| CTRI Number |
CTRI/2024/10/075319 [Registered on: 15/10/2024] Trial Registered Prospectively |
| Last Modified On: |
09/10/2024 |
| 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
|
58 participants with osteoarthritis of knee are divided into 2 groups 1st group received conventional physiotherapy and 2nd group received conventional physiotherapy with tibial rotation. |
|
Scientific Title of Study
|
Effect of quadriceps strengthening exercise with tibial rotation and without tibial rotation on peak strength of quadriceps muscle improving pain and function in the patients with osteoarthritis of knee an experimental study |
| 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 Bansi Kundaliya |
| Designation |
PG Physiotherapy Student |
| Affiliation |
Government physiotherapy college, Jamnagar, Gujrat, India |
| Address |
Room number 33, exercise therapy department, government physiotherapy college, Jamnagar
Jamnagar
GUJARAT
361008
India |
| Phone |
9106941649 |
| Fax |
|
| Email |
bansikundaliya14@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Dinesh Sorani |
| Designation |
Principal of government physiotherapy college |
| Affiliation |
Government physiotherapy college, Jamnagar, Gujrat, India |
| Address |
Room number 1, Exercise therapy department, government physiotherapy college, jamnagar
Jamnagar
GUJARAT
361008
India |
| Phone |
7575042430 |
| Fax |
|
| Email |
bansikundaliya14@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Bansi Kundaliya |
| Designation |
PG Physiotherapy Student |
| Affiliation |
|
| Address |
Room number 33, OPD 1 exercise therapy department, government physiotherapy college, Jamnagar
Jamnagar
GUJARAT
361008
India |
| Phone |
9106941649 |
| Fax |
|
| Email |
bansikundaliya14@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Physiotherapy College,Jamnagar,India 361008 |
|
|
Primary Sponsor
|
| Name |
Government Physiotherapy College Jamnagar |
| Address |
Room number 33, OPD 1 exercise therapy department, government physiotherapy college, Jamnagar, Gujrat, India 361008 |
| Type of Sponsor |
Government medical college |
|
|
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 Bansi Kundaliya |
Government physiotherapy college jamnagar gujrat india |
Room number 33, OPD 1 exercise therapy department, government physiotherapy college, Jamnagar, Gujrat, India 361008
Jamnagar
GUJARAT |
9106941649
bansikundaliya14@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committee shree M.P. Shah Govt. Medical college and G. G. Govt. Hospital Jamnagar Gujrat India |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M00-M99||Diseases of the musculoskeletal system and connective tissue, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
conventional physical therapy |
Static quadriceps exercise,
strait leg raise in supine, prone and side lying
5 min static cycling,
hamstring curls,
quadriceps strengthening,
stretching of tight muscles for 5 sessions per week for four weeks |
| Comparator Agent |
conventional physical therapy with tibial rotation |
Static quadriceps exercise,
strait leg raise in supine, prone and side lying
5 min static cycling,
hamstring curls,
quadriceps strengthening with tibial rotation
stretching of tight muscles for 5 sessions per week for four weeks |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Subject willing to participate in study.
Patient fulfil the clinical criteria of American college of Rheumatology for osteoarthritis of knee.
Patients with radiological findings suggesting osteoarthritis of knee.
Medial joint space narrowing greater then lateral joint space narrowing shown in radiological findings. |
|
| ExclusionCriteria |
| Details |
Any history of lower limb joint replacement.
Hip, Knee or ankle surgeries within previous 6 months.
Knee Intra-articular steroid injection within previous 6 months.
Rheumatoid arthritis.
Gout
Fracture in lower limb.
Cognitive deficit.
Uncontrolled hypertension |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
peck strength of quadriceps,
Numeric pain rating scale,
Western Ontario and McMaster universities osteoarthritis index |
On 1st day and after 4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Western Ontario and McMaster universities osteoarthritis index |
On 1st day and after 4 weeks |
|
|
Target Sample Size
|
Total Sample Size="56"
Sample Size from India="56"
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)
|
20/10/2024 |
| 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="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Data will be collecting from the patients coming to exercise department of Government Physiotherapy College Jamnagar. From this data I will extract the number of patients which are coming for the treatment of osteoarthritis of knee joint. Patients who fit selection criteria will be selected. Consent will be taken from patients and patients with osteoarthritis of knee joint will be treated with either quadriceps strengthening with tibial rotation or quadriceps strengthening without tibial rotation along with conventional physical therapy for 5 days a week for 4 weeks. Before and after intervention peak strength of quadriceps, numeric pain rating scale and Western Ontario and McMaster universities osteoarthritis index will be measured. Data will be collected over a period of 8 months. |