| CTRI Number |
CTRI/2019/02/017883 [Registered on: 28/02/2019] Trial Registered Prospectively |
| Last Modified On: |
29/04/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Soft tissue release in recreational runners with anterior knee pain |
|
Scientific Title of Study
|
Effects of fascial manipulation on knee function and pain in recreational runners with patellofemoral pain syndrome: A Randomized Controlled Trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Karthik A |
| Designation |
Master of physiotherapy (MPT) student |
| Affiliation |
Manipal Academy of Higher Education |
| Address |
Upper basement,Department of Physiotherapy, Manipal Hospital,#98,HAL,Old Airport road,Bangalore
Bangalore
KARNATAKA
560017
India |
| Phone |
7904045675 |
| Fax |
|
| Email |
karthikvagai6@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Karvannan H |
| Designation |
Associate Professor |
| Affiliation |
Manipal Academy of Higher Education |
| Address |
Upper basement,Department of Physiotherapy, Manipal Hospital,#98,HAL,Old Airport road,Bangalore
Bangalore
KARNATAKA
560017
India |
| Phone |
9986565966 |
| Fax |
|
| Email |
karvannan.h@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Prem V |
| Designation |
Associate Professor |
| Affiliation |
Manipal Academy of Higher Education |
| Address |
Upper basement,Department of Physiotherapy, Manipal Hospital,#98,HAL,Old Airport road,Bangalore
Bangalore
KARNATAKA
560017
India |
| Phone |
9886647732 |
| Fax |
|
| Email |
prem.v@manipal.edu |
|
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Source of Monetary or Material Support
|
| Department of physiotherapy,School of allied health sciences, Manipal academy of higher education, Manipal
576104 |
|
|
Primary Sponsor
|
| Name |
SOAHS Manipal Academy of Higher Education |
| Address |
Upper basement,Department of Physiotherapy, Manipal Hospital,#98,HAL,Old Airport road,Bangalore |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Karthik A |
Manipal Hospital |
Upper basement,Department of physiotherapy,Manipal hospital, #98,HAL,Old Airport Road, Bangalore
Bangalore
KARNATAKA |
7904045675
karthikvagai6@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Research Committe,School of Allied Health Sciences, Manipal Academy of Higher Education, Manipal |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M222||Patellofemoral disorders, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Fascial manipulation |
Fascial manipulation will be given for total of 10 sessions,2-3 sessions/week with 45 minutes duration of each session.
Based on Steccos fascial manipulation assessment, most densified point of affected limb will be treated. |
| Comparator Agent |
Hip and Knee strengthening exercises |
Strengthening exercises will emphasis on knee and hip muscles.
Exercises will progressed from isometric to non-weight bearing to weight bearing and functional retraining based on the progression of the condition in the 4weeks.
Knee and Hip exercises like
1.Isometric hip abduction in standing
2.Hip abduction in supine lying
3.Hip abduction with slight knee and hip flexion in side lying
4.Hip abduction in side lying
5.Vastus medialis oblique activation
6.Static quadriceps
7.Stretching for lower limb muscles(hamstrings,quadriceps,iliotibial band,gastrocnemius)
8. Straight leg raise in supine
9.Seated knee extension will be given.
Total of 10 sessions,in which 2-3 sessions/week supervised. Each session will be for 45mins for 4weeks.
Using log book and phone calls exercise adherence will be followed on the non supervised days. |
|
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Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
1.Recreational runners
2.Age group of 20-45
3.Runners diagnosed with patellofemoral pain syndrome using clinical test
4.NPRS minimum score greater than or equal to 3 |
|
| ExclusionCriteria |
| Details |
1) Inflammatory diseases
2) Recent injury (ligament or meniscal injury or patella dislocation)
3) Recent history of fall on knee
4) Associated problems - hip pain and low back pain
|
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Method of Generating Random Sequence
|
Other |
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Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Lower extremity functional scale |
Pre intervention and the end of 4th week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NPRS scale |
Pre intervention and the end of 4th week |
| Pressure pain threshold |
Pre intervention and the end of 4th week |
|
|
Target Sample Size
|
Total Sample Size="66"
Sample Size from India="66"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="66" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
11/03/2019 |
| Date of Study Completion (India) |
05/04/2022 |
| 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)?
|
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Brief Summary
|
Patellofemoral pain syndrome is one of the most common injuries in runners. An imbalance forces which are placed on the patella during movement is because of fascial densification, which later leads to patellofemoral pain syndrome. There is a paucity in literature on effect of fascial manipulation on knee function and pain in recreational runners with patellofemoral pain syndrome
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