Comparison of Exercise Therapies for Patellofemoral Pain (COMPETE)

Marius Henriksen

Status: Completed

Conditions: Patellofemoral Pain Syndrome

Treatments: Other: Hip Exercise program; Other: Quadriceps Exercise program

Study type: Interventional

Funder types: Other

Identifiers

NCT03069547

FYS-2016-004

Details and patient eligibility

About

Patellofemoral Pain (PFP) is a common knee problem, primarily affecting adolescents and young adults. PFP is characterised by significant retropatellar and/or peripatellar pain and impairment of function and quality of daily life. Exercise therapy is unequivocally recommended as a core component of the management of PFP. Different exercise types (e.g. quadriceps strengthening, hip strengthening and functional/neuromuscular exercises) have been investigated, with knee and hip strengthening exercises as the most common and recommended types. These exercises approaches produce similar small to moderate effects on pain and physical function. However, the PFP population is very heterogeneous and "one-size-fits-all"-approaches presumably are sub-optimal because the heterogeneity is ignored. The heterogeneity probably explains the overall limited beneficial effects of exercise, and the lack of differences in direct comparisons of different exercise types. In that sense, it is not unlikely that certain patient characteristics may predict outcome success of either a hip training program or a training program that focus on the quadriceps but this remains to be shown.

This study has two aims:

1. To assess the comparative effectiveness of two different exercise programs (Quadricep Exercise [QE] vs. Hip Exercise [HE]) on self-reported pain and function in individuals with PFP.
2. To explore candidate patient characteristics that predict differential responses to the two exercise programs (QE vs HE) on self-reported pain and physical function in individuals with PFP.

According to the study aims we pursue the following hypothesis:

• QE and HE have equivalent efficacy on self-reported pain after 12 weeks of treatment in patients with PFP.

The second study aim is to explore possible candidate patient characteristics that may associate with differential outcomes. As this is exploratory, the pursuit of this aim is hypothesis-free.

Enrollment: 200 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• A clinical diagnosis of PFP in at least one knee

• Visual analogue score rating of pain during activities of daily living during the previous week at a minimum of 3 on a 10 cm scale.

• Insidious onset of symptoms unrelated to trauma and persistent for at least 4 weeks.

• Pain in the anterior knee associated with at least 3 of the following:

  • During or after activity
  • Prolonged sitting
  • Stair ascent or descent
  • Squatting

Exclusion criteria

• Meniscal or other intra-articular injury
• Cruciate or collateral ligament laxity or tenderness
• Patellar tendon, iliotibial band, or pes anserine tenderness
• Osgood-Schlatter or Sinding-Larsen-Johansson syndrome
• History of recurrent patellar subluxation or dislocation
• History of surgery to the knee joint
• History of head injury or vestibular disorder within the last 6 months

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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200 participants in 2 patient groups

Quadriceps Exercise program

Active Comparator group

Description:

The Quadricepts Exercise (QE) program runs for 12 weeks, with exercise sessions 3 times per week. Each training session is scheduled to last approximately 30 minutes. The exercise program is home based with monthly supervision visits at the clinic.

Treatment:

Other: Quadriceps Exercise program

Hip Exercise program

Active Comparator group

Description:

The Hip Exercise (HE) program runs for 12 weeks, with exercise sessions 3 times per week. Each training session is scheduled to last approximately 30 minutes. The exercise program is home based with monthly supervision visits at the clinic.

Treatment:

Other: Hip Exercise program