| CTRI Number |
CTRI/2025/05/086589 [Registered on: 08/05/2025] Trial Registered Prospectively |
| Last Modified On: |
08/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Improving Range of Motion and Function in Non-Specific Neck Pain A Selective Treatment Approach |
|
Scientific Title of Study
|
Effect of selective treatment protocol on pain disability and ROM in patients with non-specific 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 |
Dnyaneshwari Vikhe |
| Designation |
MPT 1st Year |
| Affiliation |
Dr.Apj Abdul Kalam College Of Physiotherapy, Loni |
| Address |
Pravara institute of medical sciences India Loni Ahmednagar 413736 Room no 403
Pravara institute of medical sciences India Loni Ahmednagar 413736 Room no 403
Ahmadnagar
MAHARASHTRA
413736
India |
| Phone |
7083358857 |
| Fax |
|
| Email |
dnyaneshwarivikhe22@gmai.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Neeraj kumar |
| Designation |
Professor |
| Affiliation |
Dr.Apj Abdul Kalam College Of Physiotherapy, Loni |
| Address |
Pravara institute of medical sciences Dr APJ Abdul kalam college of physiotherapy Loni Ahmednagar 413736
Pravara institute of medical sciences Dr APJ Abdul kalam college of physiotherapy Loni Ahmednagar 413736
Ahmadnagar
MAHARASHTRA
413736
India |
| Phone |
09005411557 |
| Fax |
|
| Email |
drneerajpt@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Neeraj kumar |
| Designation |
PhD MPT Musculoskeletal |
| Affiliation |
Dr.Apj Abdul Kalam College Of Physiotherapy, Loni |
| Address |
Pravara institute of medical sciences loni ahmednagar 413736
room no 403
Pravara institute of medical sciences loni ahmednagar 413736
room no 403
Ahmadnagar
MAHARASHTRA
413736
India |
| Phone |
9005411557 |
| Fax |
|
| Email |
drneerajpt@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr APJ Abdul kalam college of Physiotherapy Pravara , institute of medical sciences India, 413736 |
| Musculoskeletal Physiotherapy department Dr APJ Abdul kalam college of Physiotherapy Pravara institute of medical sciences loni Ahmednagar 413736 |
|
|
Primary Sponsor
|
| Name |
Dr APJ Abdul kalam college of Physiotherapy Pravara instituteof medical sciences |
| Address |
Musculoskeletal Physiotherapy department Dr APJ Abdul kalam college of physiotherapy Pravara institute of medical sciences Loni Ahmednagar 413736 |
| Type of Sponsor |
Private medical college |
|
|
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 |
| DrDnyaneshwari vikhe |
Department of orthopaedic physiotherapy room no 403 |
Dr APJ Abdul kalam college of physiotherapy Pravara insitute of medical sciences loni ahliyanagar 413736 maharashtra , india room no 403
Ahmadnagar
MAHARASHTRA |
07083358857
dnyaneshwarivikhe22@gmai.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Insitutional ethical of dr. Apj abdul kalam COPT |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M628||Other specified disorders of muscle, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional |
Hot water fomentation 8-10 min
TENS 7 Min
Neck range of motion exercises 10 reps x 3 sets
Isometric Strengthening exercises 10 sec hold x 5 reps
4 weeks 6 days |
| Intervention |
Effect of selective Treatment protocol on pain disability and ROM in non-specific neck pain |
Week 1 and 2 Hot water fomentation TENS
Neck ROM exercises
Activation of cervical muscle
passive movement of cervical
spine with eye fixed
Scapular upward rotation
wall facing arm lift
Arm raise overhead in line with Lower trapezius muscle fibers Week 3 and 4 Hot water fomentation
TENS
Neck ROM exercises
Neck isometrics
Activation of cervical muscle
passive movement of cervical
spine with eye fixed
Head repositioning exercise
4 weeks 6 days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Aged between 18 to 50 years
Males and females
Nonspecific neck pain without any underlying pathologies
A minimum pain score 3 on a visual analog scale |
|
| ExclusionCriteria |
| Details |
Any recent surgical history around neck and Shoulder region
Any Autoimmune disease systemic illness rheumatic conditions
Any neurological condition. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Visual Analogue scale
Neck Disability Index
ROM Goniometer |
6 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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)
|
25/05/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
25/05/2025 |
| 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 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
|
NEED FOR THE STUDY:
Non-specific neck pain is a highly prevalent musculoskeletal condition that
significantly affects daily activities, productivity, and quality of life.
Neck-specific exercises and scapular stabilization exercises have individually
demonstrated positive effects on pain, functional disability, and range of motion .
Also there is paucity of literature on the combined use of these interventions within
a selective treatment protocol for non-specific neck pain.
Hence, we hypothesized that selective treatment protocol may have significant
implement in patients with non-specific neck pain may have improvement in
gaining the pain disability and ROM. AIM To find the effect of selective treatment protocol on pain, disability and ROM in patients
with non-specific neck pain OBJECTIVES:
• To find the effect of selective treatment protocol on Pain in patients with non
specific neck pain. To find the effect of selective treatment protocol on Neck disability in patients
with non-specific neck pain. To find the effect of selective treatment protocol on ROM in patients with
non- specific neck pain. |