An interventional study of BFR and strengthening exercise in BFR, PFPS and Strengthening Exercises, sponsored by Cairo University. Status unknown at 1 site in Egypt. Open to participants aged 18 Years to 35 Years. Per ClinicalTrials.gov, last updated 2024-08-22.
Sponsored by Cairo University · Not applicable, Interventional, and Treatment
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.
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).
299 studies on the registry are indexed under Patellofemoral Pain Syndrome; 74 are open to participants now.
This study's planned enrollment of 50 is close to the median of 46 across 246 interventional studies indexed under Patellofemoral Pain Syndrome.
Browse Patellofemoral Pain Syndrome studies →Cairo University is the lead sponsor of 4,909 studies on the registry; 1,445 are open to participants now.
Of its 37 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.
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Exclusion Criteria:
all patients will receive : 1. Isometric quadriceps exercise - 3 sets of 20 repetitions (5 s). 2. Straight leg raise (SLR) with 3 sets - 20 repetitions. 3. Short arc knee extension exercise - 3 sets of 20 repetitions. 4. Hip abduction from side lying - 3 sets of 20 repetitions.
Other: strengthening exercise
all patients will receive the below exercises using BFR cuff : 1. Isometric quadriceps exercise - 3 sets of 20 repetitions (5 s). 2. Straight leg raise (SLR) with 3 sets - 20 repetitions. 3. Short arc knee extension exercise - 3 sets of 20 repetitions. 4. Hip abduction from side lying - 3 sets of 20 repetitions.
Other: BFR · Other: strengthening exercise
Blood flow restriction training is an accessory to a variety of different exercise modes (e.g., resistance exercise, walking, cycling) has recently become a popular research topic. It involves the application of pressurized cuffs to the proximal portion of each lower extremity or upper extremity. It enhance blood pooling in the capillary beds of the limb muscles distal to the tourniquet or cuff. The 3rd Generation SmartCuffs® pump (SmartCuffs® 3.0 PRO) is Personalized Pressure feature which allows for a fast, hassle-free personalized pressure calculation. With the built-in pressure sensor and on-board computer, it is calculate arterial occlusion pressure and set the optimal pressure for patient's body. There is no need for an external doppler probe or hand pump. This unit will do everything for patient. Smart Cuffs 3rd generation is FDA Approved Listed Class 1 device. The automatized tourniquet (Smart Tools) contains a ring-shaped single- chamber
Quadriceps strengthening exercises are part of the treatment of PFPS, but the heavy resistance exercises may aggravate knee pain. Blood flow restriction training (BFRT) provides a low-load quadriceps strengthening method to treat PFPS (Giles et al., 2017).
quadriceps and hip abductors strength
Hand-Held Dynamometer (HHD). The Lafayette® HHD is a valid and reliable instrument of low cost and easy handling compared to the isokinetic dynamometer for assessment of muscle strength
Time frame: 6 weeks
pain severity using Visual Analog Scale (VAS)
The Visual Analog Scale is determined by measuring in millimeters from the left end of the line to the patient's mark. Participants will ask to determine the point at which pain represents the severity of pain maximum is 10 while lowest level of pain is zero
Time frame: 6 weeks
functional status (Kujala Patellofemoral Score)
The 13 items on the scale are used to assess subjective symptoms and functional restrictions. A score can have a minimum of 0 points or a maximum of 100 points.
Time frame: 6 weeks
joint position sense (measured by digital inclinometer)
Digital Inclinometer for joint position sense assessment. Device (Digital Protractor, 82201b-00, INSPEC, China) The inclinometer is a valid and reliable method to assess the knee proprioception through JPS in open kinetic chain
Time frame: 6 weeks
dynamic balance (Star Excursion Balance Test
Four strips of adhesive tape will need to be cut to a length of 6-8 feet each. Two pieces will be used to form a '+', with the other two being placed over top to form an 'x' so that a star shape is formed. It is important that all lines are separated from each other by a 45° angle. The goal of the Star Excursion Balance Test (SEBT) is to maintain single leg stance on one leg while reaching as far as possible with the contralateral leg.
Time frame: 6 weeks
Start is estimated for Sep 2024; primary completion for Apr 2025, 7 months later.
Of 154 non-industry interventional studies with no phase under Patellofemoral Pain Syndrome, half reached primary completion within 10 months of starting (the median), counting those still running; a quarter within 4 and three quarters within 20. This study's planned 7 months is below that.
Counting every sponsor, half of 158 studies reached it within 11 months; a quarter within 4 and three quarters within 21.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.
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