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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05924607
Other study ID # REC/RCR & AHS/23/0101
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date November 14, 2022
Est. completion date August 30, 2023

Study information

Verified date June 2023
Source Riphah International University
Contact Imran Amjad, Phd
Phone 03324390125
Email imran.amjad@.edu.pk
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 42
Est. completion date August 30, 2023
Est. primary completion date August 24, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 40 Years
Eligibility 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 Design


Intervention

Other:
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
Targeted VMO strengthening
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

Locations

Country Name City State
Pakistan Ittefaq Hospital Lahore Punjab

Sponsors (1)

Lead Sponsor Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Baseline to 6th week
Primary 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. Baseline to 6th week
Primary Muscle strength Sphygmomanometer is used to measure muscle strength. higher readings on sphygmomanometer represents better muscle strength. Baseline to 6th week
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