| CTRI Number |
CTRI/2024/05/067319 [Registered on: 14/05/2024] Trial Registered Prospectively |
| Last Modified On: |
22/04/2024 |
| 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
|
Strengthening of Transversus abdominis, Lumbar Multifidus and Quadratus Lumborum Muscles on Pain, Strength, and Mobility in patients with Knee Arthritis |
|
Scientific Title of Study
|
Effect of Strengthening in transversus abdominis, Lumbar Multifidus and Quadratus Lumborum on pain, strength and function with knee osteoarthritis : A randomized controlled trial |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Nikita Bhusari |
| Designation |
PG Student |
| Affiliation |
Ravi Nair Physiotherapy College, Datta Meghe Institute of Higher Education and Research (DU), Wardha |
| Address |
Department of Musculoskeletal Physiotherapy, Ravi Nair Physiotherapy College, Datta Meghe Institute of Higher Education and Research(DU)
Wardha
MAHARASHTRA
442001
India |
| Phone |
9422812639 |
| Fax |
|
| Email |
nikitapbhusari@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Subrat Samal |
| Designation |
Associate Professor |
| Affiliation |
Ravi Nair Physiotherapy College, Datta Meghe Institute of Higher Education and Research (DU), Wardha |
| Address |
Department of Musculoskeletal Physiotherapy, Ravi Nair Physiotherapy College, Datta Meghe Institute of Higher Education and Research(DU)
Wardha
MAHARASHTRA
442001
India |
| Phone |
442001 |
| Fax |
|
| Email |
research4subrat@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Nikita Bhusari |
| Designation |
PG Student |
| Affiliation |
Ravi Nair Physiotherapy College, Datta Meghe Institute of Higher Education and Research (DU), Wardha |
| Address |
Department of Musculoskeletal Physiotherapy, Ravi Nair Physiotherapy College, Datta Meghe Institute of Higher Education and Research(DU)
Wardha
MAHARASHTRA
442001
India |
| Phone |
94422812639 |
| Fax |
|
| Email |
nikitapbhusari@gmail.com |
|
|
Source of Monetary or Material Support
|
| Ravi Nair Physiotherapy College, Acharya Vinoba Bhave Rural Hospital, Datta Meghe Institute Of Higher Education And Research [Deemed To Be University], Sawangi Meghe Wardha, Maharashtra, India. |
|
|
Primary Sponsor
|
| Name |
Ravi Nair Physiotherapy College, Datta Meghe Institute of Higher Education and Research (DU) |
| Address |
Ravi Nair Physiotherapy College, Datta Meghe Institute of Higher Education and Research (DU) |
| 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 |
| Nikita Bhusari |
Acharya Vinoba Bhave Rural Hospital, Ravi Nair Physiotherapy College |
In Patient Department Orthopedic Ward, OPD Department Of Musculoskeletal Physiotherapy, Sawangi Meghe
Wardha
MAHARASHTRA |
9422812639
nikitapbhusari@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Datta Meghe Institute of Higher Education and Research [Deemed to be University], INSTITUTE OF ETHICS COMMITTEE |
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 |
Group I (Experimental Group) will receive strengthening of transverse abdominis, Lumbar multifidus muscle and quadratus lumborum with conventional exercises. |
• Exercises will be instructed as previous recommendation.
• The first session will be given individually for subjects assigned to this group that will last for 30-45 minute.
• Initially exercises with low intensity for local stabilizing muscles will be initially administered with isometric contractions.
• The holding time and the number of contractions will be increased progressively in these positions up to 10 contractions repetitions x 10 sec duration each 1st and 2nd week.
|
| Comparator Agent |
Group II (Conventional Group) will receive Conventional exercises. |
Static Quadriceps- 10 times with 10 secs rest between each repetition
(progression of exercise will be done by increasing duration of contraction and number of repetition.)
VMO strengthening- 10 times with 10 secs rest between each repetition.
(progression of exercise will be done by increasing duration of contraction and number of repetition)
One Leg Balance- 5 repetition is done with 10 sec rest in between each repetition.
(progression was done by increasing repetition and time duration in that position)
Forward Lunges- 5 repetitions with 5 sec hold position for both leg
Back extension exercise- 5 repetitions with 5 sec hold
Pelvic bridging- 5 repetitions with 5 sec hold |
|
|
Inclusion Criteria
|
| Age From |
50.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients with diagnosed case of OA knee (Grade 1 and Grade 2)
Patients who have pain on NPRS 6 or less.
Subjects with unilateral Knee Osteoarthritis
Both Genders are included.
Patients without any deformity.
|
|
| ExclusionCriteria |
| Details |
Patients with any inflammatory or other locomotor disease.
Any significant peripheral and CNS disease.
Patients with bone tumor, infection and fracture knee.
Patients under corticosteroid.
Involvement of proximal hip and distal ankle.
Grade 3 and 4 OA patients.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Numerical pain rating scale
WOMAC scale |
Baseline and after 4 weeks
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Muscle Strength-Pressure biofeedback unit
Static knee loading |
Baseline and after 4 weeks |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
25/05/2024 |
| 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
|
The study aims to find out the effectiveness of strengthening in transversus abdominis, lumbar multifidus and quadratus lumborum on pain, strength and function in patients with osteoarthritis knee by using pressure biofeedback device. The randomized controlled trial involves 30 patients having knee osteoarthritis aged 50-65 years, with half receiving Strengthening of Lumbar multifidus, transverse abdominis and quadratus lumborum with conventional exercises and the other half receiving conventional exercises alone. Pre- assessment will be done on 0th day using pressure biofeedback device to evaluate the activity of Transverse Abdominis, Lumbar Multifidus and quadratus lumborum. WOMAC score for function and NPRS scale for pain. Post assessment will be done on 4th week using pressure biofeedback device to evaluate the activity of muscle Transverse abdominis, Lumbar multifidus and quadratus lumborum, WOMAC score for function and NPRS scale for pain. Distribution of weight will be assessed by using weight machine by allowing patient to stand on both machines by placing both feets on two different machines. Through this study, it will be able to create a strengthening regimen that can be given to individuals with knee osteoarthritis to improve their physical well-being. As an addition to conventional treatment, these training programmes would be highly effective in these patients. |