Clinical trial NCT06271811: Flossing Band Integration in Conventional Physiotherapy for Patellofemoral Pain Syndrome
Official title: Evaluating the Impact of Flossing Band Integration in Conventional Physiotherapy for Patellofemoral Pain Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anterior Knee Pain Syndrome
Patellofemoral Pain Syndrome
Keywords: Patellofemoral Pain Syndrome
physiotherapy
mind-body
flossing band
Lead sponsor: University of Jaén
Sponsor class: OTHER
Collaborators: name: University of Jaen
First posted: 2024-02-22
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Disability related to patellofemoral pain
timeFrame: From baseline to 8 weeks
measure: Knee extensor muscle strength
timeFrame: From baseline to 8 weeks
measure: Pain report
timeFrame: From baseline to 8 weeks
Secondary outcomes:
measure: Self-reported function
timeFrame: From baseline to 8 weeks
measure: Short Form-36 (SF-36)
timeFrame: From baseline to 8 weeks
measure: Berg Balance Scale (BBS)
timeFrame: From baseline to 8 weeks
measure: Pittsburgh Sleep Quality Index
timeFrame: From baseline to 8 weeks
measure: Brief Pain Questionnaire
timeFrame: From baseline to 8 weeks
measure: Perceived Stress Scale
timeFrame: From baseline to 8 weeks
Other outcomes:
Locations:
city: Jaen
country: Spain
facility: University of Jaen
Study officials:
affiliation: University of Jaén
name: David Cruz Diaz, PhD
role: STUDY_DIRECTOR
References: