| CTRI Number |
CTRI/2024/07/071606 [Registered on: 30/07/2024] Trial Registered Prospectively |
| Last Modified On: |
22/07/2024 |
| 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
|
To assess the effectiveness of knee muscle stretching along with routine exercise program in knee arthritis patients |
|
Scientific Title of Study
|
Effectiveness of Addition of Rectus Femoris Stretching to Conventional Exercise Program among Knee Osteoarthritis Patients |
| 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 Swati Paranjape |
| Designation |
Assistant Professor |
| Affiliation |
Seth G S Medical College, KEM Hospital |
| Address |
Physiotherapy Department, Seth G S Medical College, Parel, Mumbai
Mumbai
MAHARASHTRA
400012
India |
| Phone |
02224107000 |
| Fax |
|
| Email |
swati.paranjape@kem.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nikita Kamble PT |
| Designation |
Post Graduate Student |
| Affiliation |
Seth G S Medical College, KEM Hospital |
| Address |
Physiotherapy Department, Seth G S Medical College, Parel, Mumbai
Mumbai
MAHARASHTRA
400012
India |
| Phone |
02224107000 |
| Fax |
|
| Email |
nikitakamble2000@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nikita Kamble PT |
| Designation |
Post Graduate Student |
| Affiliation |
Seth G S Medical College, KEM Hospital |
| Address |
Physiotherapy Department, Seth G S Medical College, Parel, Mumbai
MAHARASHTRA
400012
India |
| Phone |
02224107000 |
| Fax |
|
| Email |
nikitakamble2000@gmail.com |
|
|
Source of Monetary or Material Support
|
| Seth G S Medical College,& KEM Hospital, Parel, Mumbai |
|
|
Primary Sponsor
|
| Name |
Seth G S Medical College |
| Address |
Seth G S Medical College, Parel, Mumbai 400012 |
| 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 Nikita Kamble |
Seth G S Medical College, and KEM Hospital |
Physiotherapy OPD Number 402, Orthopedic Centre, Opp Tata Hospital, Parel, Mumbai
Mumbai
MAHARASHTRA |
02224107000
nikitakamble2000@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee IEC III, Relating to Biomedical and Health Research (BHR) |
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 Exercise Program |
Application of stretching of IT band, knee range of motion exercises, static quadriceps, static hamstrings, VMO strengthening, dynamic quadriceps and straight leg raise. Program will be given for 3 weeks thrice per week. |
| Intervention |
Conventional Exercise Program (CEP)+ Rectus Femoris Stretching |
Along with CEP rectus stretching is added in this group. The patient lies supine with the knees bent over the end or edge of the examining table. The patient flexes one knee onto the chest and holds it.The angle of the test knee should remain at 90 degrees when the opposite knee is flexed to the chest, while the examiner passively pushes the test leg down on at distal aspect of the femur. The program will be given for 3 weeks thrice per week. |
|
|
Inclusion Criteria
|
| Age From |
50.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
1. Knee osteoarthritis patients fulfilling the American College of Rheumatology clinical
classification criteria.
2. Both Males and Females willing to participate.
3. Knee OA patients with rectus femoris tightness.
4. Numerical pain rating score of more than or equal to 3 out of 10 and lesser than or equal to 7 out of 10 on all the activities involving
mobility and weight bearing.
5. Unilateral or bilateral knee OA. |
|
| ExclusionCriteria |
| Details |
1. Numerical pain rating score of greater than or equal to 8 out of 10
2. Musculoskeletal injury.
3. Peripheral vascular disease.
4. Any Neurological condition.
5. Cognitive impairment.
6. Major medical and surgical history.
7. Congenital or acquired deformities of spine or lower limb.
8. Uncorrected visual and auditory impairments. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.PAIN: The NRS as an 11-point scale with the end points being the extremes of no pain
and pain being the worst pain.
2.RECTUS FEMORIS FLEXIBILITY ASSESSMENT: Modified Thomas test
3.GAIT SPEED ASSESSMENT: 10 Meter walk test |
1.Baseline
2.Third Visit
3.Sixth Visit
4. Nineth Visit |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="24"
Sample Size from India="24"
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)
|
05/08/2024 |
| 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 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
|
Knee osteoarthritis
(OA) is a most common degenerative joint disease that causes pain and joint
dysfunction in elderly. It impairs physical activity and quality of life and
contributes significantly to the global burden of disease. Patients with
knee OA are more likely to have tightness in the rectus femoris muscle, which
is the only two joint muscle in the knee extensors group. Thereby limiting the knee range of motion and
exacerbating symptoms such as pain, rectus femoris length and gait speed. Research
specifically focusing on the effectiveness of rectus femoris stretching in knee
OA patients, has found to be limited on the population of India. There appears
to be gap in scientific literature regarding the said approach and its impact in
addition to conventional exercise program in individuals with knee OA. Further
research is needed to throw light to the possible effects and results of
incorporating rectus femoris stretching to conventional exercise program for
this population. Hence, the study titled “effectiveness of addition of rectus
femoris stretching to conventional exercise program among knee OA patients†is
designed. Total 24 participants having knee OA with rectus femoris
tightness will be included in the study. Participants will be recruited into
the study by convenient sampling method and according to the inclusion and
exclusion criteria. Participants will be assessed for pain intensity using
numerical rating scale, rectus femoris length will be assessed using universal
goniometer and gait speed using 10-meter walk test. Conventional exercise
program and addition of rectus femoris stretching in to conventional exercise
program will be allotted to control and study group respectively by chit
method. Pain, rectus femoris length and gait speed will be assessed on 1st
visit pre-treatment followed by 3rd, 6th and 9th visit post treatment sessions.
Total 9 follow up sessions will be taken - 3 days/week for 3 weeks, study
duration for each session will be for 30 minutes. Descriptive analysis of data
will be performed and appropriate parametric and non-parametric tests will be
used based on distribution of sample. |