| CTRI Number |
CTRI/2024/09/073841 [Registered on: 12/09/2024] Trial Registered Prospectively |
| Last Modified On: |
25/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Two physiotherapy techniques central PA Glide with Post Isometric Relaxation and Sustained Natural Apophyseal Glide and Passive Stretching given to measure the effectiveness in neck range of motion, pain, and disability in patient with Non-specific neck pain by a Randomized Controlled Trial study |
|
Scientific Title of Study
|
Comparison of Central Posterior-Anterior Glide and Post Isometric Relaxation versus Sustained Natural Apophyseal Glide and Passive Stretching in Non Specific Neck Pain a Randomized Controlled Trail. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Roshni sahu |
| Designation |
Post Graduate Student |
| Affiliation |
Sikkim Manipal College Of Physiotherapy |
| Address |
Sikkim Manipal College of Physiotherapy, Sikkim Manipal university, 5th mile Upper Tadong Gangtok, Sikkim Central Referral Hospital, Physiotherapy department OPD, Level 5. East SIKKIM 737102 India |
| Phone |
7002302491 |
| Fax |
|
| Email |
roshni_202304006@smims.smu.edu.in |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Pratik Chettri |
| Designation |
Associate Professor |
| Affiliation |
Sikkim Manipal College Of Physiotherapy |
| Address |
Sikkim Manipal College of Physiotherapy, Sikkim Manipal university, 5th mile, Upper Tadong. Central Referral Hospital, Physiotherapy department OPD, Level 5. East SIKKIM 737102 India |
| Phone |
9734941648 |
| Fax |
|
| Email |
pratik.c@smims.smu.edu.in |
|
Details of Contact Person Public Query
|
| Name |
Roshni sahu |
| Designation |
Post graduate student |
| Affiliation |
Sikkim Manipal College Of Physiotherapy |
| Address |
Sikkim Manipal College of Physiotherapy, Sikkim Manipal university, 5th mile Upper Tadong , Gangtok. Central Referral Hospital, Physiotherapy department OPD, Level 5. East SIKKIM 737102 India |
| Phone |
7002302491 |
| Fax |
|
| Email |
roshni_202304006@smims.smu.edu.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Central Referral Hospital |
| Address |
5th mile, Upper Tadong , Gangtok, East Sikkim, India -737102 |
| Type of Sponsor |
Private hospital/clinic |
|
|
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 Pratik chettri |
Sikkim Manipal Institute of Medical Sciences |
Level 5,Physiotherapy department, manipal,5th mile, Upper Tadong , Gangtok, Sikkim -737102
East SIKKIM |
9734941648
pratikchettri63@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMITTEE SIKKIM MANIPAL INSTITUTE OF MEDICAL SCIENCES |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M00-M99||Diseases of the musculoskeletal system and connective tissue, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Central PA glide and Post Isometric relaxation |
Central PA glide It is the
rhythmic and oscillatory
movement of the joint within the available range of motion. The total time for the PA mobilization intervention was approximately 10 minutes.(step 1)
Post isometric Relaxation requires moving a muscle as far as it can go without feeling any pain,
then maintain isometric contraction that position. The muscle contraction will be held for 7 seconds followed by relaxation for 3 seconds and then the muscle was gently stretched for 30
seconds. This procedure will be repeated for 3 times in both sides.(Step 2)
The Isometric exercise focus on the maintaining the strength of muscle of cervical muscle. (step 3)
|
| Intervention |
Mulligan Sustained Natural Apophyseal
Glides (SNAGs) and Passive Stretching
|
Mulligan SNAG- Mulligan
Sustained Natural Apophyseal
Glides (SNAGs) technique adds
a passive accessory glide,
parallel to the joint plane using a
vertebral spinous process or
transverse process, during
which the patient performs the
previously painful or restricted
active movement. The glides
were given for six repetitions for
three sets every session.
Sustained Natural Apophyseal Glide is a passive accessory glide will be administered and maintained until You complete a full
movement arc, which is restricted and painful. Throughout the process is without pain and
discomfort. (step1)
Passive Stretching is stretching technique for restricted flexibility In NSNP to elongate the
muscle fibers in a pain less manner. (Step 2)
The Isometric exercise focus on the maintaining the strength of muscle of cervical muscle. (step 3)
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
All genders with non specific neck pain.
• Age 18 – 60 years
• Visual Analogue Scale (VAS) more than
3.
• Negative spurling’s test |
|
| ExclusionCriteria |
| Details |
1. Red flags for irritability
2. Any recent history of fracture or injury at neck.
3.Any recent history of fracture or injury
in and around neck and shoulder, or
surgery
4. Unwilling to participate.
5. Patient with neurological condition like
nerve roots irritation due to herniated
disc, osteophyte or spinal stenosis.
6. Pregnancy. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. NDI (Neck Disability Index)
|
Measurements are taken on pre-intervention at
base line & after first week, second week (post intervention) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. VAS (Visual Analogue Scale)
2. BUBBLE INCLINOMETER |
Measurements are taken on pre-intervention at
base line & after first week, second week (post intervention) |
|
|
Target Sample Size
|
Total Sample Size="62" Sample Size from India="62"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="62" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
01/10/2024 |
| Date of Study Completion (India) |
01/05/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1" Months="0" Days="0" |
|
Recruitment Status of Trial (Global)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
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
Modification(s)
|
In this study we are recruiting patients of Non specific neck pain where we will recruit sixty two participants through randomization Group A will receive Central PA Glide with Post isometric relaxation and neck isometric exercise and Group B will receive SNAGs with Passive Stretching and neck Isometric exercise for five days per week for two weeks. Outcomes measured are Neck Disability Index for measuring disability, Visual Analogue Scale for pain intensity) , Bubble Inclinometer for measuring the range of motion , will be measured on pre intervention and post intervention after First week, and second week. Study will be done on Central Referral Hospital Physiotherapy Department, Upper Tadong, 5th Mile, Gangtok |