| CTRI Number |
CTRI/2018/02/011796 [Registered on: 09/02/2018] Trial Registered Retrospectively |
| Last Modified On: |
16/11/2019 |
| 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
|
Efficacy of the Functional Mobilization Approach in Young Adults with Anterior Knee Pain: A Randomized Clinical Trial |
|
Scientific Title of Study
|
"Efficacy of the Functional Mobilization Approach on Subjects with Patellofemoral Pain Syndrome: A Randomized Clinical Trial" |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Lili Kalumyana Silumesii |
| Designation |
PG Student, Physiotherapy (Orthopaedics) |
| Affiliation |
Sharda Univeristy |
| Address |
D - 179, Sector 105, Noida
Gautam Buddha Nagar
UTTAR PRADESH
201301
India |
| Phone |
8800928706 |
| Fax |
|
| Email |
silumesiilili@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Supriya Awasthi |
| Designation |
Assistant Professor |
| Affiliation |
Sharda Univeristy |
| Address |
Sharda University
Gautam Buddha Nagar
UTTAR PRADESH
201306
India |
| Phone |
8527452565 |
| Fax |
|
| Email |
supriya.awasthi@sharda.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Lili Kalumyana Silumesii |
| Designation |
PG Student, Physiotherapy (Orthopaedics) |
| Affiliation |
Sharda Univeristy |
| Address |
D - 179, Sector 105, Noida
Gautam Buddha Nagar
UTTAR PRADESH
201301
India |
| Phone |
8800928706 |
| Fax |
|
| Email |
silumesiilili@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sharda University and Hospital
Plot Number 32 - 34
Knowledge Park III
Greater Noida
Uttar Pradesh
201306 |
|
|
Primary Sponsor
|
| Name |
Sharda University and Hospital |
| Address |
Plot Number 32 to 34
Knowledge Park III
Greater Noida
UP
201306 |
| Type of Sponsor |
Other [Private University and Hospital and Research Institution] |
|
|
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 |
| Lili Kalumyana Silumesii |
Sharda Hospital |
Plot number 32 - 34
Knowledge Park III
Greater Noida
Department of Physiotherapy,
First Floor,
F Block
Gautam Buddha Nagar
UTTAR PRADESH |
8800928706
silumesiilili@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M170||Bilateral primary osteoarthritis of knee, Patellofemoral pain syndrome due to foot hyperpronation, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Full length medial wedge insole |
The medial raise provides an increase in the height of the medial side of the foot (arch). It increases control of the medial aspect of the rear foot and provides correction and stabilization.
The metatarsal raise supports the metatarsal area and redistributes weight away from the ball of the foot. |
| Intervention |
Functional manual therapy of foot and ankle |
Three dimensional functional manual therapy approach (A combination of Joint mobilization, Proprioceptive Neuromuscular Facilitation, and Soft tissue manipulation). This improves performance by facilitating 3-D function to the joints, soft tissues and neuromuscular system.
It addresses the neuromuscular system which provides muscular initiation, strength and endurance, creating both stability and mobility. It also addresses the mechanical system which determines optimal alignment and functional capacity as well as motor control which integrates both the centrally mediated automatic patterns to produce coordinated, purposeful and automatic activities.
|
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Both |
| Details |
1.Clinically diagnosed cases of patellofemoral pain syndrome
2. Presence of unilateral or bilateral foot hyperpronation
3. Duration of PFPS must be more than three weeks (chronic) |
|
| ExclusionCriteria |
| Details |
1.Defined injury or pathological conditions of the knee and foot structures (bursitis, tendinopathies, ligament sprains or instability, menisci injuries, dislocations)
2. History of ankle and/or foot surgery
3.Severe or advanced knee osteoarthritis diagnosed based on clinical and radiological assessment
4. Autoimmune diseases such as rheumatoid arthritis or systemic lupus erythematosus
5. Leg length discrepancy of more than 1 inch
6. Previous physiotherapy treatment (such as exercise therapy, orthosis, mobilization) in the past 12 months
7. Pregnancy |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Pain using the Numeric Pain Rating Scale (0 to 10. Lower scores represent better results)
2. Foot posture using the Foot Posture Index. Positive values indicate hyperpronation
3. Functional status of the lower extremity using the Lower Extremity Functional Scale with scores from 0 to 80. Higher scores represent better results. |
Scores taken on first day and on last day (after three months)
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Functional Tests
1. Squatting with ability to keep heels on floor
2. Bilateral heel standing
3. Bilateral toe standing |
Scores taken on first day and on last day (after three months) |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
31/07/2016 |
| Date of Study Completion (India) |
24/03/2017 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Foot hyperpronation is an abnormal inward rotation of the subtalar joint. Its relation to patellofemoral pain syndrome and was the focus of this study. This study employed a three dimensional functional manual therapy approach (A combination of Functional joint mobilization, Proprioceptive Neuromuscular Facilitation, and functional soft tissue mobilization) to treat and adjust both soft and bony tissue involved and the use of full length medial wedge insoles. Aim and objectives: - To investigate the clinical efficacy of functional manual therapy approach of foot and ankle along with routine exercises with respect to pain and function in these subjects. - To find out if there’s a significant difference in pain and function with regard to using functional manual therapy of foot and ankle as treatment for patellofemoral pain syndrome - To improve knee pain and lower limb function in individuals with patellofemoral pain syndrome - To compare the clinical efficacy of functional manual therapy with full flange medial raise insoles in these subjects Null Hypothesis: Functional manual therapy of foot and ankle will not improve pain and function in young adults with patellofemoral pain syndrome. Alternate Hypothesis: Functional manual therapy of foot and ankle will improve pain and function in young adults with patellofemoral pain syndrome. At the end of the study, the null hypothesis was rejected. |