| CTRI Number |
CTRI/2025/02/080501 [Registered on: 13/02/2025] Trial Registered Prospectively |
| Last Modified On: |
12/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
DNS Technique and its effect on Quality of Life and Pain in Mechanical Neck Pain Patients |
|
Scientific Title of Study
|
Effect of Dynamic Neuromuscular Stabilization exercises on Pain, Disability, Range of motion and Quality of Life among patients with Chronic Mechanical Neck Pain: A Quasi Experimental Study |
| Trial Acronym |
CMNP, DNS, NPRS, NDI, ROM, QOL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Astha Shakyawar |
| Designation |
Post Graduate Student (MPT) |
| Affiliation |
Chhatrapati Shahu ji Maharaj University, Kanpur |
| Address |
Department of Physiotherapy, School of Health Sciences, Chhatrapati Shahu ji Maharaj University, Kanpur
Department of Physiotherapy, School of Health Sciences, Chhatrapati Shahu ji Maharaj University, Kanpur
Kanpur Nagar
UTTAR PRADESH
208024
India |
| Phone |
7007926147 |
| Fax |
|
| Email |
asthashakyawar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Apoorva Srivastava |
| Designation |
PHD scholar |
| Affiliation |
Chhatrapati Shahu ji Maharaj University, Kanpur |
| Address |
Room No.129, Department of Physiotherapy, School of Health Sciences, Chhatrapati Shahu ji Maharaj University, Kanpur
Room No.129, Department of Physiotherapy, School of Health Sciences, Chhatrapati Shahu ji Maharaj University, Kanpur
Kanpur Nagar
UTTAR PRADESH
208024
India |
| Phone |
8953634686 |
| Fax |
|
| Email |
apoorva.pt12@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Digvijay Sharma |
| Designation |
Director, Associate Professor |
| Affiliation |
Chhatrapati Shahu ji Maharaj University, Kanpur |
| Address |
Department of Physiotherapy, School of Health Sciences, Chhatrapati Shahu ji Maharaj University, Kanpur
Department of Physiotherapy, School of Health Sciences, Chhatrapati Shahu ji Maharaj University, Kanpur
Kanpur Nagar
UTTAR PRADESH
208024
India |
| Phone |
9839217108 |
| Fax |
|
| Email |
digvijaysharma@csjmu.ac.in |
|
|
Source of Monetary or Material Support
|
| Department of Physiotherapy, School Of Health Sciences, Chhatrapati Shahu Ji Maharaj
University, Kanpur, Uttar Pradesh, India Pin code- 208024 |
|
|
Primary Sponsor
|
| Name |
Astha Shakyawar |
| Address |
Department of Physiotherapy, School of Health Sciences,
Chhatrapati Shahu Ji Maharaj University, Kanpur, Uttar Pradesh,
India Pin Code- 208024 |
| Type of Sponsor |
Other [Self Finance] |
|
|
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 |
| Apoorva Srivastava |
Chhatrapati Shahu Ji Maharaj University Kanpur |
Department of Physiotherapy, School of Health Sciences, Chhatrapati Shahu ji Maharaj University, Kanpur
Department of Physiotherapy, School of Health Sciences, Chhatrapati Shahu ji Maharaj University, Kanpur
Kanpur Nagar
UTTAR PRADESH |
8953634686
apoorva.pt12@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Chhatrapati Shahu Ji Maharaj University, Kanpur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M95-M95||Other disorders of the musculoskeletal system and connective tissue, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Dynamic Neuromuscular Stabilization Exercises |
Neuromuscular Stabilization Exercises will we rendered to all the included samples after signing of the consent |
| Comparator Agent |
Not Applicable |
Not Applicable |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
Age between 20 to 40 years both male and female
Non-specific neck pain for at least 3 months
NPRS score greater than two
NDI score greater than four
|
|
| ExclusionCriteria |
| Details |
Previous cervical spine injury, surgery
Whiplash Fibromyalgia
Pregnancy Degenerative diseases
Severe trauma
Neurological diseases eg cervical radiculopathy, myelopathy
Chronic inflammatory disorders
Primary neoplasm, metastasis
Cauda equina syndrome
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Numeric pain rating scale (NPRS)
Neck disability Index (NDI)
|
2 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Goniometry
Quality of life (QOL) |
2 |
|
|
Target Sample Size
|
Total Sample Size="41"
Sample Size from India="41"
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)
|
25/02/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
25/02/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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 purpose of the study is to evaluate that how Dynamic Neuromuscular stabilization(DNS) exercises influence the pain levels, disability, range of motion and overall quality of life among patients with Chronic Mechanical Neck pain(CMNP). The objective of the study is to reduce pain, prevent or reduce disability, improve the range of motion and quality of life among patients with chronic mechanical neck .
The methodology of the study reveals that the study is a Quasi-experimental study and will be conducted in the Physiotherapy OPD of School of Health Sciences, Chhatrapati Shahu Ji Maharaj University, Kanpur. The samples will be collected by purposive sampling method. Age between 20 to 40 years who have non-specific neck pain for at least three months with Numeric pain rating score greater that 2, Neck disability index score greater than four have been chosen and a sample size of 41 has been selected. Outcome measures like Numeric Pain Rating Scale(NPRS), Neck Disability Index(NDI), Goniometry, and Quality of Life (QOL) will be used to assess the pre and post test results.
|