| CTRI Number |
CTRI/2021/01/030333 [Registered on: 08/01/2021] Trial Registered Prospectively |
| Last Modified On: |
08/01/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA)
Behavioral |
| Study Design |
Other |
|
Public Title of Study
|
An eKnee School for patients suffering from knee osteoarthritis |
|
Scientific Title of Study
|
Establishing eknee School for knee osteoarthritis patients during COVID19- A quasi experimental study
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Prof MS Dhillon |
| Designation |
Professor |
| Affiliation |
PGIMER |
| Address |
Department of Orthopaedics,PGIMER,Chandigarh
Sector12
Chandigarh
CHANDIGARH
160012
India |
| Phone |
|
| Fax |
|
| Email |
drdhillon@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof MS Dhillon |
| Designation |
Professor |
| Affiliation |
PGIMER |
| Address |
Department of Orthopaedics,PGIMER,Chandigarh
Sector12
Chandigarh
CHANDIGARH
160012
India |
| Phone |
|
| Fax |
|
| Email |
drdhillon@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof Amarjeet Singh |
| Designation |
Professor |
| Affiliation |
PGIMER |
| Address |
Head of the Department
Department of Community Medicine and SPH
PGIMER
Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9814472226 |
| Fax |
|
| Email |
dramarjeet56@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
PGIMER |
| Address |
sector 12
Chandigarh |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Prof MS Dhillon |
PGIMER |
Room no 1005
PGIMER
Chandigarh
CHANDIGARH |
01722756743
drdhillon@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M179||Osteoarthritis of knee, unspecified, (2) ICD-10 Condition: M179||Osteoarthritis of knee, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Routine OPD care |
Routine OPD care |
| Intervention |
set of exercises, Dos & Don’t, Yoga, meditation, dietary management & lifestyle modifications |
Links of the sessions will be provided to the patients (set of exercises, Dos & Don’t, Yoga, meditation, dietary management & lifestyle modifications) after the recruitment. All the enrolled patients will be provided with e-link of patient education booklets containing the details of various components e.g., descriptions and pictures of the set of exercises. Customization of the exercises in consultation with orthopaedic surgeon, a physiotherapist, and patients/caregivers will be done. Online supervised group sessions will be held by physiotherapists, Orthopaedists, and other experts for six months. |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Agree to alter their lifestyle and willing to follow up.
Are aged 40 - 65 years of either gender.
Kellgren/Lawrence [K/L] (grade ≥1).
Patients having knee pain, the presence of osteophytes in the patellofemoral joint on 30° flexion lateral radiographs.
IT savvy - patient or caregiver
|
|
| ExclusionCriteria |
| Details |
The study will exclude patients awaiting surgery, those with deformity or intra-articular pathology, and those who have undergone hip or unilateral knee replacement, significant cardiac co-morbidity, body mass index [BMI] >40 or any comorbidity not allowing proper exercise protocol. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
EQ5DL
WOMAC
VAS
ICER |
Baseline and Endline(6 months)
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Performance-based tests |
Baseline and Endline(6 months) |
|
|
Target Sample Size
|
Total Sample Size="126"
Sample Size from India="126"
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)
|
10/01/2021 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Osteoarthritis (OA) is a
leading cause of chronic disability after the age of 40 years. Weight-bearing joints, especially
knee joint, is most affected leading to knee osteoarthritis (KOA). Intractable pain is the most common symptom
reported by KOA patients. The current study is proposed with an
objective to ascertain the impact of online
supervised non- pharmacological sessions among mild and moderate KOA patients
in comparison to routine care; additional objective was assessment of cost-effectiveness
of eKS against the routine care for KOA patients. |