Comparison Between Foot Segment Mulligan Mobilization and Ilium Mulligan Mobilization in Treatment Patellofemoral Pain Patients With Flatfeet: a Randomized Controlled Comparative Study (PFP)
Targeting the Lower-Limb Kinetic Chain in Patellofemoral Pain: A Randomized Comparison of Foot and Ilium Mulligan Mobilization Combined With Hip-Knee Focused Exercises
研究概览
地位
详细说明
Patellofemoral pain is a common musculoskeletal condition characterized by pain around or behind the patella that is aggravated by activities such as squatting, stair negotiation, running, and prolonged sitting. Although local knee impairments may contribute to symptoms, factors throughout the lower-limb kinetic chain may also influence patellofemoral mechanics and clinical presentation.
Foot pronation may alter lower-limb biomechanics during weight-bearing activities and may contribute to changes in tibial and femoral movement. Proximal factors, including pelvic alignment and dynamic knee valgus, may also influence lower-limb loading and patellofemoral joint mechanics. Exercise therapy targeting the hip and knee is commonly used for the management of patellofemoral pain; however, it may not fully address kinetic-chain impairments in patients presenting with concomitant foot pronation.
This study will evaluate whether adding Mulligan mobilization directed toward either the distal foot segment or the proximal ilium/pelvic segment provides additional clinical and biomechanical benefits when combined with a standardized hip- and knee-focused exercise program.
Participants with patellofemoral pain and clinically relevant foot pronation will be screened according to predefined eligibility criteria and randomly allocated to one of three parallel groups:
Foot Mulligan Mobilization Group: Participants will receive standardized hip- knee focused therapeutic exercises combined with Mulligan mobilization directed toward the foot segment.
Ilium Mulligan Mobilization Group: Participants will receive the same standardized hip- knee focused therapeutic exercises combined with Mulligan mobilization directed toward the ilium/pelvic segment.
Control Group: Participants will receive the standardized hip- knee focused therapeutic exercise program alone.
The intervention period will last 4 weeks. Outcome measures will be assessed at baseline and immediately after completion of the intervention.
The primary outcomes will be pain intensity, assessed using the Visual Analogue Scale (VAS), and functional status, assessed using the Anterior Knee Pain Scale (AKPS). Secondary outcomes will include hip and knee muscle strength assessed using a handheld dynamometer, dynamic knee valgus assessed using photogrammetric analysis and Kinovea motion-analysis software, pelvic tilt angle assessed using a PALM/pelvic inclinometer, and foot posture assessed using the Foot Posture Index (FPI).
The study will primarily examine changes over time and differences among the three treatment groups, with particular attention to the group-by-time interaction. Appropriate statistical analyses will be performed based on the distribution and characteristics of the collected data, with statistical significance set at p < 0.05.
The study aims to determine whether targeting the distal or proximal segment of the lower-limb kinetic chain provides greater additional benefit when combined with hip-knee focused exercises in patients with patellofemoral pain and foot pronation.
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名:Labib M Ghali, PhD
- 电话号码:002 01201991948
- 邮箱:labibmousa7@cu.edu.eg
研究联系人备份
- 姓名:Samah H Nagib, PhD
- 电话号码:00962 776671425
- 邮箱:s.nagib@zuj.edu.jo
学习地点
-
-
-
Amman、约旦、11733
- Al-Zaytoonah University of Jordan
-
接触:
- Samah H Nagib, PhD
- 电话号码:00962 776671425
- 邮箱:s.nagib@zuj.ed.jo
-
-
参与标准
资格标准
适合学习的年龄
- 成人
接受健康志愿者
描述
Inclusion Criteria:
- Age of the subjects between 18-35 years
- BMI was from 18.5 to ≤ 29.5 Kg/m² .
- Anterior or retro patellar knee pain for at least 6 weeks duration.
- Foot posture index score from +6 to + 12.
- Sagittal plane innominate tilt angle more than 8 degrees.
- Pain elicited at least by two of the following four screening tests; (i) isometric muscle contraction with slight bent knee,(ii) palpation of the patella, (iii) patellar compression against the femoral bone (iv) active resisted knee extension.
- Pain provoked by at least two of the following activities: running, walking, hopping, squatting, stair negotiation, kneeling, or prolonged sitting
Exclusion Criteria:
- Meniscal or other intra-articular pathologic conditions; cruciate or collateral ligament involvement.
- A history of traumatic patellar subluxation or dislocation..
- Previous surgery in the knee, ankle and hip joints.
- Knee, ankle and hip joints osteoarthritis.
- Taking non-steroidal anti-inflammatory drugs or corticosteroids within 24 hours before the test.
- History of brain injury or vestibular disorder within the last 6 months.
- Pregnant female.
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的:Group A: Foot segment Milligan mobilization group
mobilization with movement for talonavicular and talocrural joint + Hip-knee focused exercises
|
Mobilization with movement of the foot segment First, a dorsal glide of the talonavicular joint will be combined with plantarflexion and inversion of the foot. Second, a posterior glide of the talocrural joint will be applied in combination with the corresponding active ankle dorsiflexion. Both mobilization techniques will be applied for 10 repetitions/ 3 sets
其他名称:
Stretching exercises will include hamstring dynamic stretching from a supine position, soleus muscle stretching from a step-down position and standing the iliotibial band stretches first with arms at the side and then with arms extending overhead. Stretching exercises were performed 3 times, with a 30-s hold and a 1- in rest between each set and each muscle. The hip exercises will consist of bridging with an isometric hip abduction exercise from a supine position for hip extensors, side-lying hip abduction and clamshell at 30° hip flexion for hip external rotators. The knee exercises will involve mini wall squatting from 0-45° with a band around the distal thigh to engage hip abductors and external rotators, terminal knee extension exercise from a standing position and seated knee extension exercise from 90° to 45° knee flexion.
其他名称:
|
|
实验性的:Group B: Ilium Milligan mobilization group
mobilization with movement of ilium + Hip-knee focused exercises
|
Stretching exercises will include hamstring dynamic stretching from a supine position, soleus muscle stretching from a step-down position and standing the iliotibial band stretches first with arms at the side and then with arms extending overhead. Stretching exercises were performed 3 times, with a 30-s hold and a 1- in rest between each set and each muscle. The hip exercises will consist of bridging with an isometric hip abduction exercise from a supine position for hip extensors, side-lying hip abduction and clamshell at 30° hip flexion for hip external rotators. The knee exercises will involve mini wall squatting from 0-45° with a band around the distal thigh to engage hip abductors and external rotators, terminal knee extension exercise from a standing position and seated knee extension exercise from 90° to 45° knee flexion.
其他名称:
the patients will be in prone position with their hands at shoulder level, and the therapist will stand on the opposite side of the mobilized ilium.
The therapist will stabilize the sacrum with the medial aspect of one hand, place the fingers of the other hand under the anterior superior iliac spine, and then will pull the ilium in posterior translation and rotation in relation to the sacrum.
Next, the patient will be asked to perform 10 pain-free press-ups by extending the elbows.
The mobilization included 3 sets with 10 repetitions for each set and a 30-s rest in between.
|
|
有源比较器:Group C: Control group
Hip-knee focused exercises only
|
Stretching exercises will include hamstring dynamic stretching from a supine position, soleus muscle stretching from a step-down position and standing the iliotibial band stretches first with arms at the side and then with arms extending overhead. Stretching exercises were performed 3 times, with a 30-s hold and a 1- in rest between each set and each muscle. The hip exercises will consist of bridging with an isometric hip abduction exercise from a supine position for hip extensors, side-lying hip abduction and clamshell at 30° hip flexion for hip external rotators. The knee exercises will involve mini wall squatting from 0-45° with a band around the distal thigh to engage hip abductors and external rotators, terminal knee extension exercise from a standing position and seated knee extension exercise from 90° to 45° knee flexion.
其他名称:
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Function measured by Anterior Knee Pain Scale
大体时间:baseline and after 4 weeks
|
Anterior Knee Pain Scale (AKPS) It is a self-administered, weighted questionnaire that examines 13 different items including pain and functionality and a maximum score of 100 points, with higher scores indicating better lower extremity function.
It documents response to six activities associated specifically with AKPS (walking, running, jumping, climbing stairs, squatting and sitting for prolonged period with knee bent).
This scale has demonstrated high test-retest reliability and is considered a good and valid detector for significant changes after treatment of patients with PFPS.
|
baseline and after 4 weeks
|
|
Pain measured by Numeric pain rating scale (NPRS)
大体时间:baseline and after 4 weeks
|
Numeric pain rating scale (NPRS) The numeric pain rating scale ranges from 0 to 10 points, where 0 represents no pain and 10 represents the worst possible suffering.
Its ICC which measures the reliability of test-retests, has been 0.76, indicating that it is a reliable measure of pain intensity.
|
baseline and after 4 weeks
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Muscle strength by hand-held dynamometer
大体时间:baseline and after 4 weeks
|
This device is valid and reliable in assessment of muscle strength during the dynamic movement and also during the isometric contraction of the muscles with intra-rater correlation coefficient (ICC ≥0.75). It used to assess the isometric muscle strength of hip and knee joint in patient with PFPS by using a calibrated Nicholas hand-held dynamometer (Lafayette Instrument Company, Lafayette, IN, USA) which characterized by good to excellent interrater and intra-rater reliability |
baseline and after 4 weeks
|
|
Pelvic tilt angle by Palpation Meter device (PALM)
大体时间:baseline and after 4 weeks
|
Palpation meter (PALM) is a pelvic leveling tool that blends inclinometer and caliper functions, it's made by performance Attainment Associates (Performance Attainment Associates, 3600 LaBore, Suite 6, Saint Paul, MN 55110 - 4144 USA).
It's developed to measure pelvic torsion, pelvic tilting and leg length discrepancy (LLD).
The body of the PALM contains a bubble level in a semi-circular arc with one-degree graduations that range from zero degree to thirty degrees on either side of the midline.
The caliper arms are placed in bony landmarks and the degree of deviation from horizontal is read from the inclinometer.
Interclass correlation coefficient suggests that intratester reliability was high for frontal plane measure (0.84) and sagittal plane measures (0.98) and intertester reliability was high for sagittal plane measures (0.89) but moderate for frontal plane measures (0.65).
|
baseline and after 4 weeks
|
|
foot pronation by Foot Posture Index (FPI)
大体时间:baseline and after 4 weeks
|
It is a clinical tool that measures foot posture in multiple planes and anatomical segments. Its correlation coefficient showed excellent intra-rater reliability (ICC = 0.89-0.96) which indicates a very good FPI-6 reliability in the foot assessment. The FPI-6 is a valid cheap non-invasive instrument which in a fast and simple way allows one to conduct a comprehensive evaluation of many parameters of the foot's construction without the need to apply complex and time-consuming measurement methods. Foot posture index determined either the foot was pronated or not based on the scores of its six items (talar head palpation curves above and below the lateral malleoli, calcaneal angle, talonavicular bulge, medial longitudinal arch, and forefoot to rearfoot alignment). Each of the six items of FPI-6 was evaluated on a scale from -2 to +2. The neutral position of the foot is classified as 0, a positive score is foot pronation and negative score is foot supination |
baseline and after 4 weeks
|
合作者和调查者
调查人员
- 首席研究员:Labib M Ghali, PhD、Cairo University
- 学习椅:Samah H Nagib, PhD、Al-Zaytoonah University of Jordan
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.