| CTRI Number |
CTRI/2020/11/028915 [Registered on: 05/11/2020] Trial Registered Prospectively |
| Last Modified On: |
03/11/2020 |
| 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
|
Effect of Active Vs Passive Exercise in Knee Pain. |
|
Scientific Title of Study
|
Effect of Active Vs Passive Movement with Mobilization on Pain & Range of motion in Patients with Chronic Osteoarthritis Knee. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Saniya Palkar |
| Designation |
Post Graduate Student |
| Affiliation |
Dr.D.Y.Patil College of Physiotherapy. |
| Address |
PG-2 Classroom,3rd Floor,Dr.D.Y.Patil College of Physiotherapy,Sant Tukaram Nagar,Pimpri,Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
8888720000 |
| Fax |
|
| Email |
saniyap112@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Seema Saini |
| Designation |
Professor |
| Affiliation |
Dr.D.Y.Patil College of Physiotherapy. |
| Address |
Dr.D.Y.Patil Physiotherapy OPD,Ground floor,
Cabin no -1,Dr.D.Y.Patil College of Physiotherapy,Sant Tukaram Nagar,Pimpri,Pune.
Pune
MAHARASHTRA
411018
India |
| Phone |
8087564345 |
| Fax |
|
| Email |
seema.saini@dpu.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Saniya Palkar |
| Designation |
Post Graduate Student |
| Affiliation |
Dr.D.Y.Patil College of Physiotherapy. |
| Address |
PG-2 Classroom,3rd Floor,Dr.D.Y.Patil College of Physiotherapy,Sant Tukaram Nagar,Pimpri,Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
8888720000 |
| Fax |
|
| Email |
saniyap112@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr.D.Y.Patil College of Physiotherapy,Pune. |
|
|
Primary Sponsor
|
| Name |
Saniya Palkar |
| Address |
Flat no-102,Siddhashila Abha bld,Vidhate Path,Aundh,Pune. |
| 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 |
| Saniya Palkar |
Dr.D.Y.Patil College of Physiotherapy,Pune. |
Physiotherapy OPD,1st Cabin,Ground floor,Sant Tukaram Nagar,Plot No-BGP/190,Pimpri,Pune.
Pune
MAHARASHTRA |
8888720000
saniyap112@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Dr. D.Y.Patil Vidyapeeth |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M171||Unilateral primary osteoarthritisof knee, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Mulligan Mobilization with Active Movement at knee along with conventional physiotherapy treatment. |
Active movement with mobilization at knee will recieve 10 reps,3 sets for 8 days 2 weeks.Treatment time will be around 35-45 mins along with conventional therapy for both the groups. |
| Comparator Agent |
Mulligan Mobilization with Passive Movement at knee with conventional physiotherapy treatment |
Passive movement with mobilization at knee will receive 10 reps,3 sets for 8 days 2 weeks. Treatment time will be around 35-45 mins along with conventional therapy for both the groups. |
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1.Unilateral Osteoarthritis, participants who met the American College of Rheumatology (ACR) criteria for diagnosing knee OA by using history and physical examination, which contains presence of pain in knee joint plus any 3 of 6 factors.
-Bony enlargement,bony tenderness
-Bi-compartmental(tibio-femoral) knee joint osteoarthritis.
-Average knee pain 5 cm on visual analogue scale.
-Crepitus on active joint motion .
-Morning stiffness less than 30 min duration .
-No palpable warmth .
|
|
| ExclusionCriteria |
| Details |
1.Acute exacerbation in or around knee joint.
2.Traumatic injury to the knee joint within 6 months of study.
3.Any recent surgical intervention or intra-articular steroid injection to the knee joint within three months.
4.Peripheral vascular diseases.
5.Rheumatoid arthritis ,severe cardiopulmonary disease,uncontrolled HTN ,known neurological and psychological impairment.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Visual analog scale(VAS)
Knee range of motion
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
|
Visual analog scale(VAS)
Knee range of motion
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
8 sessions, 2 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Timed up and go
Q angle. |
8 sessions,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)
|
13/11/2020 |
| 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="6"
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
|
This study is experimental ,interventional trial to compare effectiveness of active and passive movement with mobilization for 2 weeks-8 sessions in a period of 6 months in patients with chronic osteoarthritis knee which will be conducted in Dr. D. Y .Patil College of Physiotherapy ,Pune. Primary outcome measures will be pain and range of motion at knee. The participants will be divided into 2 groups one with Active movement and other with passive movement on basis of simple random sampling by chit method ,the participants will be assessed for Pain by using Visual analog scale ,ROM by use of goniometer, physical functional assessment by use of WOMAC INDEX .For both the groups introduction will be given, intervention will be for 2 weeks 8 sessions along with conventional physiotherapy. Assessment will be taken on 1st day before commencement of intervention and on the last day that is on 8th day post intervention. |