CTRI Number |
CTRI/2023/10/059073 [Registered on: 25/10/2023] Trial Registered Prospectively |
Last Modified On: |
23/10/2023 |
Post Graduate Thesis |
No |
Type of Trial |
Interventional |
Type of Study
|
Physiotherapy (Not Including YOGA) |
Study Design |
Randomized, Parallel Group, Active Controlled Trial |
Public Title of Study
|
Importance of lumbar core stabilization exercises on pulmonary functions, pain, dynamic balance and functional activities in patients with knee Osteoarthritis |
Scientific Title of Study
|
Effects of lumbar core endurance training and stabilization exercises on pulmonary functions, pain, dynamic balance and functional activities in patients with knee OA |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
MAULIK SHAH |
Designation |
Consultant Physiotherapist |
Affiliation |
Civil Hospital |
Address |
Physiotherapy Department,
Civil Hospital,
Bhagavatpara,
Gondal. Bhagavatpara,Gondal Rajkot GUJARAT 360005 India |
Phone |
9426818495 |
Fax |
|
Email |
maulikshah50@yahoo.com |
|
Details of Contact Person Scientific Query
|
Name |
MAULIK SHAH |
Designation |
Consultant Physiotherapist |
Affiliation |
Civil Hospital |
Address |
Physiotherapy Department,
Civil Hospital,
Gondal Bhagavatpara,Gondal Rajkot GUJARAT 360311 India |
Phone |
9426818495 |
Fax |
|
Email |
maulikshah50@yahoo.com |
|
Details of Contact Person Public Query
|
Name |
MAULIK SHAH |
Designation |
Consultant Physiotherapist |
Affiliation |
Civil Hospital |
Address |
Superintendent office,
Civil Hospital,
Gondal. Bhagavatpara,Gondal Rajkot GUJARAT 360311 India |
Phone |
9426818495 |
Fax |
|
Email |
maulikshah50@yahoo.com |
|
Source of Monetary or Material Support
|
Government Hospital, Bhagvatpara, Gondal , Dist - Rajkot, Gujarat |
|
Primary Sponsor
|
Name |
Government Hospital |
Address |
Government Hospital,
Bhagvatpara,
Gondal , Dist - Rajkot, Gujarat |
Type of Sponsor |
Other [Gujarat Government 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 |
DR Maulik Shah |
Civil Hospital,Gondal |
Physiotherapy Department,Civil Hospital,BhagavatPara,Gondal Rajkot GUJARAT |
9426818495
maulikshah50@yahoo.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 2 |
Name of Committee |
Approval Status |
Local NOC from Civil Hospital Gondal |
Approved |
Shree Giriraj Hospital Research Ethics Commitee |
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 |
Intervention |
TENS, Infrared rays, Ultrasound, Q - Drills Exercises |
1) Ultrasound- 1MHz, 1.2 Watts/cm2 for 5 minutes
2) IR – 10 minutes with comfortable heating
3) TENS for 10 minutes, using modulated mode with comfortable intensity
4) Q- drill exercises(Knee muscles strengthening protocol)
Static quadriceps exercise,
Terminal knee extension,
Straight leg raise,
Hip abductors strengthening,
High sitting quadriceps strengthening.
Frequency: 2 sets of 10 repetitions.
|
Comparator Agent |
TENS, Infrared Rays, Ultrasound, Q - Drills Exercises, Lumbar Core Stability Exercises
|
1) Ultrasound- 1MHz, 1.2 Watts/cm2 for 5 minutes
2) IR – 10 minutes with comfortable heating
3) TENS for 10 minutes, using modulated mode with comfortable intensity
4) Q- drill exercises(Knee muscles strengthening protocol)
Static quadriceps exercise,
Terminal knee extension,
Straight leg raise,
Hip abductors strengthening,
High sitting quadriceps strengthening,
Frequency: 2 sets of 10 repetitions.
lumbar core endurance training:
1. Supine Abdominal Draw In
2. Abdominal Draw In with Heel Slide
3. Abdominal Draw In with Double Knee to Chest
4. Supine Twist
5. Dead Bug exercise
6. Supine Butt Lift with Arms at Side
7. Abdominal Draw In with feet on the ball
Patients would receive treatment 6 days a week for 6 weeks of duration.
|
|
Inclusion Criteria
|
Age From |
40.00 Year(s) |
Age To |
70.00 Year(s) |
Gender |
Both |
Details |
1. Patient referred to physiotherapy department by orthopedician or any medical practioner for Knee OA with kellgren Lawrence classification grade II & grade III from x ray defined by an orthopedician.
2. Patients’ chief complaint is related to pain around the knee joint with difficulties in ADLs like sit to stand, stair climbing etc...
3. Age of patient- 40 years & above
4. Genders : Male & females both are included
5. Patients who are able to comprehend commands
|
|
ExclusionCriteria |
Details |
1.Trauma and neurological condition of lumbosacral spine.
2.Previous surgery over lumbar spine/ hip / knee / ankle
3.Systemic illness like lower extremity vascular disorder
4.Patients with known case of pulmonary disorders
5.History of lower limb fracture
6.Medical red flags
7.Non-cooperative patient
The above stated conditions will be ruled out on the discretion of a Medical Professional.
|
|
Method of Generating Random Sequence
|
Not Applicable |
Method of Concealment
|
Alternation |
Blinding/Masking
|
Participant Blinded |
Primary Outcome
|
Outcome |
TimePoints |
Score with Numeric Pain Rating Scale, Score With Modified WOMAC Scale, Score with Community Balance & Mobility Scale, Litre with FEV1, Litre with FVC, % with FEV1/FVC |
NPRS, Modified WOMAC scale score, Value of FEV1 & FVC will be measured at the first day of treatment & 6 weeks of treatment. |
|
Secondary Outcome
|
Outcome |
TimePoints |
Sociodemographic Charecteristics Questionnaire, Visual analogue scale to evaluate Fatigue Severity, Visual Analogue Scale, Beck depresson inventory. |
Follow up would be taken at 6 months regular intervals for 3 years. |
|
Target Sample Size
|
Total Sample Size="310" Sample Size from India="310"
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 3 |
Date of First Enrollment (India)
|
06/11/2023 |
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="9" Days="0" |
Recruitment Status of Trial (Global)
|
Open to Recruitment |
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
|
Osteoarthritis (OA) is a
degenerative joint disease & the knee is the most common site for OA with the prevalence varying from 26% to 63% depending on age and
gender. Knee OA is a multifactorial
disorder resulting from several contributing factors including trauma,
anatomical factors, biomechanical muscle imbalance, and occupational hazards.
Few studies have
focused on the contribution of core stability to dynamic knee joint stability,
mobility & function. The core of the body provides a foundation upon which
the muscles of the lower extremities produce or resist force. The core is constructively a muscular box in which diaphragm is
on the top, the pelvic floor and hip girdle musculature as the bottom,
abdominals in the anterior, and the paraspinal and gluteal muscles behind. All
the hip musculatures have their origins in pelvic and lumbar regions s o that
the compromised core can be responsible for an unstable proximal base and
quality muscle recruitments for stability as well as mobility.
There is
always a vicious cycle related to weakness of core stabilizers/ spinal
stabilizers and lower extremity muscles. Initially there would be weakness of
lower limb muscles that overburdened core muscles due to length – tension
relationship between them.Decreased core stability and muscular synergism of the trunk and hip
stabilizers may affect performance in ADLs as well affect balance &
mobility.
The weakening of core muscles in
knee OA patients also affects their primary and secondary respiratory muscles. Strong
Abdominal muscle contraction is needed to increase intra-abdominal pressure,
disÂcharges the air to the outside of the diaphragm, and is necessary for
bucking for airway clearance. Weak abdominals used to affect FEV1 & FVC
value, thus affecting respiratory functions.
NEED OF THE STUDY
In spite of many researches done
on proximal stability training i.e. core and hip strengthening
for prevention of lower extremity
injuries and also studies done on deficits of neuromuscular control of the trunk
to predict risks of knee injuries, there are no studies correlating the core
and lower limb muscles strength, functional activity level as well as
correlation between core strength and pulmonary functions influencing the most common
musculoskeletal condition i.e. knee osteoarthritis. Therefore, the purpose of
our study is to find out Effects of lumbar core
endurance training and stabilization exercises on pulmonary function, pain,
dynamic balance and functional activities in patients with knee OA.
AIM & OBJECTIVES
The aim of the present work is to
study the Effects of lumbar core endurance
training and stabilization exercises on pulmonary function, pain,
dynamic balance and functional
activities in patients with knee OA.
OBJECTIVES
·
To study the additive
effect of lumbar core endurance training and
stabilization exercises on pulmonary function, pain, dynamic balance and functional
activities in patients with knee OA.
·
To study the
effect of conventional physiotherapy treatment on
pulmonary function, pain, dynamic balance and functional activities in patients
with knee OA.
·
To compare the
effect of lumbar core endurance training and
stabilization exercises and
conventional physiotherapy on pulmonary function,
pain, dynamic balance and functional activities in patients with knee OA. |