| CTRI Number |
CTRI/2025/07/090213 [Registered on: 04/07/2025] Trial Registered Prospectively |
| Last Modified On: |
03/07/2025 |
| 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
|
To Compare the Effectiveness of McKenzie Approach Versus Positional Release Technique Along With Segmental Spinal Stabilization in Patients With Non-Specific Neck Pain |
|
Scientific Title of Study
|
To Compare the Effectiveness of McKenzie Approach Versus Positional Release Technique along with Segmental Spinal Stabilization on 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 |
Srishti Sharma |
| Designation |
Post Graduate Student |
| Affiliation |
Shri Guru Ram Rai University School of Paramedical and Allied Health Sciences |
| Address |
Department of Physiotherapy,Shri Mahant Indiresh Hospital
Dehradun
UTTARANCHAL
248001
India |
| Phone |
6396958113 |
| Fax |
|
| Email |
drsrishtisharma772@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sharda Sharma |
| Designation |
Associate Professor |
| Affiliation |
Shri Guru Ram Rai University School of Paramedical and Allied Health Sciences |
| Address |
Department of Physiotherapy,Shri Mahant Indiresh Hospital
Dehradun
UTTARANCHAL
248001
India |
| Phone |
8630382470 |
| Fax |
|
| Email |
shardasharma.physio@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Srishti Sharma |
| Designation |
Post Graduate Student |
| Affiliation |
Shri Guru Ram Rai University School of Paramedical and Allied Health Sciences |
| Address |
Department of Physiotherapy,Shri Mahant Indiresh Hospital
Dehradun
UTTARANCHAL
248001
India |
| Phone |
6396958113 |
| Fax |
|
| Email |
drsrishtisharma772@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shri Guru Ram Rai University, School of Paramedical and Allied Health Sciences, Pathribag, Dehradun, Uttarakhand, 248001 |
|
|
Primary Sponsor
|
| Name |
Srishti Sharma |
| Address |
Shri Guru Ram Rai University, School of Paramedical and Allied Health Sciences, Pathribag, Dehradun, Uttarakhand, 248001 |
| Type of Sponsor |
Other [Self] |
|
|
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 Srishti Sharma PT |
Shri Mahant Indiresh Hospital |
Shri Mahant Indiresh Hospital Department of Physiotherapy North Block Basement, Dehradun,248001
Dehradun
UTTARANCHAL |
6396958113
drsrishtisharma772@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committe(IEC)Shri Guru Ram Rai Institute of Medical and Health Sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M959||Acquired deformity of musculoskeletal system, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Mckenzie Approach with Segmental Spinal Stabilization |
Participants in this group will receive Mckenzie Approach applied in supine lying and sitting positions by a trained physiotherapist.After mckenzie technique,segmental spinal stabilization is provided.3 sessions per week for 6 weeks(18 sessions in total) |
| Comparator Agent |
Positional Release Technique with Segmental Spinal Stabilization |
Participants in this group will receive Positional Release Technique applied in supine lying and sitting positions by a trained physiotherapist.After positional release technique,segmental spinal stabilization is provided.3 sessions per week for 6 weeks(18 sessions in total) |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
Both males and females
Patients with non-specific neck pain
Restricted cervical range of motion |
|
| ExclusionCriteria |
| Details |
1.Fracture
2.Tumors
3.Infection
4.Inflammatory diseases
5.Neurological deficits
6.Chronic pathological pain
7.Conditions that could affect their ability to participate in the exercises |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
NPRS-Numeric Pain Rating Scale
NDI-Neck Disability Index
Goniometer |
Baseline
Mid-intervention(3rd week)
Post-intervention(6th week) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
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="0"
Months="6"
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
|
This randomized comparative experimental study aims to evaluate and compare the effectiveness of Mckenzie approach and Positional release technique along with Segmental spinal stabilization in the treatment of non-specific neck pain. A total of 50 participants aged 18 to 45 years will be randomly assigned into two equal groups. Group A will receive Mckenzie approach with Segmental spinal stabilization and Group B will receive Positional release technique with Segmental spinal stabilization. Both groups will undergo treatment three times per week for six weeks. Outcome measures including pain measured by Numeric pain rating scale (NPRS) , functional disability assessed by Neck disability index (NDI) and cervical range of motion measured by Goniometry and will be assessed at baseline, mid-intervention(3rd week) and post-intervention(6th week).The study seeks to determine which advance therapy provides superior clinical outcomes in pain relief mobility and functional improvement in patients with non-specific neck pain. |