Flossing Band Integration in Conventional Physiotherapy for Patellofemoral Pain Syndrome

NCT ID: NCT06271811

Last Updated: 2024-02-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-09
• Study Completion Date: 2023-11-20

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.

Conditions

Anterior Knee Pain Syndrome; Patellofemoral Pain Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Control group

The intervention protocol is centered on neuromuscular training, targeting the strengthening of key muscle groups including the quadriceps, hamstrings, and hip abductors, which are vital for knee stabilization. This approach is supported by previous research, emphasizing the importance of these muscle groups in knee joint health. Complementing this, proprioceptive exercises, such as single-leg balances and controlled knee bends, were incorporated to enhance joint position sense, aligning with the guidelines set forth by Powers et al., 2010.

The intensity of these exercises is progressively increased, tailored to each patient's tolerance and improvement. The protocol stipulates two sessions per week over eight weeks.

Group Type: ACTIVE_COMPARATOR

Conventional physiotherapy

Intervention Type: OTHER

The intervention protocol is centered on neuromuscular training, targeting the strengthening of key muscle groups including the quadriceps, hamstrings, and hip abductors, which are vital for knee stabilization. This approach is supported by previous research, emphasizing the importance of these muscle groups in knee joint health. Complementing this, proprioceptive exercises, such as single-leg balances and controlled knee bends, were incorporated to enhance joint position sense, aligning with the guidelines set forth by Powers et al., 2010.

The intensity of these exercises is progressively increased, tailored to each patient's tolerance and improvement. The protocol stipulates two sessions per week over eight weeks.

Intervention group

The application of flossing to the knee commences with a preliminary evaluation of the joint range of motion and pain perception. The band is wrapped around the knee, starting with an approximate tension of 50% for the first wrap and escalating to a tension of 60-80% in subsequent wraps. It is essential to overlap the band with each wrap, moving from a distal to the proximal direction (bottom to top), which aids in enhancing drainage. Continuous monitoring of the patient is critical to ensure that excessive pressure is not being applied. This can be achieved by palpating the pulse on the dorsum of the foot or inner ankle, and observing if the skin regains its normal color after pressing the area with fingers. Should the patient experience strong tingling or pain, the bandage must be immediately removed. The duration of the band's application varies between 2 to 5 minutes, depending on patient tolerance, a methodology informed by existing research.

Group Type: EXPERIMENTAL

Flossing band

Intervention Type: PROCEDURE

The application of flossing to the knee commences with a preliminary evaluation of the joint range of motion and pain perception. The band is wrapped around the knee, starting with an approximate tension of 50% for the first wrap and escalating to a tension of 60-80% in subsequent wraps. It\'s essential to overlap the band with each wrap, moving from a distal to the proximal direction (bottom to top), which aids in enhancing drainage. Continuous monitoring of the patient is critical to ensure that excessive pressure is not being applied. This can be achieved by palpating the pulse on the dorsum of the foot or inner ankle, and observing if the skin regains its normal color after pressing the area with fingers. Should the patient experience strong tingling or pain, the bandage must be immediately removed. The duration of the band's application varies between 2 to 5 minutes, depending on patient tolerance, a methodology informed by existing research.

Interventions

Flossing band

The application of flossing to the knee commences with a preliminary evaluation of the joint range of motion and pain perception. The band is wrapped around the knee, starting with an approximate tension of 50% for the first wrap and escalating to a tension of 60-80% in subsequent wraps. It\'s essential to overlap the band with each wrap, moving from a distal to the proximal direction (bottom to top), which aids in enhancing drainage. Continuous monitoring of the patient is critical to ensure that excessive pressure is not being applied. This can be achieved by palpating the pulse on the dorsum of the foot or inner ankle, and observing if the skin regains its normal color after pressing the area with fingers. Should the patient experience strong tingling or pain, the bandage must be immediately removed. The duration of the band's application varies between 2 to 5 minutes, depending on patient tolerance, a methodology informed by existing research.

Intervention Type: PROCEDURE

Conventional physiotherapy

The intervention protocol is centered on neuromuscular training, targeting the strengthening of key muscle groups including the quadriceps, hamstrings, and hip abductors, which are vital for knee stabilization. This approach is supported by previous research, emphasizing the importance of these muscle groups in knee joint health. Complementing this, proprioceptive exercises, such as single-leg balances and controlled knee bends, were incorporated to enhance joint position sense, aligning with the guidelines set forth by Powers et al., 2010.

The intensity of these exercises is progressively increased, tailored to each patient's tolerance and improvement. The protocol stipulates two sessions per week over eight weeks.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Jaen

UNKNOWN

Sponsor Role: collaborator

University of Jaén

OTHER

Sponsor Role: lead

Responsible Party

DAVID CRUZ DÍAZ

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

David Cruz Diaz, PhD

Role: STUDY_DIRECTOR

University of Jaén

Locations

University of Jaen

Jaén, , Spain

Countries

Spain

Other Identifiers

UJAPFPS

Identifier Type: -

Identifier Source: org_study_id