Evaluating the Impact of Flossing Band Integration in Conventional Physiotherapy for Patellofemoral Pain Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Knee extensor muscle strength
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Conventional physiotherapy (Other)
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.
干预措施: Flossing band (Procedure)
结局指标
主要结局
Knee extensor muscle strength
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
- 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)
研究者
DAVID CRUZ DÍAZ
Principal Investigator
University of Jaén