Effect of Adding Blood Flow Restriction to Strengthening Exercise in Patients With Patellofemoral Pain Syndrome (BFR)

August 20, 2024 updated by: Ahmed Mohamed Mahmoud Abdelaziz Khalil, Cairo University
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Egypt
      • Giza, Egypt, 12613
        • Cairo University
        • Contact:
        • Contact:
        • Principal Investigator:
          • ahmed S helal, PhD
        • Principal Investigator:
          • ahmed M khalil, PhD
        • Principal Investigator:
          • abdelgalil A shaaban, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: strengthening exercises group (SE Group)

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
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).
Experimental: BFRT plus strengthening exercises group (BFRT Group)

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: strengthening exercise
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).
Other: BFR

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
quadriceps and hip abductors strength
Time Frame: 6 weeks
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
6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
pain severity using Visual Analog Scale (VAS)
Time Frame: 6 weeks
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
6 weeks
functional status (Kujala Patellofemoral Score)
Time Frame: 6 weeks
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.
6 weeks
joint position sense (measured by digital inclinometer)
Time Frame: 6 weeks
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
6 weeks
dynamic balance (Star Excursion Balance Test
Time Frame: 6 weeks
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.
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Investigators

  • Study Chair: enas F youssef, Professor, Cairo University
  • Study Director: abdelgalil A shaaban, PhD, Cairo University
  • Study Director: ahmed S helal, PhD, Tanta University
  • Study Director: ahmed M khalil, PhD, Pharos University in Alexandria

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2024

Primary Completion (Estimated)

April 1, 2025

Study Completion (Estimated)

April 1, 2026

Study Registration Dates

First Submitted

July 26, 2024

First Submitted That Met QC Criteria

August 20, 2024

First Posted (Actual)

August 22, 2024

Study Record Updates

Last Update Posted (Actual)

August 22, 2024

Last Update Submitted That Met QC Criteria

August 20, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P.T.REC/012/005148 (Other Identifier: ethical committee faculty of physical therapy CU)

Plan for Individual participant data (IPD)

Study Data/Documents

  1. Study Protocol

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

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