| CTRI Number |
CTRI/2024/01/061348 [Registered on: 10/01/2024] Trial Registered Prospectively |
| Last Modified On: |
03/01/2024 |
| 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
|
Physiotherapeutic intervention in patients having both pronated feet and low back pain. The purpose of this study- Exercises will be given to the low back pain patients having low arch foot. Exercises will be focused on both the lower limb and lower back. |
|
Scientific Title of Study
|
STUDIES ON UNDERSTANDING THE ROLE OF PHYSIOTHERAPEUTIC INTERVENTIONS IN PRONATED FEET SUBJECTS HAVING CHRONIC LOW BACK PAIN |
| Trial Acronym |
NILL |
|
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 (A Central University) |
| Address |
Centre for Physiotherapy and Rehabilitation Sciences, Jamia Nagar
New Delhi, Pin- 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 (A Central University) |
| Address |
Centre for Physiotherapy and Rehabilitation Sciences, Jamia Nagar
New Delhi, Pin- 110025
South
DELHI
110025
India |
| Phone |
9899214134 |
| Fax |
|
| Email |
ssharma@jmi.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Md Farhan Alam |
| Designation |
Research Scholar |
| Affiliation |
Jamia Millia Islamia (A Central University) |
| Address |
Centre for Physiotherapy and Rehabilitation Sciences, Jamia Nagar
New Delhi, Pin- 110025
Centre for Physiotherapy and Rehabilitation Sciences, Jamia Nagar
New Delhi, Pin- 110025
South
DELHI
110025
India |
| Phone |
09069679200 |
| Fax |
|
| Email |
farhanphysio@gmail.com |
|
|
Source of Monetary or Material Support
|
| Jamia Millia Islamia, Jamia Nagar, New Delhi 110025 |
|
|
Primary Sponsor
|
| Name |
Centre for Physiotherapy and Rehabilitation Sciences |
| Address |
Jamia Millia Islamia, Jamia Nagar, 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 |
Jamia Millia Islamia |
Room no 2, PhD Laboratory, Ground floor, Centre for Physiotherapy and Rehabilitation Sciences, 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: M539||Dorsopathy, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
conventional physiotherapy of trunk for 6 weeks. |
trunk exercises only, which include strength and flexibility exercises.
duration- 6 weeks |
| Intervention |
Physiotherapy interventions (lower limb & trunk) for 6 weeks |
lower limb exercises include pronated feet and kinetic chain correction
trunk exercises include strength and flexibility exercises.
Duration- 6 weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Bilateral pronated feet based on ND more than 10mm
Foot Posture Index more than or equal to 6
History of back pain - more than 3 months
Pain on NPRS more than 2
Disability index more than 10 on RMDQ
Normal BMI
Anterior pelvic tilt- more than 8 degree
No orthosis use |
|
| ExclusionCriteria |
| Details |
Arthritis of lower extremities.
Foot, ankle or lumbar spinal surgeries
Diabetes.
Other foot abnormalities or deformities.
Pathological symptoms of lower limb for last 6 months.
Disc prolapsed or radiating pain
Neurological diseases or vestibular dysfunction
Biomechanical abnormalities which may alter gait pattern.
Any acute injury of lower limb
Limb length discrepancies of more than 5mm
Psychological disorders |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| gait, muscle function and postural stability |
pre and post intervention
baseline and at the 6 week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| pain, disability, quality of life, flexibility and foot posture |
pre and post intervention
baseline and at the 6 week |
|
|
Target Sample Size
|
Total Sample Size="64"
Sample Size from India="64"
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)
|
15/01/2024 |
| 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="8"
Days="10" |
|
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
|
Low back pain (LBP) is a prevalent orthopedic ailment that afflicts up to 80% of the population at some point in their lifetime. Among the various biomechanical foot disorders, foot pronation is a major factor affecting the incidence of mechanical LBP. Previously, only limited studies have been conducted to treat patients with both pronated feet and low back pain. However, no study has compared the treatment of lower limb exercises to back exercises. This study aims to determine if adding lower limb exercises (targeting pronated feet and kinetic chain correction) to trunk exercises (focusing on flexibility and strength) would result in better outcomes in terms of foot posture, muscle functions, walking patterns, and flexibility compared to trunk exercises alone in subjects with pronated feet experiencing chronic low back pain (CLBP). A total of 64 subjects will be randomly assigned to Group A (n=32) and Group B (n=32), with most exercises being administered three days per week for a duration of 6 weeks. All outcomes will be assessed at baseline and post-intervention. This trial will be conducted at Jamia Millia Islamia (A Central University), New Delhi, India. |