| CTRI Number |
CTRI/2024/05/067039 [Registered on: 08/05/2024] Trial Registered Prospectively |
| Last Modified On: |
23/04/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of Mobilization and Soft Tissue Manipulation in Neck Pain |
|
Scientific Title of Study
|
Effect of Mobilization and Soft Tissue Manipulation in Patients with Mechanical Neck Pain: A Randomized Controlled 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 |
Sakshi Singh |
| Designation |
Student |
| Affiliation |
Guru Jambheshwar University of Science and Technology |
| Address |
Department of Physiotherapy Guru Jambheshwar University of Science and Technology
Hisar
HARYANA
125001
India |
| Phone |
9306743540 |
| Fax |
|
| Email |
ss.sakshisingh11@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Meenakshi Bagri |
| Designation |
Assistant Professor |
| Affiliation |
Guru Jambheshwar University of Science and Technology |
| Address |
Department of Physiotherapy Guru Jambheshwar University of Science and Technology
Hisar
HARYANA
125001
India |
| Phone |
9253266586 |
| Fax |
|
| Email |
meenakshi.physio7@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Meenakshi Bagri |
| Designation |
Assistant Professor |
| Affiliation |
Guru Jambheshwar University of Science and Technology |
| Address |
Department of Physiotherapy Guru Jambheshwar University of Science and Technology
Hisar
HARYANA
125001
India |
| Phone |
9253266586 |
| Fax |
|
| Email |
meenakshi.physio7@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Physiotherapy Guru Jambheshwar University of Science and Technology Hisar- 125001, Haryana, India |
|
|
Primary Sponsor
|
| Name |
Department of Physiotherapy |
| Address |
Guru Jambheshwar University of Science and Technology Hisar- 125001, Haryana |
| Type of Sponsor |
Other [University] |
|
|
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 Meenakshi Bagri |
Guru Jambheshwar University of Science and Technology Physiotherapy |
Room No. 5, Department of Physiotherapy
Hisar
HARYANA |
9253266586
meenakshi.physio7@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Commitee of GJUS&T |
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 |
| Comparator Agent |
Hot Pack |
Subjects of this group will
receive intervention with hot
pack on neck for twenty minutes and effect are immediately measured after the treatment.
|
| Intervention |
Mobilization |
Subjects of this group will
receive treatment with hot pack plus cervical mobilization for twenty minutes and effect are immediately measured after the treatment. |
| Intervention |
Soft Tissue Manipulation(STM) |
Subjects of this group will receive treatment with hot pack plus soft tissue manipulation for twenty minutes and effect are immediately measured after the treatment. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
A history of chronic neck pain .i.e pain from past 3 months
Mechanical neck pain without radiculopathy, spondylosis and disc prolapsed.
|
|
| ExclusionCriteria |
| Details |
Patients on medication for neck pain
Radiating pain in hand
Any cardiovascular problem
Any respiratory related problem
Any psychological problem
Metabolic problem
Other orthopedic condition other than neck pain
Meningitis
Any other health related problems
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Visual Analogue Scale [VAS]
Neck Disability Index [NDI]
|
The outcome will be assessed for two times which is at baseline and immediately after the treatment.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Cervical Range of Motion(ROM) |
The outcome will be assessed for two times which is at baseline and immediately after the treatment.
|
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
15/05/2024 |
| 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="0"
Days="28" |
|
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
|
It is randomized controlled trial with immediate effects and involving sixty patients that will be divided into three groups based on the random method. It’s intervention involves mobilization in one group, soft tissue manipulation in second group and hot pack in control group. The patient will be informed about the study and written consent will be taken. Firstly each patient’s demographic information including age, height and weight will be gathered as a baseline data. Pre intervention measurements of outcome measures including VAS, NDI and ROM on mechanical neck pain will be taken . Intervention will be given for twenty minutes and then post interventions data of all outcome measures will taken. |