| CTRI Number |
CTRI/2025/06/088877 [Registered on: 16/06/2025] Trial Registered Prospectively |
| Last Modified On: |
13/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To compare the effectiveness between McKenzie extension exercises and swiss ball exercises on pain and lumbar range of motion in participants with PIVD |
|
Scientific Title of Study
|
Comparison of the effectiveness of McKenzie extension exercises versus swiss ball exercises on pain, lumbar rom and functional disability among subjects with PIVD |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sai Vennela Mogili |
| Designation |
Master of physiotherapy - Neurology |
| Affiliation |
Sri Venkateswara institute of Medical sciences |
| Address |
Department of physiotherapy, college of physiotherapy SVIMS , Tirupati, Andhra Pradesh
Department of physiotherapy, college of physiotherapy SVIMS , Tirupati, Andhra Pradesh
Chittoor
ANDHRA PRADESH
517501
India |
| Phone |
7013994288 |
| Fax |
|
| Email |
saivennela2420@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. V .Sri Kumari |
| Designation |
Associate professor |
| Affiliation |
Sri Venkateswara institute of Medical sciences |
| Address |
Department of physiotherapy, college of physiotherpay,SVIMS , Tirupati, Andhra Pradesh
Chittoor
ANDHRA PRADESH
517501
India |
| Phone |
9490181120 |
| Fax |
|
| Email |
vadlamudi_jyo@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Sai Vennela Mogili |
| Designation |
Master of physiotherapy - Neurology |
| Affiliation |
Sri Venkateswara institute of Medical sciences |
| Address |
Department of physiotherapy,College of physiotherapy, SVIMS , Tirupati, Andhra Pradesh
Department of physiotherapy,College of physiotherapy, SVIMS , Tirupati, Andhra Pradesh
Chittoor
ANDHRA PRADESH
517501
India |
| Phone |
7013994288 |
| Fax |
|
| Email |
saivennela2420@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Venkateswara Institute of Medical Sciences
Tirupati
Andhra Pradesh
India - 517507 |
|
|
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 |
| Dr V Sri kumari |
Sri Venkateswara institute of Medical sciences |
Department of physiotherapy, college of physiotherapy, Tirupati, Andhra Pradesh
Chittoor
ANDHRA PRADESH |
7013994288
saivennela2420@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sri Venkateswara Institute of Medical sciences INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G55||Nerve root and plexus compressionsin diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
McKenzie extension exercises |
McKenzie extension exercises centralize pain , decrease functional disability and improve spinal mobility.
For 3 weeks |
| Comparator Agent |
N/A |
N/A |
| Comparator Agent |
Swiss ball exercises |
Swiss ball exercises are stabilization exercises that strengthen core muscles, decrease pain perception, increase trunk mobility, decrease functional disability and improve spinal mobility
For 3 weeks |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
1. PIVD grade 1 and grade 2
2. Prolapsed disc with radiating pain to one lower limb
3. Duration of low back pain is from 1 to 3 months
4. Subjects of Oswestry disability score-15 to 34
5. Had not received prior exercises particularly specific abdominal and spinal stabilization,
and manipulation. |
|
| ExclusionCriteria |
| Details |
1. Any recent spinal surgery or advised for surgery
2. Subjects with L.B.P of duration less than one month and more than 3 months
3. Subjects with any renal diseases
4. Subjects with spinal conditions like tumors, spondylolisthesis, infection and spinal
fracture , spinal tuberculosis.
5. Inflammatory joint disease
6. Pregnancy
7. General health problems which prevent from participating in an exercise program |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Numerical pain rating scale |
3 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Modified Schobers Index |
3 weeks |
| Oswestry Disability Index |
3 weeks |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
25/06/2025 |
| 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="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
|
The purpose of the study will be to compare the effectiveness of McKenzie extension exercises and Swiss ball exercises in reducing pain, improving lumbar range of motion (ROM), and decreasing functional disability among subjects diagnosed with prolapsed intervertebral disc (PIVD). |