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Clamshells Exercise and Vastrus Medialis Oblique Strengthening Exercise on Patellofemoral Pain Syndrome

Primary Purpose

Patellofemoral Pain Syndrome

Status
Recruiting
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Standard clamshells method
Targeted VMO strengthening
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Patellofemoral Pain Syndrome

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Age 18 to 40years Both Genders (male & female) Unilateral or bilateral knee pain for at least 1-3 month, Pain provoked by at least 3 functional activities ( ascending/descending stairs, kneeling, jumping, running, squatting,hopping,prolonged sitting) Average NPRS score above 3 out of 10 during previous week. Knee pain on stepping down from 20cm step height. Exclusion Criteria Previous history of patellar subluxation or dislocation Knee surgery within previous year History of knee joint pathologies ( meniscus,ligament injuries,) Any fracture of lower extremity Massive effusion/any abnormal deformity of knee joint.

Sites / Locations

  • Ittefaq HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Standard clamshells method

Targeted VMO strengthening

Arm Description

The patient is asked to lie in a side-lying position with the weak limb up, both hips flexed at 45°, the knees flexed at 90°, and neither the feet nor back not in contact with the wall. Keeping both their heels and the first metatarsal head together, the patient separated their knees and rotated the weak limb upward. The patients is instructed not to tip it backward and to hold the pelvis in a neutral position.Common treatment will be given to each patient includes hot pack for 10 minutes and knee isometric contraction exercises and SLR( 3-5 sets of 10 repetitions)

The patient is asked to lie in a supine lying position with arm next to the body. After that asked the patient to perform SLR exercise in an external hip rotation with the simultaneous contraction of the ankle dorsiflexors. Common treatment will be given to each patient includes hot pack for 10 minutes and knee isometric contraction exercises and SLR( 3-5 sets of 10 repetitions

Outcomes

Primary Outcome Measures

Pain intensity
numeric pain rating scale(NPRS) is used to measure intensity of pain.Score ranges from 0-10.Higher values mean greater level o pain.
Functional disability
The lower Extremity Functional Scale (LEFS) is used to measure the functional status of the lower extremity. score ranges from 0-80. lower values mean greater functional limitation.
Muscle strength
Sphygmomanometer is used to measure muscle strength. higher readings on sphygmomanometer represents better muscle strength.

Secondary Outcome Measures

Full Information

First Posted
April 18, 2023
Last Updated
June 26, 2023
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT05924607
Brief Title
Clamshells Exercise and Vastrus Medialis Oblique Strengthening Exercise on Patellofemoral Pain Syndrome
Official Title
Comparative Effects of Clamshells Exercise and Vastrus Medialis Oblique Strengthening Exercise on Patellofemoral Pain Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 14, 2022 (Actual)
Primary Completion Date
August 24, 2023 (Anticipated)
Study Completion Date
August 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
PFPS, also known as patellofemoral pain syndrome, is a prevalent musculoskeletal condition that primarily affects adolescents and young adults. When engaging in various activities, such as stair climbing, running, jumping, kneeling, or prolonged sitting, it is characterized by aching pain in the peripatellar region. Any disruption of these would result in abnormal PFJ overloading. Normal patellar tracking on the trochlea groove relies on the coordination and balance of many structures, including soft tissues, muscles, tendons, ligaments, and the shape of articular surfaces around the knee joint. Research in a variety of fields has received support the therapeutic exercise known as "clamshells" for stabilizing the pelvis by strengthening the hip abductors and external rotators.VMO strengthening exercises are also essential in keeping the patella in the trochlear groove and lowering the lateral vector force on the patellofemoral joint. This research aims to evaluate the effects of clamshells exercise and Vastrus medialis oblique strengthening exercise in patients with Patellofemoral pain syndrome. The study would be randomized clinical trial. Total fourty two subjects will be assigned randomly by using lottery method into two groups. Group A will be given clamshell exercise with baseline treatment while Group B will receive targeted vastrus medialis oblique strengthening exercise with baseline treatment. After confirmation of diagnosis with physical examination as well as zohlar's test /20 cm step down test are recommended. Numeric pain rating scale (NPRS) and Lower extremity functional scale (LEFS) would be used as an outcome measure tools for pain and functional limitation respectively. Measurements will be taken at (Baseline and at the end of treatment session). The collected data will be analyzed in Statistical Package for the Social Sciences (SPSS) 25.0. Parametric/non-parametric tests will be applied after testing normality of data.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Patellofemoral Pain Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
42 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Standard clamshells method
Arm Type
Experimental
Arm Description
The patient is asked to lie in a side-lying position with the weak limb up, both hips flexed at 45°, the knees flexed at 90°, and neither the feet nor back not in contact with the wall. Keeping both their heels and the first metatarsal head together, the patient separated their knees and rotated the weak limb upward. The patients is instructed not to tip it backward and to hold the pelvis in a neutral position.Common treatment will be given to each patient includes hot pack for 10 minutes and knee isometric contraction exercises and SLR( 3-5 sets of 10 repetitions)
Arm Title
Targeted VMO strengthening
Arm Type
Experimental
Arm Description
The patient is asked to lie in a supine lying position with arm next to the body. After that asked the patient to perform SLR exercise in an external hip rotation with the simultaneous contraction of the ankle dorsiflexors. Common treatment will be given to each patient includes hot pack for 10 minutes and knee isometric contraction exercises and SLR( 3-5 sets of 10 repetitions
Intervention Type
Other
Intervention Name(s)
Standard clamshells method
Intervention Description
The patient is asked to lie in a side-lying position with the weak limb up, both hips flexed at 45°, the knees flexed at 90°, and neither the feet nor back not in contact with the wall. Keeping both their heels and the first metatarsal head together, the patient separated their knees and rotated the weak limb upward. The patients is instructed not to tip it backward and to hold the pelvis in a neutral position
Intervention Type
Other
Intervention Name(s)
Targeted VMO strengthening
Intervention Description
Targeted VMO strengthening The patient is asked to lie in a supine lying position with arm next to the body. After that asked the patient to perform SLR exercise in an external hip rotation with the simultaneous contraction of the ankle dorsiflexors. Common treatment will be given to each patient includes hot pack for 10 minutes and knee isometric contraction exercises and SLR( 3-5 sets of 10 repetitions
Primary Outcome Measure Information:
Title
Pain intensity
Description
numeric pain rating scale(NPRS) is used to measure intensity of pain.Score ranges from 0-10.Higher values mean greater level o pain.
Time Frame
Baseline to 6th week
Title
Functional disability
Description
The lower Extremity Functional Scale (LEFS) is used to measure the functional status of the lower extremity. score ranges from 0-80. lower values mean greater functional limitation.
Time Frame
Baseline to 6th week
Title
Muscle strength
Description
Sphygmomanometer is used to measure muscle strength. higher readings on sphygmomanometer represents better muscle strength.
Time Frame
Baseline to 6th week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 18 to 40years Both Genders (male & female) Unilateral or bilateral knee pain for at least 1-3 month, Pain provoked by at least 3 functional activities ( ascending/descending stairs, kneeling, jumping, running, squatting,hopping,prolonged sitting) Average NPRS score above 3 out of 10 during previous week. Knee pain on stepping down from 20cm step height. Exclusion Criteria Previous history of patellar subluxation or dislocation Knee surgery within previous year History of knee joint pathologies ( meniscus,ligament injuries,) Any fracture of lower extremity Massive effusion/any abnormal deformity of knee joint.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Imran Amjad, Phd
Phone
03324390125
Email
imran.amjad@.edu.pk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dr.Rabiya Noor, Phd
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ittefaq Hospital
City
Lahore
State/Province
Punjab
ZIP/Postal Code
54000
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
sidra khan, MSNMPT
Phone
03004132720
Email
sidra_khan5544@yahoo.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31846113
Citation
Hott A, Brox JI, Pripp AH, Juel NG, Liavaag S. Patellofemoral pain: One year results of a randomized trial comparing hip exercise, knee exercise, or free activity. Scand J Med Sci Sports. 2020 Apr;30(4):741-753. doi: 10.1111/sms.13613. Epub 2020 Jan 5.
Results Reference
background
PubMed Identifier
30267667
Citation
Foroughi F, Sobhani S, Yoosefinejad AK, Motealleh A. Added Value of Isolated Core Postural Control Training on Knee Pain and Function in Women With Patellofemoral Pain Syndrome: A Randomized Controlled Trial. Arch Phys Med Rehabil. 2019 Feb;100(2):220-229. doi: 10.1016/j.apmr.2018.08.180. Epub 2018 Sep 26.
Results Reference
background
PubMed Identifier
35253163
Citation
Azab AR, Abdelbasset WK, Basha MA, Mahmoud WS, Elsayed AE, Saleh AK, Elnaggar RK. Incorporation of Pilates-based core strengthening exercises into the rehabilitation protocol for adolescents with patellofemoral pain syndrome: a randomized clinical trial. Eur Rev Med Pharmacol Sci. 2022 Feb;26(4):1091-1100. doi: 10.26355/eurrev_202202_28098.
Results Reference
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Clamshells Exercise and Vastrus Medialis Oblique Strengthening Exercise on Patellofemoral Pain Syndrome

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