| CTRI Number |
CTRI/2024/12/077648 [Registered on: 04/12/2024] Trial Registered Prospectively |
| Last Modified On: |
25/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
Development and testing of a standard sequential Physiotherapy Protocol for patients with Osteoarthritis
Knee.
|
|
Scientific Title of Study
|
Development and testing of an Evidence Based
Physiotherapy Protocol for Subjects with Osteoarthritis
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 |
Dr Tanvi Banker |
| Designation |
Assistant Professor |
| Affiliation |
SPB Physiotherapy college, Surat |
| Address |
Musculoskeletal Department,SPB Physiotherapy college, Ugat-Bhesan road, Surat-395005.
Surat
GUJARAT
395005
India |
| Phone |
08460835751 |
| Fax |
|
| Email |
tanvibanker@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vivek Ramanandi |
| Designation |
Associate Professor |
| Affiliation |
SPB Physiotherapy college, Surat |
| Address |
Neurological department,SPB Physiotherapy college, Ugat-Bhesan road, Surat-395005.
Surat
GUJARAT
395005
India |
| Phone |
08460835751 |
| Fax |
|
| Email |
vivekramanandi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Tanvi Banker |
| Designation |
Assistant Professor |
| Affiliation |
SPB Physiotherapy college, Surat |
| Address |
Musculoskeletal department,SPB Physiotherapy college, Ugat-Bhesan road, Surat-395005.
Surat
GUJARAT
395005
India |
| Phone |
08460835751 |
| Fax |
|
| Email |
tanvibanker@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Tanvi Banker |
| Address |
SPB Physiotherapy college, Ugat-Bhesan road, Surat-395005. |
| 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 |
| Dr Tanvi Banker |
SPB Physiotherapy OPD |
Musculoskeletal department of SPB Physiotherapy college.
Surat
GUJARAT |
08460835751
tanvibanker@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical committee(SPB PHYSIOTHERAPY COLLEGE) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M179||Osteoarthritis of knee, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional Physiotherapy Intervention Protocol for OA knee |
Conventional treatment (control group).Treatment will be given 5 days a week up to 4 weeks. Total treatment duration will be 40 minits/session. |
| Intervention |
Evidence based physiotherapy protocol for OA knee. |
Evidence based physiotherapy protocol for OA knee which is obtained from the consensus. Treatment will be given 5 days a week up to 4 weeks. Total treatment duration will be 40 minits/session. |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Patient with primary OA knee as per Kellgren –
Lawrence classification Grade 1,2,3
2. Body Mass Index less than 24.9 kg/m2
3. Age Between 40 years to 65 years
4. Both Male and Female
5. Both unilateral and bilateral OA knee
6. Patient with knee pain, crepitations, stiffness
of joint.
7. Average knee pain on walking more than 3 on an
11-point scale
8. Person who knows Gujarati and English.
|
|
| ExclusionCriteria |
| Details |
1.Any inflammatory arthritis
2.Participants who have taken intra-articular
corticosteroid or hyaluronic injections
within last 6 months
3.Participants who have undergone through any
surgery related to same sided knee
joint in last 6 months.
4.Patients who have any ligamentous or meniscal
injury
5.Medical condition that hampering safe
participation in an exercise program.
6.Unable to ambulate without assistive device.
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
➢ Kellgren Lawrance X-Ray score
➢ Step test for balance
15
➢ Proprioception for joint position sense
➢ NPRS for pain
➢ 30 seconds sit to stand test for functionality
➢ WOMAC scale for disability
➢ TAMPA scale for kinesiophobia
➢ SF12 for quality of life
➢ Pittsburgh quality index for sleep quality
➢ Pressure pain threshold for central sensitization
➢ Back saver sit and reach test for flexibility
➢ Gait determinant -Cadence |
Before intervention and at the end of the 4th week of intervention. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
➢ TAMPA scale for kinesiophobia
➢ SF12 for quality of life
➢ Pittsburgh quality index for sleep quality
➢ Pressure pain threshold for central sensitization
➢ Back saver sit and reach test for flexibility
➢ Gait determinant -Cadence |
Before intervention and at the end of the 4th week of intervention. |
|
|
Target Sample Size
|
Total Sample Size="130"
Sample Size from India="130"
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)
|
01/06/2025 |
| 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
|
Till date there is no standard protocol available which goes in sequential
manner and focusing over multiple domains (e.g. rate of Structural changes, Pain,
Central sensitization, Functionality, Proprioception, Flexibility, Disability, Sleep
quality, Dynamic balance, Gait, Quality of life) for patients with OA knee. The
traditional treatment plan which is being followed in clinics is not wholesome.
Usually, it includes one or other therapy as an adjustive therapy which focuses over
limited domains and patient never gets satisfied with traditional or traditional along
with adjustive therapy.
Being an academician, PG Guide and a physiotherapist- seeing OPD
Patients and their expectations I found a research gap regarding standard sequential
evidence-based protocol. So, need of the study is to establish a standard evidence based protocol which follows the particular chronological order according to
mechanism of action and which can cover almost every domains (e.g. rate of
structural changes, pain, central sensitization, functionality, proprioception,
flexibility, disability, functionality, Sleep quality, dynamic balance, gait, quality of
life) which gets affected in OA knee. |