| CTRI Number |
CTRI/2024/04/065342 [Registered on: 08/04/2024] Trial Registered Prospectively |
| Last Modified On: |
02/06/2025 |
| 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
|
Addition of Mulligan SNAGs over proprioceptive exercises on Proprioception and Kinesiophobia in Neck Pain |
|
Scientific Title of Study
|
Effect of addition of Mulligan SNAGs over Proprioceptive Training on Joint Position Sense and Kinesiophobia in Mechanical Neck Pain: A Randomized Clinical Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Khadeeja Ansari |
| Designation |
Post graduate student |
| Affiliation |
Smt Kashibai Navale College of Physiotherapy |
| Address |
Electrotherapy and Electrodiagnosis Department, Second floor, Smt Kashibai Navale College of Physiotherapy,Off westerly bypass road Narhe Pune
Pune
MAHARASHTRA
411041
India |
| Phone |
07588712924 |
| Fax |
|
| Email |
khadeejaansari8490@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Richa Bisen |
| Designation |
Assistant Professor |
| Affiliation |
Smt Kashibai Navale College of Physiotherapy |
| Address |
Electrotherapy and Electrodiagnosis Department, second floor Smt Kashibai Navale College of Physiotherapy, Off westerly bypass road Narhe Pune
Pune
MAHARASHTRA
Richa Bisen
India |
| Phone |
09923827415 |
| Fax |
|
| Email |
reechu28@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Khadeeja Ansari |
| Designation |
Post graduate student |
| Affiliation |
Smt Kashibai Navale College of Physiotherapy |
| Address |
Electrotherapy and Electrodiagnosis Department Second Floor, Smt Kashibai Navale College of Physiotherapy,Off westerly bypass road Narhe Pune
Pune
MAHARASHTRA
411041
India |
| Phone |
07588712924 |
| Fax |
|
| Email |
khadeejaansari8490@gmail.com |
|
|
Source of Monetary or Material Support
|
| Smt Kashibai Navale College of Physiotherapy, Sr.No 48/55/1, 48/56/1, Off westerly bypass Narhe Pune Maharashtra |
|
|
Primary Sponsor
|
| Name |
Smt Kashibai Navale College of Physiotherapy |
| Address |
Department of Electrotherapy and Electrodiagnosis, Off westerly bypass Narhe Pune |
| 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 Richa Bisen |
Smt Kashibai Navale Medical College and General Hospital |
Physiotherapy OPD, Ground floor OPD No 10, off westerly bypass Narhe Pune
Pune
MAHARASHTRA |
9923827415
reechu28@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Smt. Kashibai Navale College of Physiotherapy |
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 |
Mulligan SNAGs along with proprioceptive training |
Mulligan SNAGs will be applied for neck pain, 6-8 repetitions, 3 sets, 3 times/week for 2 weeks.
Proprioceptive training improves the joint position sense and consist of head relocation, gaze stability, eye follow and eye-head coordination exercises. 3 sets of 5 repetitions, 3 session/week for 4 weeks, treatment duration: 30 minutes. After 2 weeks, proprioceptive training will be continued at home as home program. |
| Comparator Agent |
Sham Mulligan SNAGs along with Proprioceptive training |
In Sham Mulligan SNAGs, hand position will be similar to that of Mulligan SNAG applied on patient for the same duration but without application of any forces. Proprioceptive training consist of head relocation, gaze stability, eye follow and eye-head coordination exercises. 3 sets of 5 repetitions, 3 session/week for 4 weeks, tratment duration: 30 minutes. After 2 weeks, proprioceptive training will be continued at home as home program.
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Mechanical neck pain of more than 3 months
Joint position error of more than 7.1cm
pain intensity more than 3 out of 10 |
|
| ExclusionCriteria |
| Details |
History of cervical spine surgery or trauma
Cervical pain with specific diagnosis like cervical spondylosis
Metabolic bone disease
Tumour or infection involving cervical spine
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Joint position error measured with joint position error test
Kinesiophobia measured with Tampa Scale 17
|
baseline, 2 weeks, 4 weeks
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Pain intensity measured by numerical pain rating scale |
baseline, 2 weeks, 4 weeks |
|
|
Target Sample Size
|
Total Sample Size="46"
Sample Size from India="46"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
30/04/2024 |
| Date of Study Completion (India) |
02/07/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="20" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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)
|
This parallel group design randomized clinical trial will evaluate the additional effect of mulligan SNAGs over proprioceptive training on joint position sense and kinesiophobia on patients with mechanical neck pain. Intervention will be delivered for 2 weeks and blinded assessment will be performed at baseline, after 2 weeks and after 4 weeks. |