- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05924607
Clamshells Exercise and Vastrus Medialis Oblique Strengthening Exercise on Patellofemoral Pain Syndrome
Comparative Effects of Clamshells Exercise and Vastrus Medialis Oblique Strengthening Exercise on Patellofemoral Pain Syndrome
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Imran Amjad, Phd
- Phone Number: 03324390125
- Email: imran.amjad@.edu.pk
Study Locations
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Punjab
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Lahore, Punjab, Pakistan, 54000
- Recruiting
- Ittefaq Hospital
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Contact:
- sidra khan, MSNMPT
- Phone Number: 03004132720
- Email: sidra_khan5544@yahoo.com
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Standard clamshells method
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 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
|
|
Experimental: 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
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain intensity
Time Frame: Baseline to 6th week
|
numeric pain rating scale(NPRS) is used to measure intensity of pain.Score ranges from 0-10.Higher values mean greater level o pain.
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Baseline to 6th week
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Functional disability
Time Frame: Baseline to 6th week
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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.
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Baseline to 6th week
|
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Muscle strength
Time Frame: Baseline to 6th week
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Sphygmomanometer is used to measure muscle strength.
higher readings on sphygmomanometer represents better muscle strength.
|
Baseline to 6th week
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Dr.Rabiya Noor, Phd, Riphah International University
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- REC/RCR & AHS/23/0101
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Patellofemoral Pain Syndrome
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University of North Carolina, Chapel HillCanadian Institutes of Health Research (CIHR)CompletedPatellofemoral Pain Syndrome | Patellofemoral Pain (PFPS) | Patellofemoral Pain | Patellofemoral Pain, PFPUnited States
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