| CTRI Number |
CTRI/2024/05/067156 [Registered on: 10/05/2024] Trial Registered Prospectively |
| Last Modified On: |
09/05/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Role of Combined effect of Static Stretching and Ischemic Release on Neck Pain |
|
Scientific Title of Study
|
Effect of Combination of Static Stretching And Ischemic Release On 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 |
Mamta |
| Designation |
Student |
| Affiliation |
Guru Jambheshwar University of Science and technology, Hisar |
| Address |
Department of Physiotherapy, Guru Jambheshwar University of Science and technology, HISAR
Hisar
HARYANA
125001
India |
| Phone |
9306161199 |
| Fax |
|
| Email |
vermamamta282002@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sujata Sharma |
| Designation |
Assistant Professor |
| Affiliation |
Guru Jambheshwar University of Science and technology Hisar |
| Address |
Department of Physiotherapy, Guru Jambheshwar University of Science and technology, HISAR
Hisar
HARYANA
125001
India |
| Phone |
9416918688 |
| Fax |
|
| Email |
sujatasharmaphysio@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sujata Sharma |
| Designation |
Assistant Professor |
| Affiliation |
Guru Jambheshwar University of Science and technology Hisar |
| Address |
Department of Physiotherapy, Guru Jambheshwar University of Science and technology, HISAR
Hisar
HARYANA
125001
India |
| Phone |
9416918688 |
| Fax |
|
| Email |
sujatasharmaphysio@gmail.com |
|
|
Source of Monetary or Material Support
|
| university of science and technology Hisar Haryana 125001 |
|
|
Primary Sponsor
|
| Name |
Health center Department of Physiotherapy |
| Address |
Department of Physiotherapy, Guru Jambheshwar University of Science and Technology ,Hisar ,Haryana 125001 |
| Type of Sponsor |
Research institution |
|
|
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 Mamta |
Guru jambeshwar university of science and technology |
Department Of Physiotherapy Room no 05 OPD (outpatient Department)
Hisar
HARYANA |
9306161199
vermamamta282002@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Commitee Department of Physiotherapy Guru Jambheshwar university of science and technology y |
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, (2) ICD-10 Condition: M708||Other soft tissue disorders related to use, overuse and pressure, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Static Stretching and ischemic release on non specific neck pain |
Patient will perform static exercises and ischemic release for two weeks . |
| Intervention |
Static stretching and ischemic release on non specific neck pain |
Patient will perform stretching exercises and ischemic release for two weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
Non specific neck pain for more than 3 months. |
|
| ExclusionCriteria |
| Details |
1. Recent fracture of cervical spine.
2. History of inflammatory joint disorders infectious,metabolic and malignant diseases .
3.Any previous cervical spine surgery.
4.Diagnosis of epilepsy.
5.Presence of open wound on cervical region.
6.History of neck pain due to any specific spinal pathological cause.
7.Uncoperative patient and patient not willing to participate in the study.
8.Presence of any condition or any other reason due to which patient is unable to participate in the study. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Neck Disability Index(NDI)
Visual Analog Scale(VAS) |
At the baseline
After 2 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Goniometer |
At the baseline
After two weeks |
|
|
Target Sample Size
|
Total Sample Size="35"
Sample Size from India="35"
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
21/05/2024 |
| 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="2"
Days="5" |
|
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
|
Various studies have been done to examine the effect of static stretching and ischemic release individually but no study has explored the effect of static stretching and ischemic release on patients with non specific neck pain specially on parameters VAS, NDI, Goniometer therefore the present study aims to evaluate the effect of static stretching and ischemic release on range of motion , pain disability in management of non specific neck pain. |