| CTRI Number |
CTRI/2023/12/060897 [Registered on: 28/12/2023] Trial Registered Prospectively |
| Last Modified On: |
23/12/2023 |
| 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
|
Effects of vibration on muscle activity, pain, disability and performance in low back pain patients: A study |
|
Scientific Title of Study
|
Effect of Whole-body Vibration on Muscle Activation, Pain, Disability and Functional Performance in Chronic Low Back Pain Patients: 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 |
Dr Saurabh Sharma |
| Designation |
Associate Professor |
| Affiliation |
Jamia Millia Islamia |
| Address |
Room no-104, First floor, Centre for Physiotherapy and Rehabilitation Sciences, Jamia Millia Islamia, Maulana Mohammad Ali Jauhar Marg, Jamia Nagar, Okhla, New Delhi-110025
South
DELHI
110025
India |
| Phone |
9899214134 |
| Fax |
|
| Email |
ssharma@jmi.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Saurabh Sharma |
| Designation |
Associate Professor |
| Affiliation |
Jamia Millia Islamia |
| Address |
Room no-104, First floor, Centre for Physiotherapy and Rehabilitation Sciences, Jamia Millia Islamia, Maulana Mohammad Ali Jauhar Marg, Jamia Nagar, Okhla, New Delhi-110025
DELHI
110025
India |
| Phone |
9899214134 |
| Fax |
|
| Email |
ssharma@jmi.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Tasneem Zafar |
| Designation |
Post graduate student |
| Affiliation |
Jamia Millia Islamia |
| Address |
Room no-104, First floor, Centre for Physiotherapy and Rehabilitation Sciences, Jamia Millia Islamia, Maulana Mohammad Ali Jauhar Marg, Jamia Nagar, Okhla, New Delhi-110025
South
DELHI
110025
India |
| Phone |
7289954670 |
| Fax |
|
| Email |
tasneem.zafar1999@gmail.com |
|
|
Source of Monetary or Material Support
|
| Jamia Millia Islamia, Maulana Mohammad Ali Jauhar Marg, Jamia Nagar, Okhla, New Delhi,
110025 |
|
|
Primary Sponsor
|
| Name |
Jamia Millia Islamia |
| Address |
Centre for Physiotherapy and Rehabilitation Sciences, Jamia Millia Islamia, Maulana Mohammad Ali Jauhar Marg, Jamia Nagar, Okhla, New Delhi,
110025 |
| Type of Sponsor |
Other [Central 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 Saurabh Sharma |
Physiotherapy clinic, Centre of Physiotherapy and Rehabilitation Sciences, Jamia Millia Islamia |
Physiotherapy clinic,
Ground floor, Centre for Physiotherapy and Rehabilitation Sciences, Jamia Millia Islamia, Maulana Mohammad Ali Jauhar Marg, Jamia Nagar, Okhla, New Delhi-110025
South
DELHI |
9899214134
ssharma@jmi.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Jamia Millia Islamia |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G892||Chronic pain, not elsewhere classified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Whole body vibration |
Whole body vibration at constant frequency is given in 6 positions for 8 weeks, 3days/week, 25 minutes/session |
| Comparator Agent |
Whole body vibration |
Whole body vibration at progressive frequency is given in 6 positions for 8 weeks, 3days/week, |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Ages from 35- 60 years old.
CLBP from at least 12 weeks underneath 12th rib and above the gluteal fold without any specific causes.
No sign and symptom of neurological deficit.
Patient should not have musculoskeletal complaint apart from LBP.
Numerical pain scale between 2 to 7.
Body mass index <24.5 |
|
| ExclusionCriteria |
| Details |
Undergone previous surgery, dislocation, fracture, rheumatoid arthritis, ankylosing spondylitis and disc pathology
Organic disease, cardiovascular disease, progressive neuromuscular deficit, or severe osteoporosis
Pregnant or lactating,
Numerical Pain Scale <2 and ≤8
Attended WBV exercise in last 3 months |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Electromyographic (EMG) readings of Multifidus, Erector spinae, Rectus Abdominis, and Abdominal external obliques |
Electromyographic (EMG) reading will be assessed at baseline and at 8th week after completion of the intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Visual Analog score to measure pain intensity |
outcomes will be assessed at baseline and after the end of intervention at 8th week. |
| Roland Morris Disability Questionnaires to measure functional disability |
outcomes will be assessed at baseline and after the end of intervention at 8th week. |
| Progressive isoinertial lifting evaluation test to measure functional performance by lifting specific amounts of weight. |
outcomes will be assessed at baseline and after the end of intervention at 8th week. |
|
|
Target Sample Size
|
Total Sample Size="34"
Sample Size from India="34"
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)
|
01/01/2024 |
| 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="6"
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
|
Background And Need of Research: Non-specific Chronic low back pain(NSCLBP) is a prevalent issue in developed societies and a significant cause of disability. Whole-body vibration exercise has emerged as a new treatment method, but additional research is necessary to determine the optimal parameters of WBVE that would be beneficial for patients experiencing chronic musculoskeletal pain Objective: To investigate the Effects of Whole-body Vibration on muscle activation, pain, disability and functional performance in patients with Non-Specific Chronic low back pain patients. Methods: A single-blinded randomized controlled trial including 34 eligible patients will be conducted after their random allocation to either group A or group B receiving 25 min of Whole-body Vibration Exercise at constant and progressive frequencies respectively for 3 days per week for total of 8 weeks. Outcome measures will include muscle activity, pain, disability and muscle performance at baseline and after the 8th week. Conclusion: Findings will provide evidence of the effectiveness of the Whole-body vibration exercise in NSCLBP . Further, it will add knowledge for evidence-based practice and health promotion to physiotherapists in treating chronic low back pain. |