| CTRI Number |
CTRI/2025/07/090689 [Registered on: 10/07/2025] Trial Registered Prospectively |
| Last Modified On: |
09/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Foam Rolling the Upper Back to Reduce Neck Pain.
|
|
Scientific Title of Study
|
Effect of 2 weeks Thoracic mobility training with Foam roller in patients with mechanical neck pain- An experimental study.
|
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Khadela Shruti Pravinbhai |
| Designation |
PG Scholar |
| Affiliation |
KPGU |
| Address |
Musculoskeletal and sports Department, Krishna School of Physiotherapy and Rehabilitation, Drs. Kiran & Pallavi Global University (KPGU), Vadodara-Mumbai NH8, Varnama, Vadodara, Gujarat 391243, India
Vadodara
GUJARAT
391243
India |
| Phone |
6355121314 |
| Fax |
|
| Email |
shrutikhadela2@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Camy Bhura PT |
| Designation |
Associate Professor |
| Affiliation |
KPGU |
| Address |
Musculoskeletal and sports Department, Krishna School of Physiotherapy and Rehabilitation, Drs. Kiran & Pallavi Global University (KPGU), Vadodara-Mumbai NH8, Varnama, Vadodara, Gujarat 391243, India
Vadodara
GUJARAT
391243
India |
| Phone |
7600058350 |
| Fax |
|
| Email |
camybhura.kspr@kpgu.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Khadela Shruti Pravinbhai |
| Designation |
PG Scholar |
| Affiliation |
KPGU |
| Address |
274, Rachna society Kapodra varachha road, Surat-395006
274, Rachna society Kapodra varachha road, Surat-395006
Surat
GUJARAT
395006
India |
| Phone |
6355121314 |
| Fax |
|
| Email |
shrutikhadela2@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Shruti Khadela |
| Address |
Musculoskeletal and sports Department, Krishna School of Physiotherapy and Rehabilitation, Drs. Kiran & Pallavi Global University (KPGU), Vadodara-Mumbai NH8, Varnama, Vadodara, Gujarat 391243, India |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| Khadela Shruti Pravinbhai |
Physiotherapy OPD, Matrushri Davalba Hospital. |
Matushree Davalba Hospital, Physiotherapy department, Vadodara- Mumbai, National Highway 8, Varnama, Vadodara-391243, Gujarat.
Vadodara
GUJARAT |
6355121314
shrutikhadela2@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee for Biomedical and Health Research, KPGU. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M953||Acquired deformity of neck, (2) ICD-10 Condition: M190||Primary osteoarthritis of other joints, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional Therapy |
Neck Isometric Exercise, Stretching of pectoralis and levator muscles with TENS for 10 minutes. |
| Intervention |
Thoracic Mobility Exercise |
•Reaching overhead (30 sec hold 3 times)
•Opposite arm stretch (5 sec hold 10 times)
•Thoracic spine and pectoralis stretch (30 sec hold 3 times)
•Thoracic spine and thoracic ROM (30 sec hold 3 times)
•Trapezoid stretch (10 times each side)
•Thoracic spine rotation (10 times each side)
•Extension (10 sec hold 10 times) |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
44.00 Year(s) |
| Gender |
Both |
| Details |
Age group 18-44 years.
Mechanical neck pain patients.
Having pain more than 6 month.
Spasm present over trapezius.
Both male and female.
|
|
| ExclusionCriteria |
| Details |
Systemic diseases.
Radiating symptoms.
Acute onset.
Any history of fracture or dislocation.
Any history of spine surgeries.
Any congenital diseases
History of trauma.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Pain
Functional ability
Thoracic Range of motion
Quality of life
|
2 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="42"
Sample Size from India="42"
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)
|
21/07/2025 |
| 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="5"
Days="0" |
|
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
|
The primary purpose of this protocol is to evaluate the effectiveness of a 2-week thoracic mobility training program using a foam roller in reducing pain and improving function in patients with mechanical neck pain. The study aims to address the underexplored role of thoracic spine mobility in cervical spine rehabilitation. Hypothesis:
It is hypothesized that thoracic mobility training with a foam roller will significantly reduce cervical pain and improve neck function in individuals with mechanical neck pain. |