跳至主要内容
临床试验/NCT02114294
NCT02114294Unknown不适用

Does Isolated Hip Strengthening for Patellofemoral Pain Syndrome Give Better Long Term Results Than Traditional Quadriceps Based Training? A Randomised Controlled Trial.

Sorlandet Hospital HF1 个研究点 分布在 1 个国家目标入组 112 人开始时间: 2014年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
112
试验地点
1
主要终点
Anterior knee pain score

研究概览

简要总结

This is a Randomized Controlled Trial (RCT) regarding conservative treatment of Patellofemoral Pain Syndrome (PFPS). Patellofemoral Pain Syndrome (PFPS) is a very common cause of knee pain in young active adults with a high rate of recurrent and/or chronic occurrence. PFPS is notoriously difficult to treat and has been referred to as "one of the most vexatious clinical challenges in rehabilitative medicine". Its etiology is unclear but is commonly thought to be related to pathomechanics in the patellofemoral joint (PFJ). There are many factors that can influence PFJ mechanics. Among these, quadriceps strength and timing has been shown to be important. As such, treatment of PFPS has traditionally been based on correction of pathomechanics through influencing quadriceps strength and timing. However, a growing body of evidence is revealing the importance of strength and control of hip abduction and external rotation in PFPS. Hip strength in ab/adduction and rotation is thought to influence femoral positioning in the patellofemoral joint, thereby affecting PFJ mechanics. Several cohort and smaller RCT studies within the last 7 years have shown that additional exercises for hip strength and control give an improved effect in pain and function compared with quadriceps based training alone. A smaller RCT from 2012 compared isolated hip strengthening exercises to a control group and found surprisingly good results on pain in function in the hip strengthening group. The investigators plan a RCT in which isolated hip strengthening will be compared to traditional quadriceps training and a control group which will receive no structured training. Primary outcomes will be pain and function. This high-quality study will include 40-50 patients in each group, making it one of the largest of its kind on conservative treatment for PFPS. In contrast to the vast majority of studies of this type, this study will also include men, which will potentially help to fill a significant gap in the literature on this subject. The investigators study will therefore be an important contribution to elucidating the etiology of PFPS and improving treatment options for both men and women in the future. As well, the role of psychometric parameters will be examined and a standardized clinical test for hip abduction endurance will be developed. Follow-up at 3 months and 12 months is completed and published. A 5-year follow-up of the same patients is underway.

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 (Investigator, Outcomes Assessor)

入排标准

年龄范围
16 Years 至 40 Years(Child, Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Age 16-40 years
  • •Insidious onset of symptoms not related to trauma
  • •Symptoms more than 3 months
  • •A minimum of VAS 3 on VAS-W
  • •Peri- or retropatellar pain during or after at least two of the following: Stair ascent or descent, hopping, running, prolonged sitting, squatting, kneeling.
  • •Pain on one of the following: Compression of the patella, palpation of the patellar facets

排除标准

  • •Clinical findings indicative of meniscal or other intraarticular injury
  • •Clinical findings indicative of injury to or increased laxity of cruciate or collateral ligaments
  • •Findings on MRI indicative of other intraarticular pathology.
  • •Clinical and/or x-ray findings (plain anterior-posterior, lateral and skyline view) indicative of osteoarthritis, Osgood-Schlatter or Sinding-Larsen-Johanssen syndrome
  • •Clinical findings indicative of knee joint effusion
  • •Significant pain from hip or lumbar spine on clinical evaluation, with potential for causing referred pain to the knee or hindering the patient's ability to perform the prescribed exercises.
  • •Recurrent patellar subluxation or dislocation.
  • •Previous surgery to the knee joint
  • •NSAID or cortisone use over an extended period of time
  • •Having suffered trauma to the knee joint judged during clinical evaluation to have a significant effect on the presenting clinical condition.
  • •Physiotherapy or other similar treatment for patellofemoral pain syndrome within the previous 3 months

研究组 & 干预措施

Isolated hip strengthening

Experimental

Isolated hip strengthening (abduction, external rotation, extension)

干预措施: Isolated hip strengthening (Other)

Quadriceps based training

Active Comparator

Quadriceps based training (mini-squat, straight leg raising, terminal extensions)

干预措施: Quadriceps based training (Other)

Active control

Other

Patients receive standardised information concerning patellofemoral pain syndrome, but receive no prescribed exercise regime. They are encouraged to remain active.

干预措施: Active control (Other)

结局指标

主要结局

Anterior knee pain score

时间窗: 3 months

Anterior Knee Pain Score (AKPS) is a measurement of subjective symptoms and functional limitations in patellofemoral pain, and has been validated for use in this patient population. The AKPS consists of a 13-point questionnaire with categories related to different levels of function in the knee. The categories within each question are weighted, and the responses are summed for an overall index where 100 represents perfect function. The mean clinically important difference (MCID) has been determined to be 10 points. This questionnaire will be translated to Norwegian and validated according to standard scientific procedures with approval from Kuala et al.

次要结局

  • EQ 5D 5L(3 months)
  • Knee self-efficacy score (K-SES)(3 months)
  • Visual Analog Scale (VAS)(3 months)
  • Global Score Global Score(3 months)
  • Hip abduction, external rotation and knee extension strength(3 months)
  • Hip abduction endurance(3 months)
  • Step-down test(3 months)
  • Tampa scale for kinesiophobia(3 months)
  • HSCL-10(3 months)
  • Pain drawing with number of painful regions(3 months)

研究者

发起方
Sorlandet Hospital HF
申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

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