| CTRI Number |
CTRI/2024/06/069525 [Registered on: 26/06/2024] Trial Registered Prospectively |
| Last Modified On: |
25/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
Finding the effects of long term knee movement treatment technique in sports persons with knee pain |
|
Scientific Title of Study
|
Long term combined effect of mulligan patellar mobilization and tibiofemoral mobilization in athletes with patellofemoral pain syndrome:a single group 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 |
Mansi P Kulkarni |
| Designation |
Post Graduate Student |
| Affiliation |
SDM College Of Physiotherapy |
| Address |
OPD NO.05 Orthophysiotherapy Department Shri Dharmasthala Manjunatheshwara College Of Medical Science and Hospital, Manjushree Nagar Sattur, Dharwad.
Dharwad
KARNATAKA 580009
Dharwad
KARNATAKA
580009
India |
| Phone |
7259347086 |
| Fax |
|
| Email |
kulkarnipmansi146@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Mansi P Kulkarni |
| Designation |
Post Graduate Student |
| Affiliation |
SDM College Of Physiotherapy |
| Address |
OPD NO.05 Orthophysiotherapy Department Shri Dharmasthala Manjunatheshwara College Of Medical Science and Hospital, Manjushree Nagar Sattur, Dharwad.
Dharwad
KARNATAKA 580009
Dharwad
KARNATAKA
580009
India |
| Phone |
7259347086 |
| Fax |
|
| Email |
kulkarnipmansi146@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ravi Savadatti |
| Designation |
Professor and PG Guide |
| Affiliation |
SDM College Of Physiotherapy |
| Address |
OPD NO.05 Orthophysiotherapy Department Shri Dharmasthala Manjunatheshwara College Of Medical Science and Hospital, Manjushree Nagar Sattur, Dharwad.
Dharwad
KARNATAKA 580009
Dharwad
KARNATAKA
580009
India |
| Phone |
9606528129 |
| Fax |
|
| Email |
raviraj09199@gmail.com |
|
|
Source of Monetary or Material Support
|
| OPD NO.05 Orthophysiotherapy Department Shri Dharmasthala Manjunatheshwara College Of Medical Science and Hospital, Manjushree Nagar Sattur, Dharwad.
Dharwad
KARNATAKA 580009
India
|
|
|
Primary Sponsor
|
| Name |
Mansi P Kulkarni |
| Address |
OPD NO.05 Orthophysiotherapy Department Shri Dharmasthala Manjunatheshwara College Of Medical Science and Hospital, Manjushree Nagar Sattur, Dharwad.
Dharwad
KARNATAKA 580009
Physiotherapy, Sattur, Dharwad.
Dharwad
KARNATAKA
580009 |
| Type of Sponsor |
Other [] |
|
|
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 Mansi P Kulkarni |
SDM College Of Medical Sciences and hospital |
OPD NO.05 Orthophysiotherapy Department Shri Dharmasthala Manjunatheshwara College Of Medical Science and Hospital, Manjushree Nagar Sattur, Dharwad.
Dharwad
KARNATAKA 580009
Physiotherapy, Sattur, Dharwad.
Dharwad
KARNATAKA
Dharwad
KARNATAKA |
7259347086
kulkarnipmansi146@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SDM college of medical sciences and hospital Institutional Ethics Commitee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M222||Patellofemoral disorders, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Mulligan patellar mobilization and tibiofemoral mobilization |
Treatment protocol:
a) Tibiofemoral mobilization
Patient position:- supine position with knee flexion in
approximately 45º according to patient comfort.
Therapist’s position: therapist will be in a standing
position facing towards the patient
For medial glide MWM the palmar aspect of the right
hand on the upper aspect of the leg (distal to knee) and
left hand on the lower aspect of the thigh (proximal to
knee). Then medial glide is applied to the knee and the
patient is asked to perform knee flexion and extension
Maintaining the medial glide throughout the motion
For medial rotations movement with mobilization grasp
the upper aspect of the tibia with both the hands (thenar
aspect posteriorly and fingers anteriorly) tibia is rotated
medially and patient is asked to flex and extend the knee
while maintaining the medial rotation glide throughout
the motion
b) patellar mobilization
patient position: supine lying and knee extended
therapist’s position: standing or sitting beside the patients
leg.
1.The knee should be supported with one hand.
2. Gentle pressure should be applied to the patella with
the other hand(thumb or fingers).
3. Glides should be given to the patella (superiorly and
inferiorly)
4. Medial and lateral glides can also be performed based
on the patients need.
5. Patient is asked to perform flexion and extension
maintaining the glide throughout the movement.
Duration of the intervention: 4 sessions per week for 2 weeks
(Each session will be of approximately 10-15 minutes)
10 repetitions x 3 sets (1 min resting time
between the sets)
Duration of glide: 6sec – 7sec |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
a. Sports participants in the Age group of 18-30 years
b. Either gender
c. Pain between ≥3 in NPRS.
d. Diagnosis of anterior knee pain from last 2 months(unilateral/
bilateral)
e. Lateral shift of patella, anterior knee or retro patellar pain
f. Agreed to participate in the study
g. Patients referred by orthopedics department with PFPS |
|
| ExclusionCriteria |
| Details |
a. Meniscus tear
b. Bursitis, ligament injury, patellar tendon injury
c. Frequent subluxation
d. Lower extremity surgery
e. Diagnosed with neurological and neuromuscular disorder |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
KUJALA SCALE/AKPS( Anterior knee pain scale)
NPRS(Numerical pain rating scale)
GROC(Global rating of change)
ROM(Range of motion) |
Week 0 and after 2 weeks. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="68"
Sample Size from India="68"
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)
|
10/07/2024 |
| 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 Applicable |
| 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
|
Patellofemoral pain syndrome is an umbrella term used for pain
arising from the patellofemoral joint itself, or adjacent soft tissues.
Patellofemoral pain syndrome (PFPS) is a pattern of slowly
developing diffused pain in the knee that is typically made worse by
standing after sitting, walking, stairs, deep squatting, kneeling, and
extended sitting (movie sign). PFPS is one of the most prevalent
musculoskeletal disorders in teenagers and young adults, with a
reported 25% incidence in the general population.1
It is related to a
breakdown in the mechanical forces that operate between the femur
and patella. Patients often report diffuse anterior knee pain(AKP)
increases the compressive stresses across the patellofemoral joint2 An
estimated 7% to 40% of teenagers and active young people suffer
from this somewhat prevalent illness that is seen in the clinical
setting3 Excessive load or extended repetitive motion in the
patellofemoral joint (PFJ) is the cause of this pain and dysfunction.
An additional typical cause of PFS discomfort foot problems, knee
ligament injuries, and a decrease in the strength of the hip abductors
and an increase in the power of the adduction muscles4 Pain
persistence or development may be influenced by impairments in soft
tissue and joint motion. Hypomobility, for example increasing lateral
joint loading during knee flexion, such as a lack of medial PFJ gliding
or a decrease in the extensibility of the tensor fascialata, iliotibial
tract, or lateral retinaculum. Improper joint loading may continue if mobility limitations are not addressed.5 The patella moves within the
trochlea groove, which is controlled by both active and static
stabilizers in the patellofemoral joint such as the patellar tendon,
quadriceps tendon, and the surrounding soft tissues, such as the
iliotibial band, which act as stabilizing forces4
In the general
population, reports indicate that the annual prevalence of PFPS is
29% in teenagers and 23% in adults5
It is common for half of PFP
patients to have an inaccurate diagnosis of patellar maltracking based
on the patella’s lateral translation during complete knee extension6The
largest sesamoid bone in the body, the patella serves as a pivot to
increase the quadriceps’ mechanical advantage in fully extended knee
Because there is a lack of articular congruency, the patella can glide more freely because it does not articulate with the femoral condyles.
At 20 to 30 degrees of knee flexion, the femoral condyle is first made
touch with the inferior patellar facet. The patella and femoral
condyles become more congruent as flexion proceeds, with the largest
contact area occurring between 60 and 90 degrees of knee flexion.
The patellofemoral joint (PFJ) experiences a significant increase in
compressive pressure during weight-bearing duties, even though the
contact between the patella and femur increases with knee flexion.
According to earlier research, PFJ loads can reach 1.3 times body
weight.7
Joint mobilization has been demonstrated to provide a variety
of benefits, including bettering pain modulation, reducing broad
hyperalgesia, and improving mobility in patients with chronic knee
pain. It has also been found to improve psychological outcomes5A
prevalent cause of "anterior knee pain," patellofemoral pain syndrome
(PFPS) primarily affects young women without obvious pathological
alterations in the articular cartilage or an elevated Q-angle.8Many
sportsmen restrict their sporting activity due to PFPS
symptoms.8Research has demonstrated that youth athletes had
enhanced quality of life, increased brain cortical excitability,
enhanced long-term neural adaptation mechanisms, and enhanced
visuospatial skills. Despite these conclusions, recent research
indicates that, in comparison to multisport athletes, sport
specialization in female teenagers is linked to an increased incidence of PFPS.9Up to 40% of clinical visits for knee issues and about 25%–
30% of all injuries observed in a sports medicine clinic are said to be
related to (patellofemoral pain) PFP. PFP is responsible with 33% and
18% of all knee injuries in athletes that are male and female,
respectively. It is also one of the most typical overuse injuries in a
variety of sports, including running, basketball, and volleyball. In
74% of patients, PFP symptoms may result in a reduction in athletic
participation or the abandonment of sports altogether.10As much as
44% of long-distance triathlete competitors report having knee
overuse injuries, making them the most common injury among
athletes. When it comes to triathlon athletes, PFPS is perhaps the most
prevalent subgroup of overuse knee pain. Physiological overloading
with or without "mal-alignment" is a major element in the diverse and
multiple etiology. |