Clinical Comparison of Patellofemoral Pain Syndrome Outcomes After Blood Flow Restriction Therapy
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 12
- 主要终点
- Lower Extremity Functional Scale: 4 Weeks
研究概览
简要总结
The purpose of this study is to determine if Blood Flow Restriction therapy improves patient related outcomes in those diagnosed with Patellofemoral Pain Syndrome compared to those in the sham comparator control group.
详细描述
Patellofemoral Pain Syndrome (PFPS), also known as Non-Specific Anterior Knee Pain (AKP), is a non-specific musculoskeletal condition characterized by loss of function and pain localized to the patella. PFPS affects up to 22% of the general population yearly, with females affected more so than males. Adolescents (28%, mixed gender) and elite athletes (up to 35% in knee dominant sports such as cycling) are also commonly affected, making this a relatively widespread condition. Additionally, PFPS has a generally unfavorable prognosis, with up to 40% of individuals failing conservative treatment after 1 year, and 57% reporting continued symptoms for 5 to 8-years following. Higher levels of baseline disability and longer duration of symptoms lead to an even poorer prognosis, making early recognition and novel treatments key. To complicate things further, the presence of negative psychosocial factors is commonly found in this population and may be a greater predictor of outcomes than physical ones.
Previously, biomechanical factors, such as maltracking of the patella and chondromalacia, have been called into question as potential causes of PFPS symptoms. However, both are now thought to be potential consequences of having PFPS. That being said, PFPS is generally accepted as a non-specific condition as there may be a number of different structures implicated as potential nociceptive drivers, and determining the exact tissue does not seem to be important to overall management strategies. This finding, in connection with the high prevalence of negative psychosocial factors, points less to a physiologically driven condition, and more towards a pain driven condition. While this theoretically makes diagnosing and treatment selection more ubiquitous, there does not seem to be a clear treatment strategy that works best for all patients. Despite a clear biomechanical cause, adjusting exercise selection or technique to include different loads and forces on the patella is still warranted based on patient presentation. For example, during open chain knee extension, the lowest loads are placed on the patella between 90- and 45-degree flexion, and open chain between 0 and 60 degrees. People with PFPS often benefit from adjusting the exercise selection, technique and load.
Recent research compared multiple different exercise strategies (combined core and hip work, knee work only, and open vs closed-chain), without any one program showing significant advantage over the others. A combination of these approaches may be best. One theme within PFPS exercise research that appears consistent is the high level of sensitivity and poor response to treatment where higher levels of pain are present. This is in contrast to tendon related pain, such as patellar tendinopathy, where working into moderate levels of pain seems to be helpful for outcomes.
The main mechanism driving improvements following exercise therapy for PFPS is not hypertrophy, but rather thought to be exercise induced hypoalgesia. This is a phenomenon where performing both acute bouts, as well as regular exercise (aerobic and resistance), reduces pain both in the short and long terms. Since exercise seems to reduce pain in both local and distant sites of the exercising area, it is thought to provide both local and systemic pain reducing effects. The magnitude and duration of the exercise seems to play an important role as well, with higher intensity and longer durations of exercising producing greater effects.
Since patients with PFPS are unable to achieve these desired parameters, alternative strategies need to be investigated. Two options may be blood flow restriction (BFR) therapy and low load training to failure, both of which may capture some of the hypoalgesic effects while minimizing AKP. BFR involves the application of an external device to reduce arterial blood flow to the exercising area, while largely occluding venous return from that same area. Exercise intensities generally range from 20-30% of the patients' 1 repetition maximum (1RM) weight, with relatively high repetitions (sometimes to failure); this is opposed to traditional resistance training at 70%+ of 1RM. BFR training has been demonstrated to amplify the effects of exercise induced hypoalgesia (in addition to a host of other physiological benefits) through unconfirmed mechanisms. Leading theories suggest that the lack of available oxygen to the exercising area may lead to: the activation of the endogenous opioid and cannabinoid systems; systemic changes to the cardiovascular system; or increased number of metabolites such as hydrogen ions and lactic acid, which may also be contributing factors.
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
- None
入排标准
- 年龄范围
- 15 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of patellofemoral pain syndrome (PFPS) or non-specific anterior knee pain (NSAKP) and plan to attend Gaylord Specialty Healthcare Physical Therapy
排除标准
- •Member of a defined vulnerable population, women who are or suspected to be pregnant, prisoners, children under 15, or other protected populations
- •Body mass of the leg preventing the cuff from fitting properly
- •Radiographic evidence of osteoarthritis (≥ Kellgren-Lawrence Grade 2)
- •History of intra-articular injection into either knee within 3 -months
- •Uncontrolled or untreated inflammatory disorder
- •Acute inflammatory disorder
- •Uncontrolled Diabetes and/or peripheral neuropathy, impaired circulation
- •Uncontrolled cardiac conditions including uncontrolled hypertension
- •Areas of thrombophlebitis, thrombosis
- •Distal wounds or pain below the knee >4/10
- •History of or current rhabdomyolysis
- •Prolonged immobilization (>3 months)
- •Sickle cell anemia
- •Lymphadenectomy
- •Varicose veins, or a history of personal or immediate family history (parental or sibling) of deep vein thrombosis
- •Current infection at or below the level of cuff placement
- •Malignancies in or below the area to be treated
- •Other conditions/medications that would interfere with subject safety or data collection in the opinion of the PI
- •Subjects with an increased risk of non-response as determined by the therapist
- •Once entered in the study, a diagnosis change that affects participation
结局指标
主要结局
Lower Extremity Functional Scale: 4 Weeks
时间窗: This assessment will be collected 4-weeks into treatment.
The LEFS is a 20 question survey that is a valid PROM used for the measurement of lower extremity function based on the patients' initial function, ongoing progress, and long-term outcome
Numeric Pain Rating Scale: Enrollment
时间窗: This assessment will be collected upon enrollment in the study.
The Numeric Pain Rating Scale is one question pain intensity scale that assesses the current, best, and worst pain level in the last 24 hours
Numeric Pain Rating Scale: 1 Week
时间窗: This assessment will be collected 1-week into treatment
The Numeric Pain Rating Scale is one question pain intensity scale that assesses the current, best, and worst pain level in the last 24 hours
Numeric Pain Rating Scale: 4 Weeks
时间窗: This assessment will be collected 4-weeks into treatment.
The Numeric Pain Rating Scale is one question pain intensity scale that assesses the current, best, and worst pain level in the last 24 hours
Lower Extremity Functional Scale: 9 Weeks/Discharge
时间窗: This assessment will be collected 9-weeks into treatment or at discharge, whatever comes first.
The LEFS is a 20 question survey that is a valid PROM used for the measurement of lower extremity function based on the patients' initial function, ongoing progress, and long-term outcome
Knee Injury and Osteoarthritis Outcome Score for Patellofemoral Pain: 1 Week
时间窗: This assessment will be collected1-week into treatment.
The KOOS-PF is an 11 question survey that is used to assess five outcomes; they include knee related Quality of Life, activities of daily living, sport and recreation function, activities, pain and symptoms
Knee Injury and Osteoarthritis Outcome Score for Patellofemoral Pain: 4 Weeks
时间窗: This assessment will be collected 4-weeks into treatment.
The KOOS-PF is an 11 question survey that is used to assess five outcomes; they include knee related Quality of Life, activities of daily living, sport and recreation function, activities, pain and symptoms
Knee Injury and Osteoarthritis Outcome Score for Patellofemoral Pain: 9 Weeks/Discharge
时间窗: This assessment will be collected 9-weeks into treatment or at discharge, whatever comes first.
The KOOS-PF is an 11 question survey that is used to assess five outcomes; they include knee related Quality of Life, activities of daily living, sport and recreation function, activities, pain and symptoms
Numeric Pain Rating Scale: 9 Weeks/Discharge
时间窗: This assessment will be collected 9-weeks into treatment or at discharge, whatever comes first.
The Numeric Pain Rating Scale is one question pain intensity scale that assesses the current, best, and worst pain level in the last 24 hours
Numeric Pain Rating Scale: 6 Months
时间窗: This assessment will be collected 6 months post start date.
The Numeric Pain Rating Scale is one question pain intensity scale that assesses the current, best, and worst pain level in the last 24 hours
Lower Extremity Functional Scale: 6 Months
时间窗: This assessment will be collected 6 months post start date.
The LEFS is a 20 question survey that is a valid PROM used for the measurement of lower extremity function based on the patients' initial function, ongoing progress, and long-term outcome
Tenger Activity Scale: 6 Months
时间窗: This assessment will be collected 6 months post start date.
The Tenger Activity Scale aims to provide a standardized method in determining the level of activity prior to injury and level of activity post injury that can be documented on a numerical scale.
Tenger Activity Scale: 12 Months
时间窗: This assessment will be collected 12 months post start date.
The Tenger Activity Scale aims to provide a standardized method in determining the level of activity prior to injury and level of activity post injury that can be documented on a numerical scale.
Fear Avoidance Beliefs Questionnaire: 1 Week
时间窗: This assessment will be collected 1-week into treatment.
The Fear Avoidance Belief Questionnaire is a 16 question likert scale questionnaire aimed at assessing how everyday activities assess the patient's current level of pain
Fear Avoidance Beliefs Questionnaire: 4 Weeks
时间窗: This assessment will be collected 4-weeks into treatment.
The Fear Avoidance Belief Questionnaire is a 16 question likert scale questionnaire aimed at assessing how everyday activities assess the patient's current level of pain
Numeric Pain Rating Scale: 12 Months
时间窗: This assessment will be collected 12 months post start date.
The Numeric Pain Rating Scale is one question pain intensity scale that assesses the current, best, and worst pain level in the last 24 hours
Lower Extremity Functional Scale: 1 Week
时间窗: This assessment will be collected 1-week into treatment.
The LEFS is a 20 question survey that is a valid PROM used for the measurement of lower extremity function based on the patients' initial function, ongoing progress, and long-term outcome
Knee Injury and Osteoarthritis Outcome Score for Patellofemoral Pain: Enrollment
时间窗: This assessment will be collected upon enrollment in the study.
The KOOS-PF is an 11 question survey that is used to assess five outcomes; they include knee related Quality of Life, activities of daily living, sport and recreation function, activities, pain and symptoms
Knee Injury and Osteoarthritis Outcome Score for Patellofemoral Pain: 6 Months
时间窗: This assessment will be collected 6 months post start date.
The KOOS-PF is an 11 question survey that is used to assess five outcomes; they include knee related Quality of Life, activities of daily living, sport and recreation function, activities, pain and symptoms
Single Assessment Numerical Evaluation: 4 Weeks
时间窗: This assessment will be collected 4-weeks into treatment.
The SANE is a two item questionnaire used globally to assess function
Single Assessment Numerical Evaluation: 6 Months
时间窗: This assessment will be collected 6 months post start date.
The SANE is a two item questionnaire used globally to assess function
Fear Avoidance Beliefs Questionnaire: 9 Weeks/Discharge
时间窗: This assessment will be collected 9-weeks into treatment or at discharge, whatever comes first.
The Fear Avoidance Belief Questionnaire is a 16 question likert scale questionnaire aimed at assessing how everyday activities assess the patient's current level of pain
Fear Avoidance Beliefs Questionnaire: 6 Months
时间窗: This assessment will be collected 6 months post start date.
The Fear Avoidance Belief Questionnaire is a 16 question likert scale questionnaire aimed at assessing how everyday activities assess the patient's current level of pain
Lower Extremity Functional Scale: Enrollment
时间窗: This assessment will be collected upon enrollment in the study.
The LEFS is a 20 question survey that is a valid PROM used for the measurement of lower extremity function based on the patients' initial function, ongoing progress, and long-term outcome
Lower Extremity Functional Scale: 12 Months
时间窗: This assessment will be collected 12 months post start date.
The LEFS is a 20 question survey that is a valid PROM used for the measurement of lower extremity function based on the patients' initial function, ongoing progress, and long-term outcome
Knee Injury and Osteoarthritis Outcome Score for Patellofemoral Pain: 12 Months
时间窗: This assessment will be collected 12 months post start date.
The KOOS-PF is an 11 question survey that is used to assess five outcomes; they include knee related Quality of Life, activities of daily living, sport and recreation function, activities, pain and symptoms
Single Assessment Numerical Evaluation: Enrollment
时间窗: This assessment will be collected upon enrollment in the study.
The SANE is a two item questionnaire used globally to assess function
Single Assessment Numerical Evaluation: 9 Weeks/Discharge
时间窗: This assessment will be collected 9-weeks into treatment or at discharge, whatever comes first.
The SANE is a two item questionnaire used globally to assess function
Fear Avoidance Beliefs Questionnaire: Enrollment
时间窗: This assessment will be collected upon enrollment in the study.
The Fear Avoidance Belief Questionnaire is a 16 question likert scale questionnaire aimed at assessing how everyday activities assess the patient's current level of pain
Fear Avoidance Beliefs Questionnaire: 12 Months
时间窗: This assessment will be collected 12 months post start date.
The Fear Avoidance Belief Questionnaire is a 16 question likert scale questionnaire aimed at assessing how everyday activities assess the patient's current level of pain
Single Assessment Numerical Evaluation: 1 Week
时间窗: This assessment will be collected 1-week into treatment.
The SANE is a two item questionnaire used globally to assess function
Single Assessment Numerical Evaluation: 12 Months
时间窗: This assessment will be collected 12 months post start date.
The SANE is a two item questionnaire used globally to assess function
Tenger Activity Scale: Enrollment
时间窗: This assessment will be collected upon enrollment.
The Tenger Activity Scale aims to provide a standardized method in determining the level of activity prior to injury and level of activity post injury that can be documented on a numerical scale.
次要结局
- Quadricep Isometric Strength: 9 Weeks/Discharge(This assessment will be collected 9-weeks into treatment or at discharge, whatever comes first.)
- Quadricep Isometric Strength: 4 Weeks(This assessment will be collected 4-weeks into treatment.)
- Quadricep Isometric Strength: Enrollment(This assessment will be collected upon enrollment in the study.)
- Quadricep Isometric Strength: 1 Week(This assessment will be collected 1-week into treatment.)