Clinical trial NCT06565754: Effect of Adding Blood Flow Restriction to Strengthening Exercise in Patients With Patellofemoral Pain Syndrome
Official title: Effect of Adding Blood Flow Restriction to Strengthening Exercise in Patients With Patellofemoral Pain Syndrome
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: BFR
PFPS
Strengthening Exercises
Quadriceps Strength
Dynamic Balance
Joint Position Sense
Keywords: PFPS
Patellofemoral Pain Syndrome
Blood Flow Restriction Training
Strengthening Exercises
Dynamic Balance
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-08-22
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To study the effect of adding BFRT to strengthening exercises and compare it with strengthening exercises alone in improving, muscular strength, pain, function, joint position sense, and dynamic balance test (star excursion test). in patients with PFPS.

Detailed description: Background: Patellofemoral Pain Syndrome (PFPS) is a common condition characterized by anterior knee pain, particularly affecting individuals aged 15-30. It often involves lower limb muscle weakness, particularly in the quadriceps, which can exacerbate symptoms and affect functional performance. Blood Flow Restriction Training (BFRT) has shown promise in enhancing muscle strength and functional outcomes with reduced intensity compared to traditional high-intensity training.

Purpose: This study aims to compare the efficacy of combining BFRT with traditional strengthening exercises versus using strengthening exercises alone in improving muscular strength, pain, function, joint position sense, and dynamic balance in patients with PFPS.

Methods: A triple-blinded, randomized controlled trial was conducted at the Almenshawy General Hospital, Tanta, Egypt. Fifty patients with unilateral non-traumatic PFPS, aged 18-35, were randomly assigned to either a strengthening exercises group (SE Group) or a BFRT plus strengthening exercises group (BFRT Group). Both groups underwent a 6-week intervention with three sessions per week. Outcomes assessed included quadriceps and hip abductors strength, pain severity (Visual Analog Scale), functional status (Kujala Patellofemoral Score), joint position sense (measured by digital inclinometer), and dynamic balance (Star Excursion Balance Test).

Eligibility criteria: Inclusion Criteria:

* Patient referred from Orthopedic surgeon with diagnosis of patellofemoral pain syndrome PFPS.
* Both genders.
* BMI ranges from 18.5 to 29.9.
* Age ranges between 18 and 40 years experienced non-traumatic PFPS onset of anterior knee pain for greater than 2 weeks.
* Pain with any two activities, including running, jumping, squatting, kneeling, stair ascent/descent or prolonged sitting.

Exclusion Criteria:

* Coexisting pathology around the knee, including patellar subluxation or dislocation.
* Other sources of anterior knee pain (bursa, fat pad).
* Previous knee surgery.
* Suspicion of patellar tendinopathy, with strong consideration of pain localised to the patellar tendon.
* Any cardiovascular disease.
* Uncontrolled hypertension.
* Any lower limb trauma.
* Hip and ankle pathology.
* BMI more than 30%.
* Pregnancy.

Primary outcomes:
measure: quadriceps and hip abductors strength
timeFrame: 6 weeks
Secondary outcomes:
measure: pain severity using Visual Analog Scale (VAS)
timeFrame: 6 weeks
measure: functional status (Kujala Patellofemoral Score)
timeFrame: 6 weeks
measure: joint position sense (measured by digital inclinometer)
timeFrame: 6 weeks
measure: dynamic balance (Star Excursion Balance Test
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Cairo University
Study officials:
affiliation: Cairo University
name: enas F youssef, Professor
role: STUDY_CHAIR
affiliation: Cairo University
name: abdelgalil A shaaban, PhD
role: STUDY_DIRECTOR
affiliation: Tanta University
name: ahmed S helal, PhD
role: STUDY_DIRECTOR
affiliation: Pharos University in Alexandria
name: ahmed M khalil, PhD
role: STUDY_DIRECTOR
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