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临床试验/NCT07382037
NCT07382037
尚未招募
不适用

Efficacy of Whole-Body Vibration in Patients With Patellofemoral Pain Syndrome: A Prospective, Randomized, Double-Blind, Placebo-Controlled Clinical Trial

Pamukkale University1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2026年1月15日最近更新:

概览

阶段
不适用
状态
尚未招募
入组人数
40
试验地点
1
主要终点
VAS

概览

简要总结

Patellofemoral Pain Syndrome (PFPS), or anterior knee pain, is one of the most common disorders affecting the lower extremities.

Currently, there is no established "gold standard" treatment for PFPS. However, various interventions-including strengthening of the hip and knee muscles (e.g., hip abductors, external rotators, and knee extensors), taping, bracing, foot orthoses, manual therapy, acupuncture, blood flow restriction training, and conventional physical agents (e.g., ultrasound, cryotherapy, neuromuscular electrical stimulation, laser therapy, electromyographic biofeedback, etc.)-have been reported to provide meaningful clinical benefits. Strengthening of the hip and knee muscles alone has been shown to improve both pain and function in the short, medium, and long term. In recent high-quality studies, hip and knee muscle strengthening has been recognized as an effective "classical" treatment approach for PFPS. Regarding the mechanism of pain relief, previous research suggests that strengthening these muscles may alleviate pain by stabilizing patellar motion and/or reducing pressure on the patellofemoral joint.

Similar to traditional resistance training, whole-body vibration (WBV) training is an alternative method for muscle strengthening. WBV platforms can generate vertical vibrations that stimulate tonic vibration reflexes through muscle spindles, thereby activating homonymous alpha motor neurons and inducing reflex muscle contractions. As a result, increased motor unit recruitment enhances the excitability of muscle spindles, leading to improved muscle strength. Additionally, WBV training can improve muscle balance, strength, and function. Therefore, combining WBV with hip and knee strengthening exercises may represent a more effective treatment strategy for PFPS. The aim of this study is to evaluate whether the combination of WBV and hip-knee muscle strengthening is more effective in reducing pain and improving function than hip-knee strengthening alone.

详细描述

Patellofemoral Pain Syndrome (PFPS), or anterior knee pain, is one of the most common disorders affecting the lower extremities.

Currently, there is no established "gold standard" treatment for PFPS. However, various interventions-including strengthening of the hip and knee muscles (e.g., hip abductors, external rotators, and knee extensors), taping, bracing, foot orthoses, manual therapy, acupuncture, blood flow restriction training, and conventional physical agents (e.g., ultrasound, cryotherapy, neuromuscular electrical stimulation, laser therapy, electromyographic biofeedback, etc.)-have been reported to provide meaningful clinical benefits. Strengthening of the hip and knee muscles alone has been shown to improve both pain and function in the short, medium, and long term. In recent high-quality studies, hip and knee muscle strengthening has been recognized as an effective "classical" treatment approach for PFPS. Regarding the mechanism of pain relief, previous research suggests that strengthening these muscles may alleviate pain by stabilizing patellar motion and/or reducing pressure on the patellofemoral joint.

Similar to traditional resistance training, whole-body vibration (WBV) training is an alternative method for muscle strengthening. WBV platforms can generate vertical vibrations that stimulate tonic vibration reflexes through muscle spindles, thereby activating homonymous alpha motor neurons and inducing reflex muscle contractions. As a result, increased motor unit recruitment enhances the excitability of muscle spindles, leading to improved muscle strength. Additionally, WBV training can improve muscle balance, strength, and function. Therefore, combining WBV with hip and knee strengthening exercises may represent a more effective treatment strategy for PFPS. The aim of this study is to evaluate whether the combination of WBV and hip-knee muscle strengthening is more effective in reducing pain and improving function than hip-knee strengthening 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
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Aged between 18 and 40 years,
  • Diagnosed with unilateral Patellofemoral Pain Syndrome (PFPS),
  • Reporting anterior knee pain or pain behind the patella in at least two of the following activities:
  • ascending stairs, jumping, running, squatting, kneeling, prolonged sitting,
  • \- Positive results in at least two of the following clinical tests: Eccentric step-down test, Patellar border tenderness test, Patellar grind (Clarke's) or apprehension test,
  • Ability to understand the procedures, potential benefits, and possible adverse effects,
  • Willingness to participate in the treatment program.

排除标准

  • Severe injury or pathological changes in knee structures (e.g., ligaments, menisci, patellar tendons, iliotibial bands, joint capsules, or plicae),
  • History of significant trauma or surgery involving the knee or lower extremity,
  • History of patellar dislocation or subluxation,
  • Diagnosis of Osgood-Schlatter disease or Sinding-Larsen-Johansson syndrome,
  • Joint effusion in the knee, or presence of redness, swelling, or increased warmth on physical examination,
  • Serious systemic conditions, including cardiovascular diseases, tumors, gallstones or kidney stones, severe disc or spinal lesions, pacemaker implantation, epilepsy, recent fractures or surgeries, or acute arthritis,
  • Pregnancy.

研究组 & 干预措施

Experimental

Experimental

Whole body vibration group, 3 days a week, 30 minutes a day for 8 weeks

干预措施: Whole body vibration (Device)

Sham group

Sham Comparator

Sham-whole body vibration, 3 days a week, 30 minutes a day for 8 weeks

干预措施: Sham Whole Body Vibration (Device)

结局指标

主要结局

VAS

时间窗: Change from baseline VAS at the 8th week after the treatment

Pain is the most characteristic symptom in Patellofemoral Pain Syndrome (PFPS). After recording the duration of pain (in months) for each patient, pain intensity was assessed using the Visual Analog Scale (VAS), which is a 10-centimeter (cm) line anchored by 0 (no pain) and 10 (unbearable pain). Patients were asked to rate their pain at rest, during stair ascent/descent, squatting, prolonged sitting, and walking. Crossley et al. have reported that the VAS is a valid, reliable, and responsive tool for assessing pain in individuals with PFPS

次要结局

  • Anterior Knee Pain Scale(Change from baseline AKPS score at the 8th week after the treatment)
  • Short Form - 36(Change from baseline SF-36 score at the 8th week after the treatment)
  • Muscle Mass Assessment via Ultrasound(Change from baseline muscle mass assessment at the 8th week after the treatment)
  • Change in peak torque at 60°/s (Nm) of the knee muscles measured by isokinetic dynamometer(Change from baseline to Week 8 after treatment)
  • Change in peak torque at 240°/s (Nm) of the knee muscles measured by isokinetic dynamometer(Change from baseline to Week 8 after treatment)
  • Assessment of the hamstring/quadriceps ratio at 60°/s with an isokinetic dynamometer(Change from baseline VAS at the 8th week after the treatment)
  • Assessment of the hamstring/quadriceps ratio at 240°/s with an isokinetic dynamometer(Change from baseline to week 8 after treatment)
  • Change in Total Work (J) of the Knee Muscles at 60°/s With an Isokinetic Dynamometer(Change from baseline to Week 8 after treatment)
  • Change in Total Work (J) of the Knee Muscles at 240°/s With an Isokinetic Dynamometer(Change from baseline to Week 8 after treatment)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Hakan Alkan

Professor Doctor

Pamukkale University

研究点 (1)

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