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Clinical Trials/NCT06271811
NCT06271811
Completed
Not Applicable

Evaluating the Impact of Flossing Band Integration in Conventional Physiotherapy for Patellofemoral Pain Syndrome

University of Jaén1 site in 1 country50 target enrollmentJanuary 9, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Anterior Knee Pain Syndrome
Sponsor
University of Jaén
Enrollment
50
Locations
1
Primary Endpoint
Knee extensor muscle strength
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

The goal of this clinical trial is to assess the efficacy of adding flossing band therapy to conventional physiotherapy in patients diagnosed with Patellofemoral Pain Syndrome (PFPS). The main questions it aims to answer are:

  • Does combining flossing band therapy with conventional physiotherapy lead to greater improvements in pain, strength, and function compared to conventional physiotherapy alone?
  • What are the effects of flossing band therapy on knee functionality and muscle strength in PFPS patients? Participants will be randomly assigned to either the Standard Physiotherapy group or the Flossing Band and Physiotherapy group. In addition to conventional physiotherapy, participants in the Flossing Band group will undergo sessions where a flossing band is applied around the knee joint to provide moderate compression. Researchers will compare the two groups to determine if the addition of flossing band therapy enhances treatment outcomes for PFPS.

Detailed Description

The goal of this clinical trial is to assess the efficacy of integrating flossing band therapy into conventional physiotherapy for individuals diagnosed with Patellofemoral Pain Syndrome (PFPS). A double-blinded, randomized controlled trial was conducted to evaluate the influence of adding flossing band application to conventional physiotherapy based on 8 weeks of resistance training in patients with PFPS. The study was approved by the research ethics committee of the University of Jaén and conducted in accordance with the Code of Ethics of the World Medical Association for human studies (Declaration of Helsinki). A sample of 50 participants diagnosed with PFPS were randomly allocated into two distinct groups: the Standard Physiotherapy Group (SPG) and the Flossing Band and Physiotherapy Group (FBPG). Eligibility criteria included a clinical diagnosis of PFPS, retro patellar pain for at least three months, and no recent medical treatment or lower extremity surgery within the last six months. Participants underwent assessments at baseline and after 8 weeks of rehabilitation protocols, including standardized measures of pain intensity, knee functionality, and overall mobility. The intervention protocols involved either conventional physiotherapy focused on neuromuscular training or a combined treatment regimen of conventional physiotherapy along with additional flossing band therapy targeting the knee region. Researchers applied rigorous blinding protocols to ensure impartial evaluations and minimize bias. Outcome measures included the Kujala Anterior Knee Pain Scale (AKPS), handheld dynamometry for knee extensor muscle strength, a visual analog scale (VAS) for pain assessment, and the Lower Extremity Functional Scale (LEFS) for self-reported function, isokinetic variables, including peak torque, total work, and average power, were assessed using the Biodex System 4 dynamometer and emotional and psychological variables. The study aimed to determine if the addition of flossing band therapy enhances treatment outcomes for PFPS compared to conventional physiotherapy alone.

Registry
clinicaltrials.gov
Start Date
January 9, 2023
End Date
November 20, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
University of Jaén
Responsible Party
Principal Investigator
Principal Investigator

DAVID CRUZ DÍAZ

Principal Investigator

University of Jaén

Eligibility Criteria

Inclusion Criteria

  • A clinical diagnosis of Patellofemoral Pain Syndrome or patellofemoral misalignment, as confirmed by clinical signs and/or imaging studies (e.g., knee CT scans).
  • An age range of 18 to 50 years, to include a broad spectrum of the population affected by PFPS.
  • Experience retro patellar pain for at least three months, including pain at rest or during activities such as ascending or descending stairs, jumping, running, squatting, kneeling, or prolonged sitting.
  • Pain or apprehension upon mobilization of the patella, and/or crepitus accompanied by pain during activities like squats.
  • No history of medical treatment, physiotherapy specifically targeting PFPS, or lower extremity surgery within the last six months.

Exclusion Criteria

  • A history of significant lower extremity, pelvic, or spinal surgery/fracture, or traumatic lesions of ligaments or meniscus within the past six months.
  • Presence of other orthopedic conditions (e.g., ligament rupture, meniscal tears), neurological disorders (e.g., multiple sclerosis, paralysis), rheumatological diseases (e.g., rheumatoid arthritis, ankylosing spondylitis), or congenital conditions leading to osteoarthrosis.
  • Current pregnancy.
  • A history of connective tissue disease, patellofemoral dislocation or subluxation, or osteoarthrosis of the knees.
  • Use of sedatives or muscle relaxants that may alter muscle tone.
  • Other forms of anterior knee pain (e.g., Osgood-Schlatter disease, tendon pain, bursitis).
  • A history of referred pain from the lumbar spine.

Outcomes

Primary Outcomes

Knee extensor muscle strength

Time Frame: From baseline to 8 weeks

In addition to isokinetic variables assessed with the Biodex System 4 dynamometer, manual handheld dynamometry was employed to measure knee extensor muscle strength, providing a comprehensive evaluation of muscle function in individuals with Patellofemoral Pain Syndrome.

Disability related to patellofemoral pain

Time Frame: From baseline to 8 weeks

The Kujala Anterior Knee Pain Scale was employed to assess this variable. is a well-established tool used to evaluate symptoms and functional limitations in individuals with patellofemoral pain syndrome. This self-reported questionnaire comprises 13 items, each rated to provide a total score ranging from 0 to 100, where higher scores denote better knee function and fewer symptoms. While specific cut-off points are not universally defined, scores closer to 100 generally indicate minimal patellofemoral issues.

Pain report

Time Frame: From baseline to 8 weeks

Pain was measured using a visual analogue scale (VAS). The VAS consists of a 10-cm line, with the left extremity representing (the absence of pain) and the right extremity indicating (the worse pain devisable). Participants were asked to indicate on the scale their current level of pain being higher values related to more intense pain.

Secondary Outcomes

  • Pittsburgh Sleep Quality Index(From baseline to 8 weeks)
  • Berg Balance Scale (BBS)(From baseline to 8 weeks)
  • Perceived Stress Scale(From baseline to 8 weeks)
  • Short Form-36 (SF-36)(From baseline to 8 weeks)
  • Self-reported function(From baseline to 8 weeks)
  • Brief Pain Questionnaire(From baseline to 8 weeks)

Study Sites (1)

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