| CTRI Number |
CTRI/2025/02/081048 [Registered on: 21/02/2025] Trial Registered Prospectively |
| Last Modified On: |
19/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
To evaluate the Efficacy of Manual Therapy in Patients with Neck Muscle Tightness. |
|
Scientific Title of Study
|
Effect of Instrument-Assisted Soft Tissue Mobilization and Shiatsu on Cervicogenic Headache. |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ashita |
| Designation |
Student |
| Affiliation |
Guru Jambheshwar University of Science and Technology |
| Address |
Department of Physiotherapy Guru Jambheshwar University of
Science and Technology Hisar
Hisar
HARYANA
125001
India |
| Phone |
9306472277 |
| Fax |
|
| Email |
ashitabhatia92@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Varun Singh |
| Designation |
Assistant Professor |
| Affiliation |
Guru Jambheshwar University of Science and Technology |
| Address |
Department of Physiotherapy Guru Jambheshwar University of
Science and Technology Hisar
Hisar
HARYANA
125001
India |
| Phone |
9802991664 |
| Fax |
|
| Email |
varunpoonia@gjust.org |
|
Details of Contact Person
Public Query
|
| Name |
Varun Singh |
| Designation |
Assistant Professor |
| Affiliation |
Guru Jambheshwar University of Science and Technology |
| Address |
Department of Physiotherapy Guru Jambheshwar University of
Science and Technology Hisar
Hisar
HARYANA
125001
India |
| Phone |
9802991664 |
| Fax |
|
| Email |
varunpoonia@gjust.org |
|
|
Source of Monetary or Material Support
|
| Department of Physiotherapy Guru Jambheshwar University of Science
and Technology Hisar Haryana India 125001 |
|
|
Primary Sponsor
|
| Name |
Ashita |
| Address |
Department of physiotherapy Guru Jambheshwar University of Science and Technology Hisar Haryana India 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 Varun Singh |
Department of Physiotherapy Guru Jambheshwar University of Science and Technology |
Room No 05 Department of Physiotherapy OPD Guru Jambheshwar University of Science and Technology Hisar Haryana India 125001
Hisar
HARYANA |
09802991664
varunpoonia@gjust.org |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee of GJUST |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G448||Other specified headache syndromes, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Instrument Assisted Soft Tissue Mobilization |
Patient in this group will receive Instrument Assisted Soft Tissue Mobilization 3 sessions per week for 4 weeks |
| Comparator Agent |
Shiatsu |
Patient in this group will receive Shiatsu 3 sessions per week for 4 weeks |
| Intervention |
Shiatsu with Instrument Assisted Soft Tissue Mobilization |
Patient in this group will receive Shiatsu and Instrument Assisted Soft Tissue Mobilization 3 sessions per week for 4 weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
Subjects with the age group between 18-30 years old.
Both gender.
The participants who are eligible for the criteria of cervicogenic headache (according to The International Headache Society). |
|
| ExclusionCriteria |
| Details |
Orthopaedic problems like fractures, acute neck injury, cervical surgery
Already had participated in a regular exercise program for the previous three months and received some medical treatment.
Uncooperative subject |
|
|
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 |
Pain will be assessed using the visual analogue scale (VAS).
Functional status will be assessed using validated neck disability index (NDI).
Headache status will be assessed by “headache quality of life” questionnaire |
The Outcomes will be assessed two times which is at baseline and after the four weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
The range of motion will be measured using a goniometer.
Strength of flexor & extensor muscles will be observed by MMT.
Cervical flexion rotation test will be conducted. |
The outcomes will be assessed for two times which is at the baseline & after the 4 weeks |
|
|
Target Sample Size
|
Total Sample Size="132"
Sample Size from India="132"
Final Enrollment numbers achieved (Total)= "132"
Final Enrollment numbers achieved (India)="132" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
16/03/2025 |
| Date of Study Completion (India) |
21/07/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="0"
Days="28" |
|
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
|
It is a randomized control trial with a duration of 4 weeks and involving 132 patients that will be divided into 3 groups based on the lottery method. It’s intervention involves Instrument Assisted Soft Tissue Mobilization and Shiatsu in one group and Shiatsu in second group and Instrument Assisted Soft Tissue Mobilization in third group. The patients will be informed about the study and written informed consent will be taken. First, each patient demographic information including age, height, weight will be gathered as a baseline data. Pre-intervention measurement of outcome variables including VAS, NDI, "headache quality of life" questionnaire, ROM, strength, CFRT will be taken. Intervention will be given for 4 weeks and then post-intervention data of all the outcome variables will be taken. |