will be conducted three to five times per week for four weeks. |
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Adults aged from nineteen years to sixty-five years.
Individuals who have been clinically diagnosed with neck pain.
Participants who report a pain intensity greater than thirty millimeters on the Visual Analogue Scale at the start of the study.
Participants who demonstrate a joint position error of five degrees or more during the baseline assessment of neck proprioception. |
|
| ExclusionCriteria |
| Details |
Exclusion criteria
History of trauma or injury to the cervical spine.
Individuals with diagnosed vestibular disorders or severe impairments in Visual-Vestibular Interaction.
Individuals with diagnosed vestibular disorders
Presence of severe psychiatric disorders affecting compliance.
Involvement in other therapeutic interventions for neck pain during the study period.
Any contraindications to exercise or electrotherapy.
No previous neck surgery or invasive interventions within the last 6 months.
No neurological deficits or severe comorbidities affecting participation
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Visual Analogue Scale (VAS) |
Baseline (Pre-intervention)
After 4 weeks (Post-intervention) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Joint Position Sense Error Test
Gait Analysis |
Baseline (Pre-intervention)
After 4 weeks (Post-intervention) |
|
|
Target Sample Size
|
Total Sample Size="32"
Sample Size from India="32"
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
|
Phase 1 |
|
Date of First Enrollment (India)
|
15/07/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| 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
|
The primary purpose of this randomized controlled trial is to evaluate the effectiveness of multimodal physiotherapy compared to traditional physiotherapy in patients with neck pain. The study aims to assess and compare improvements in pain intensity, joint position sense, and gait parameters between the two groups. It is hypothesized that multimodal physiotherapy will be more effective in reducing pain, improving cervical proprioception, and enhancing gait than traditional physiotherapy alone. |