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临床试验/NCT06893289
NCT06893289尚未招募不适用

The Effect of a Treatment Protocol Focused on Neuromuscular Control Exercises on Pain and Function in a Subgroup of Individuals With Patellofemoral Pain

Universidade do Porto2 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2026年10月1日最近更新:
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
24
试验地点
2
主要终点
Pain at rest

研究概览

简要总结

Patellofemoral Pain (PFP) is one of the most common causes of knee pain and is significantly present in recreational athletes who have previously been categorized as being in a subgroup of PFP. Understanding which intervention is most appropriate for this subgroup could give us important information about subgroup-based treatments, which are not yet described in the literature. Therefore, the aim of this study is to analyze the effect of two exercise interventions in a PFP subgroup: one focusing on neuromuscular control exercises and the other focusing on muscle strengthening.This study will recruit 10 individuals to each exercise group, and will assess pain, function, muscle activity and joint kinematics pre and post intervention. Mixed Model ANOVA tests will be used to determine the responses to the two interventions between the two groups over a 6-week treatment time.

详细描述

This study proposes a treatment protocol focused on neuromuscular control in a subgroup of individuals with PFP and may provide important information on the effectiveness of different treatment approaches for patellofemoral pain. It would be interesting to establish objectives according to clinical findings, and thus identify the best treatment protocols for specific subgroups of PFP. For a long time, the focus of rehabilitation has been on decreasing knee pain and strengthening the muscles around the knee to improve knee joint function (Piva et al., 2009) in a generalized way for all individuals with PFP. However, with recent information in the literature on the presence of subgroups, a study with a treatment protocol focused on neuromuscular control directed at a subgroup has not yet been carried out, which is the objective of this work. Thus, the hypothesis to be tested is that individuals from a PFP subgroup will present better results with neuromuscular control exercises than those performing muscle strengthening in the same treatment period.

The aim of this study is to compare the effects of two 6-week treatment protocols a) based on neuromuscular control exercises, and b) muscle strengthening on outcome measures of pain, function and biomechanical variables in a subgroup of individuals with PFP during stair ascent and descent.

-Detailed Description This study will be carried out at the Porto Biomechanics Laboratory (LABIOMEP) and at the gym of the Faculty of Sports (FADEUP) of University of Porto. The recruitment of volunteers for this project will take place in the city of Porto, Portugal. Participants will be invited to participate in the study if they self-report anterior knee pain exacerbated during a squatting test and/or during any sporting practice. Folders with all the information necessary for recruitment will be distributed among the academic and general community, recreational athletes during sporting events and on social media.

Sample calculation A sample size calculation was performed based on the minimal detectable change on the Visual Analog Pain Scale (VAS). Data from a previous study indicate that the mean VAS score in patients with PFP was 4.3 ± 1 cm (Crossley et al. 2004), with 30% of the maximum score of the VAS-pain considered to be the detectable change. The sample size for each group to achieve a 90% power at the 0.05 level of significance was determined to be 8 patients. Thus, the sample will consist of 20 volunteers (ten per group) of both sexes diagnosed with PFP.

Inclusion criteria Men and women aged 18-40 years old that can give informed written consent. Clinical diagnosis of unilateral or bilateral PFP longer than 3 months (exemplified in the following sections).

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
Single (Participant)

盲法说明

Patients will be blinded to group allocation, ensuring that they will not know which exercises will be performed by the other group, and thus the interventions will be administered separately to members of each treatment group.

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

  • Men and women aged 18-40 years old that can give informed written consent. Clinical diagnosis of unilateral or bilateral PFP longer than 3 months (exemplified in the following sections).
  • Anterior or retropatellar pain reported on at least two of the following activities: prolonged sitting, ascending or descending stairs, running, kneeling and hopping/jumping.
  • At least two of the three following clinical examination findings:
  • Pain during resisted isometric quadriceps contraction
  • Pain with palpation of the posterior borders of the patella
  • Pain during squatting Classified as being within the strong subgroup of PFP (exemplified in the following sections).

排除标准

  • Individuals who are not part of a PFP group
  • Previous knee surgery and participants awaiting surgery for another lower limb joint problems
  • Ligamentous instability and/or internal pathology
  • History of patella subluxation or dislocation
  • Joint effusion when the midpatellar girth is 5% or more than the non-involved knee
  • True knee joint locking and/or giving way
  • Coexistent acute illness or chronic disease
  • Bursitis, patella or iliotibial tract tendinopathy, Osgood-Schlatter's disease, -Sinding-Larsen-Johansson Syndrome, muscle tears or symptomatic knee plicae
  • Pregnancy or breast feeding

研究组 & 干预措施

Neuromuscular control exercises

Experimental

干预措施: Exercise (Other)

Muscle strengthening

Active Comparator

干预措施: Muscle strengthening (Other)

结局指标

主要结局

Pain at rest

时间窗: From enrollment to the end of treatment at 6 weeks

Numerical Pain Rating Scale (NPRS)

Pain during activity

时间窗: From enrollment to the end of treatment at 6 weeks

Numerical Pain Rating Scale (NPRS)

Function

时间窗: From enrollment to the end of treatment at 6 weeks

Knee injury and Osteoarthritis Outcome Score - KOOS

Pain intensity

时间窗: From enrollment to the end of treatment at 6 weeks

Full name: Numerical Pain Rating Scale (NPRS) Minimum value: 0; Maximum value: 10. Direction: Higher scores indicate a worse outcome, that is, greater pain intensity. Interpretation: 0: no pain 1-3: mild pain 4-6: moderate pain 7-10: intense/severe pain

次要结局

  • Kinematic data - hip, knee and ankle angles(From enrollment to the end of treatment at 6 weeks)
  • Kinetic data - hip, knee, and ankle moments and ground reaction forces(From enrollment to the end of treatment at 6 weeks)
  • Muscular activity(From enrollment to the end of treatment at 6 weeks)
  • Knee angles(From enrollment to the end of treatment at 6 weeks)
  • Knee moments(From enrollment to the end of treatment at 6 weeks)
  • Specific Knee Function(From enrollment to the end of treatment at 6 weeks)
  • General function(From enrollment to the end of treatment at 6 weeks)
  • Kinesiophobia(From enrollment to the end of treatment at 6 weeks)
  • Pain Catastrophizing(From enrollment to the end of treatment at 6 weeks)

研究者

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

Ana Luiza Costa e Silva Cabral

PhD candidate

Universidade do Porto

研究点 (2)

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