| CTRI Number |
CTRI/2023/03/050578 [Registered on: 10/03/2023] Trial Registered Prospectively |
| Last Modified On: |
03/10/2024 |
| Post Graduate Thesis |
Yes |
| 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 scapular stabilization exercises on pain, function and quality of life in chronic neck pain. |
|
Scientific Title of Study
|
Effect of scapular stabilization exercises on pain, posure, disability,
and quality of life in chronic neck pain : An open-label randomized controlled trial. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Prachita Walankar |
| Designation |
Associate Professor |
| Affiliation |
MGM College of Physiotherapy, Navi Mumbai |
| Address |
Department of Musculoskeletal Physiotherapy, MGM College of Physiotherapy,Plot-46, Sector 30 A, Vashi, Navi Mumbai
Thane
MAHARASHTRA
400705
India |
| Phone |
|
| Fax |
|
| Email |
prachita30@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prachita Walankar |
| Designation |
Associate Professor |
| Affiliation |
MGM College of Physiotherapy, Navi Mumbai |
| Address |
Department of Musculoskeletal Physiotherapy, MGM College of Physiotherapy,Plot-46, Sector 30 A, Vashi, Navi Mumbai
Thane
MAHARASHTRA
400705
India |
| Phone |
|
| Fax |
|
| Email |
prachita30@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Monika Ambade |
| Designation |
MPT Scholar |
| Affiliation |
MGM College of Physiotherapy, Navi Mumbai |
| Address |
Department of Musculoskeletal Physiotherapy, MGM College of Physiotherapy,Plot-46, Sector 30 A, Vashi, Navi Mumbai
Thane
MAHARASHTRA
400705
India |
| Phone |
|
| Fax |
|
| Email |
monikaambade001@gmail.com |
|
|
Source of Monetary or Material Support
|
| MGM College of Physiotherapy, Plot no 46, Sector 30 A, Vashi-400705, Navi Mumbai |
|
|
Primary Sponsor
|
| Name |
Nil |
| Address |
Nil |
| Type of Sponsor |
Other [Nil] |
|
|
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 |
| Prachita Walankar |
MGM Hospital |
Plot No. 1 & 2, Sector-1, NH-4 Junction, Mumbai - Pune Hwy, Kamothe, Navi Mumbai, Maharashtra 410209
Raigarh
MAHARASHTRA |
9967102303
prachita30@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee MGM Dental College and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M542||Cervicalgia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional exercises |
exercises for mobility, flexibility,
strengthening and stabilization for cervical spine.
Total duration of intervention - 4 weeks
Three sessions per week |
| Intervention |
Scapular Stabilization exercises |
Scapular muscle strengthening exercises
Total duration of intervention - 4 weeks
Three sessions per week |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Individuals diagnosed with chronic neck pain which persisted for more than 3months.
Both males and females.
Subjects willing to participate in the study. |
|
| ExclusionCriteria |
| Details |
Individuals with history of spinal or upper extremity surgery.
Individuals with spinal fractures or significant history of trauma
Individuals with cervical radiculopathy, cervical stenosis,rheumatoid arthritis, inflammatory disease, ankylosing spondylitis, cervical myelopathy.
Individuals with thoracic outlet syndrome and whiplash injury
Individuals with history of malignancy, acute trauma and acute infection
Individuals with neurological ,cardiorespiratory or psychiatric involvement
Pregnant women
Subjects not willing to participate in the study. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Numerical pain rating scale
Posture analysis
Neck Disability Index
SF-36 |
Baseline and four weeks post intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
16/03/2023 |
| Date of Study Completion (India) |
12/06/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response (Others) - Data will be made available upon reasonable request by the principal investigator prachita30@gmail.com
- For how long will this data be available start date provided 19-04-2024 and end date provided 19-04-2027?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - Nil
|
|
Brief Summary
|
Chronic Neck pain is one of the most common musculoskeletal
disorder, where patient perceives pain and discomfort around the
neck region; eventually resulting in restricted neck movements. Chronic neck pain causes
limitations in activities of daily living, resulting in impaired quality
of life. In recent years, neck pain has become a
widespread chronic problem, and the problem cannot be completely
resolved; therefore, the relationship between the neck region and the
shoulder, back, and scapular regions has begun to be emphasized in
many studies. There is increasing interest in scapular stabilization for patients
with chronic neck pain because of the close relationship between the
neck and scapula. Despite more comprehensive
rehabilitation programs being conducted for the treatment of neck
pain, little is known about the potential benefits of scapular
stabilization exercise on neck pain. Studies investigating the role
of the scapula on neck pain mostly focus on the acute effects of
active or passive scapular correction neck pain. In the literature, it has been reported that scapular stabilization
exercises should be added to the treatment program, as they provide
mobility and functional gain in patients with neck pain. However, the potential effects of stabilization training remain
uncertain in patients with chronic neck pain. The aim of the study
was to investigate the effects of 4-week scapular stabilization
exercises along with conventional exercise on pain, posture,
disability and quality of life in patients with chronic neck pain |