| CTRI Number |
CTRI/2024/03/063510 [Registered on: 04/03/2024] Trial Registered Prospectively |
| Last Modified On: |
01/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Effectiveness of manual therapy in low back pain with mulligans mobilization technique and specific exercise |
|
Scientific Title of Study
|
Effectiveness of mulligans spinal mobilization with leg movement (SMWLM) and specific exercise conditioning on the clinical outcome in individuals with lumbar radiculopathy |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Prathap rr |
| Designation |
Mpt orthopaedics student |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research |
| Address |
Faculty of Physiotherapy
No.1 Ramachandra Nagar
Porur, Chennai - 600 116
Chennai
TAMIL NADU
600116
India |
| Phone |
9092456178 |
| Fax |
|
| Email |
prathapravichandran100@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
subbiah k |
| Designation |
Associate professor |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research |
| Address |
Faculty of Physiotherapy
No.1 Ramachandra Nagar
Porur, Chennai-600116
Chennai
TAMIL NADU
600116
India |
| Phone |
9443033118 |
| Fax |
|
| Email |
subbiah@sriramachandra.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Prathap rr |
| Designation |
Mpt orthopaedics student |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research |
| Address |
Faculty of Physiotherapy
No.1 Ramachandra Nagar
Porur, Chennai-600116
Chennai
TAMIL NADU
600116
India |
| Phone |
9092456178 |
| Fax |
|
| Email |
prathapravichandran100@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri ramachandra institute of higher education and research
Faculty of Physiotherapy
No.1 Ramachandra Nagar
Porur, Chennai-600116 |
|
|
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 prathap rr |
Sri Ramachandra Institute of Higher Education and Research |
No.1 Ramachandra Nagar
Porur, Chennai - 600 116
Chennai
TAMIL NADU |
9092456178
prathapravichandran100@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ETHICS COMMITTEE FOR STUDENTS PROJECTS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M541||Radiculopathy, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
spinal mobilization with leg movement |
Spinal mobilization with leg
movement, neural mobilization,
lumbar spine ROM exercises and
electrotherapy
duration-2 weeks |
| Comparator Agent |
Spinal mobilization with leg movement and rotational exercise |
Spinal mobilization with leg
movement, neural mobilization,
lumbar rotation exercise and
electrotherapy
duration-2 weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients with unilateral lumbar radiculopathy, Age from 18 to 60 years, Both male and female |
|
| ExclusionCriteria |
| Details |
Contraindications for manual therapy, Age more than 60 years, Bladder and bowel dysfunction, Physiotherapy/surgery for leg pain within 6 months, Lower extremity vascular disease
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Visual analog scale – Leg pain intensity, Numerical pain rating scale, Oswestry disability index, Abdominal core muscle strength |
2 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Lumbar range of motion, Global rating of change, Passive straight leg raise |
2 weeks |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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 1 |
|
Date of First Enrollment (India)
|
14/03/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
14/03/2024 |
| 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 Yet Recruiting |
| 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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Informed Consent Form
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- 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) - Verbal
- For how long will this data be available start date provided 06-10-2023 and end date provided 30-03-2024?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - nil
|
|
Brief Summary
|
a randomized controlled trial will be conducted on individuals with lumbar radiculopathy and the patients will be put into 3 groups. group 1 will receive neural mobilization, lumbar spine range of motion exercises and electrotherapy for pain modulation. group 2 will receive spinal mobilization with leg movement, neural mobilization, lumbar spine range of motion exercises and electrotherapy for pain modulation. group 3 will receive spinal mobilization with leg movement, neural mobilization, lumbar spine range of motion exercises, lumbar rotation exercise and electrotherapy for pain modulation |