| CTRI Number |
CTRI/2022/07/043671 [Registered on: 04/07/2022] Trial Registered Prospectively |
| Last Modified On: |
28/06/2022 |
| 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
|
Comparision of the effectiveness of Mckenzie Extension and Mulligan BLR techniques in Lumbar PIVD Condition |
|
Scientific Title of Study
|
Comparision of Mckenzie exercises and Mulligan bend leg raise techniques in lumbar PIVD conditions |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Varun Singh |
| Designation |
Assistant Professor |
| Affiliation |
Department of Physiotherapy |
| Address |
Room no. 109 Department of Physiotherapy Guru Jambheshwar university of science and technology,Hisar
Room no. 109 Department of Physiotherapy Guru Jambheshwar university of science and technology,Hisar
Hisar
HARYANA
125001
India |
| Phone |
9802991664 |
| Fax |
|
| Email |
dr.varunpoonia@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Varun Singh |
| Designation |
Assistant Professor |
| Affiliation |
Department of Physiotherapy |
| Address |
Room no. 109 Department of Physiotherapy Guru Jambheshwar university of science and technology,Hisar
Room no. 109 Department of Physiotherapy Guru Jambheshwar university of science and technology,Hisar
Hisar
HARYANA
125001
India |
| Phone |
9802991664 |
| Fax |
|
| Email |
dr.varunpoonia@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Ravina |
| Designation |
MPT Student |
| Affiliation |
Department of Physiotherapy |
| Address |
HOUSE NO-1024 SECTOR-3 ROHTAK
House no-1024,sector-3,Rohtak
Hisar
HARYANA
124001
India |
| Phone |
8571865679 |
| Fax |
|
| Email |
jangraravina881@gmail.com |
|
|
Source of Monetary or Material Support
|
| .Self(Ravina) MPT Student, Guru jambheshwar university of science and technology,Hisar |
|
|
Primary Sponsor
|
| Name |
Ravina |
| Address |
Department of Physiotherapy Guru Jambheshwar university of science and technology,Hisar |
| Type of Sponsor |
Other [Self funding] |
|
|
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 |
| Ravina |
Guru Jambheshwar university of science and technology,Hisar |
Department of Physiotherapy
Hisar
HARYANA |
8571865679
jangraravina881@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Department of Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M958||Other specified acquired deformities of musculoskeletal system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Mulligan Bend Leg Raises technique
|
Mulligan BLR technique for 6 days in a week for 4 week 3 repition in one session.
|
| Intervention |
Mckenzie Extension Exercises |
Mckenzie Extension Exercises for 6 days in a week for 4 week. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1.Age 20-50 years both male and female
2.Duration of low back pain more than 15 days,prolapsed disc with radiating and non radiating pain |
|
| ExclusionCriteria |
| Details |
1.Spinal surgery
2.Spondylolisthesis
3.Spinal Fractures
4.Spinal tuberculosis
5.Any renal diseases |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| reduce pain in Lumbar PIVD condition, reduce functional disability |
total 4 weeks study,6 session per week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| reduce back pain, imrove functional disability |
4 weeks study,6 session per week |
|
|
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)
|
05/07/2022 |
| 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="1"
Days="15" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Lumbar PIVD is a spinal condition that can cause lower back pain as well numbness, tightness of muscle ,pins and needles sensation and feeling of muscle weakness in the lower body.Mckenzie method is common intervention for patients with lumbar PIVD.The aim of this study is to evaluate the effect of Mckenzie Extension Exercises and Mulligan BLR technique IN lumbar PIVD condition.
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
PIVD condition leads to low back pain, tingling, numbness, tightness of muscles. The aim of the study was to compare the effect of Mckenzie extension exercises and Mulligan Bend Leg raise technique on pain for Low Back Pain of Lumbar prolapsed disc condition. |