| CTRI Number |
CTRI/2026/01/102645 [Registered on: 30/01/2026] Trial Registered Prospectively |
| Last Modified On: |
30/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Effect of Two Physiotherapy Treatments for Long Standing Neck Pain |
|
Scientific Title of Study
|
Effectiveness of Mobilization with Movement and Manual Diaphragm Release Technique on Pain and Range of Motion in Chronic Neck Pain RCT |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rutuja Udebhan Kailuke |
| Designation |
Master of Musculoskeletal Physiotherapy Student |
| Affiliation |
Maharashtra Institute of Physiotherapy Latur |
| Address |
Department of Musculoskeletal Physiotherapy OPD No 15 MIPT College MIMSR Campus Ambajogai Road Latur
Latur
MAHARASHTRA
413531
India |
| Phone |
7350736443 |
| Fax |
|
| Email |
rutujakailuke8156@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Subhash Khatri |
| Designation |
Principal and Professor at Maharashtra Institute of Physiotherapy |
| Affiliation |
Maharashtra Institute of Physiotherapy Latur |
| Address |
Department of Musculoskeletal Physiotherapy Maharashtra Institute of Physiotherapy OPD No 15 College MIMSR Campus Ambajogai Road Latur 413531
Latur
MAHARASHTRA
413531
India |
| Phone |
8830174477 |
| Fax |
02382-227246 |
| Email |
physiokhatri@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Subhash Khatri |
| Designation |
Principal and Professor at Maharashtra Institute of Physiotherapy |
| Affiliation |
Maharashtra Institute of Physiotherapy Latur |
| Address |
Department of Musculoskeletal Physiotherapy Maharashtra Institute of Physiotherapy OPD No 15 College MIMSR Campus Ambajogai Road Latur 413531
Latur
MAHARASHTRA
413531
India |
| Phone |
8830174477 |
| Fax |
02382-227246 |
| Email |
physiokhatri@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department Musculoskeletal Physiotherapy OPD No 15 Maharashtra Institute of Physiotherapy MIMSR Campus Ambajogai Road Latur 413531 Maharashtra India |
|
|
Primary Sponsor
|
| Name |
Maharashtra Institute of Physiotherapy Latur |
| Address |
Department of Musculoskeletal Physiotherapy OPD No 15 Maharashtra Institute of Physiotherapy MIMSR Campus Ambajogai Road Latur 413531 MS 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 Rutuja Udebhan Kailuke |
Maharashtra Institute of Physiotherapy Latur 413531 |
Department of Musculoskeletal Physiotherapy OPD No 15 Maharashtra Institute of Physiotherapy MIMSR Campus Ambajogai Road Latur 413531 Maharashtra India
Latur
MAHARASHTRA |
07350736443
rutujakailuke8156@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee (IEC) |
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 |
1)Manual Diaphragm Release Technique
2)Conventional Physiotherapy Protocol |
1)Manual Diaphragm Release Technique will be given to patient ,the therapist will make manual contact with the pisiform, hypothenar region and the last three fingers bilaterally to the underside of the seventh to tenth rib
costal cartilages In the inspiratory phase, the therapist will gently pull the points of contact with both hands in the direction of the head and slightly laterally, accompanying the elevation of the ribs. During exhalation, the therapist deepenes contact toward the inner
costal margin, maintaining resistance. In the subsequent respiratory cycles, the therapist progressively increased the depth of contact
inside the costal margin. The maneuver will be performed in two sets of 10 deep breaths, with a 1-minute interval between them . 6 Sessions over the period of 2 weeks
2) Conventional Physiotherapy Protocol - Moist hot Pack, TENS/IFT, Cervical ROM Exercise, Stretching Exercise, Isometric Neck Strengthening ,Postural Correction Exercise
|
| Intervention |
1)Mobilization With Moment (SNAG technique)
2)Conventional Physiotherapy Protocol |
1)Mobilization With Moment- Participants’s received SNAGs as described by Mulligan.5 repetitions will be performed then AROM will be reassess
3 repetitions in first session - 1 set Subsequent sessions - 10 repetitions - 5 sets. During the application of the glide, the participant
should stay symptom free and is instructed to stop moving if any pain is produced. This movement was repeated for 10 times. Duration is 8 sessions for 2 week
2)Conventional Physiotherapy Protocol -
Moist hot Pack, TENS/IFT, Cervical ROM Exercise, Stretching Exercise, Isometric Neck Strengthening ,Postural Correction Exercise
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1)Age 18-50 years
2)Current neck pain
3)Neck pain continued for at least the last 12 weeks 4)Both male and female |
|
| ExclusionCriteria |
| Details |
1)Neck pain associated with vertigo
2)Osteoporosis
3)Diagnosed psychological disorders
4)Vertebral fractures
5)Tumors
6)Diagnosed metabolic diseases
7)Previous neck surgery
8)Red flags (night pain, severe muscle spasm)
9)Physiotherapeutic treatment continued in the last 3 months |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1)Numerical pain
rating scale
(NPRS)
2)Range of motion by Goniometer
3)Functional Mobility by Neck Disability
Index (NDI) |
All the outcomes will be assessed at Baseline and the the end of 2 weeks post treatment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="96"
Sample Size from India="96"
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)
|
13/02/2026 |
| 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 Applicable |
| 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
|
This
randomized controlled trial aims to evaluate the effectiveness of manual
diaphragm release technique combined with movement with mobilization in
individuals with chronic neck pain. A total of 96 participants will be randomly
allocated into three groups and treated over a 2-week intervention period.
Outcomes including pain intensity (NPRS), cervical range of motion
(goniometry), and neck disability (NDI) will be assessed pre- and
post-intervention post 2 weeks . The study is conducted in a tertiary care
hospital setting using a simple random sampling method. Statistical analysis
will be performed using paired and unpaired t-tests and ANOVA, with
significance set at p < 0.05. The findings aim to provide evidence on the
role of diaphragm manual therapy as an adjunct to conventional cervical
mobilization in chronic neck pain management. |