| CTRI Number |
CTRI/2024/04/066230 [Registered on: 24/04/2024] Trial Registered Prospectively |
| Last Modified On: |
12/04/2024 |
| 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
|
Effects of footwear modification on patients with osteoarthritis of knee |
|
Scientific Title of Study
|
Effects of lateral wedge insole versus lateral wedge with medial arch support insole on pain, functional activities and joint space reduction in tibiofemoral osteoarthritis of knee |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Arpitha D |
| Designation |
Post Graduate student |
| Affiliation |
Shri Dharmasthala Manjunatheshwara College of Physiotherapy |
| Address |
OPD number 5,orthopedic physiotherapy department, SDM college of medical sciences and hospital, sattur
Dharwad
KARNATAKA
580009
India |
| Phone |
8073010031 |
| Fax |
|
| Email |
arpithad7676@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Arpitha D |
| Designation |
Post Graduate student |
| Affiliation |
Shri Dharmasthala Manjunatheshwara College of Physiotherapy |
| Address |
OPD number 5,orthopedic physiotherapy department, SDM college of medical sciences and hospital, sattur
Dharwad
KARNATAKA
580009
India |
| Phone |
8073010031 |
| Fax |
|
| Email |
arpithad7676@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sunil K M |
| Designation |
Professor and PG Guide |
| Affiliation |
Shri Dharmasthala Manjunatheshwar College of Physiotherapy |
| Address |
OPD number 5,orthopedic physiotherapy department, SDM college of medical sciences and hospital, sattur
Dharwad
KARNATAKA
580009
India |
| Phone |
9880260626 |
| Fax |
|
| Email |
sunilkm789@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shri Dharmasthala Manjunatheshwara College of Physiotheraphy Manjushree Nagar,Sattur,Dharwad,Karnataka,India.580009 |
|
|
Primary Sponsor
|
| Name |
Arpitha D |
| Address |
OPD number 5 orthopedic physiotherapy department ,Shri Dharmasthala Manjunatheshwara College of Medical Sciences and hospital,Sattur |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| Arpitha D |
SDM university, Dharwad |
OPD number 5, Orthopedic physiotherapy departmet, SDM college of medical sciences and hospital, Manjushree Nagar Sattur, Dharwad
Dharwad
KARNATAKA |
8073010031
arpithad7676@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M170||Bilateral primary osteoarthritis of knee, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
lateral heel rise |
increasing heel rise on the lateral side for 8 weeks |
| Intervention |
lateral heel rise with medial arch support |
increasing heel rise on the lateral side along with medial arch support using insole for 8 weeks |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Age group 40 -80
1. Early to midstage (KL grade 2-3) OA of the medial compartment of the
knee based on recent X-RAY
2.Subjects able to walk independently
3.Average knee pain of at least 3 out of 10(using VAS)
ï‚· Either of the gender
ï‚· Bilateral osteoarthritis of knee
ï‚· Subjects with varus deformity of knee |
|
| ExclusionCriteria |
| Details |
knee surgery or intra articular injections for pain
1.History of knee joint replacement or tibial osteotomy
2. Foot or ankle problems that contraindicated the use of footwear load
modifying interventions
3.Relevant ligamentous instability
4.Relevant OA of lateral compartment of knee based on X-ray
5. History of fracture in the of area knee joint which is under the study
6. Any major lower limb surgery in the past
7.Locomotion with assistive device
8.Neurological disorders such as stroke
9.Grade 4 of KL classification
10.Cardiac and respiratory conditions |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
WOMAC
VAS
joint space measurement
Range of motion |
baseline and after 8weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Range of motion
muscle strength
hamstring tightness
|
baseline and after 8weeks |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
05/05/2024 |
| 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="1"
Months="0"
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
|
osteoarthritis is a chronic degenerative condition characterized by bone remodeling and articular cartilage loss patients with osteoarthritis mainly complains of pain joint stiffness ,functional impairments intensity of symptoms vary from patients to patients .one of the initial steps in the diagnosis of osteoarthritis is joint space narrowing less space restricts joints range of motion .resulting in stiffness and increases stress on joint recent research confirms the link between knee and foot problems in people with knee osteoarthritis ,on examination it is showed that 25% people reported pain in the foot and during dynamic walking the effect of genu varum is causing subtalar joint pronation during loading and propulsive phase of gait numerous research have hypothesized that changing ones footwear can reduce pressure on the medial knee joint which in turn reduce pain and enhance functional status .but there is lack of evidence on comparison of effects of lateral wedges with medial arch support and lateral heel rise therefore the need of this study to compare to different footwear modification along with physiotherapy treatment in osteoarthritis patients here in my study we are including 60 patients from 40 - 80 years both male and female with grade 2 and grade 3 osteoarthritis based on x-ray and patients with genu varum and allocating them into two different groups group A and group B and assessing pain ,joint space, range of motion, muscle strength, functional ability on WOMAC on day one and after 8 weeks group A will receive lateral wedge with medial arch support and group B will receive lateral heel rise only and data will be analyzed using statistical t test comparing baseline and post intervention
|