Comparison of Exercise Therapies for Patellofemoral Pain

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-10

Study Completion Date

2022-03-03

Brief Summary

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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.

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Detailed Description

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Conditions

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Patellofemoral Pain Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Eligible participants will be randomly assigned (1:1) to one of the two following groups:

* QE - quadriceps exercise program
* HE - hip exercise program

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Investigators, study coordinators, outcome assessors, clinical staff, study staff, and other personnel directly involved in the clinical activities of the study, will be blinded to the group allocation.

Participants and providers of the exercise delivery are not blinded to the group allocation.

Study Groups

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Quadriceps Exercise program

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.

Group Type ACTIVE_COMPARATOR

Quadriceps Exercise program

Intervention Type OTHER

The exercise program is initiated at an individual clinical visit. An experienced physiotherapist introduces the participant to the exercise program and provides instructions to the individual exercises. An experienced physiotherapist provides the monthly supervision visits.

The program details can be requested rom the responsible party. In brief the QE-program consists of:

\- A short warm-up and 3 specific exercises for the quadriceps muscle

Progression of the exercise intensity is done by adding (additional) external loads, such as elastic rubber bands, free weights, etc.

Hip Exercise program

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.

Group Type ACTIVE_COMPARATOR

Hip Exercise program

Intervention Type OTHER

The exercise program is initiated at an individual clinical visit. An experienced physiotherapist introduces the participant to the exercise program and provides instructions to the individual exercises. An experienced physiotherapist provides the monthly supervision visits.

The program details be requested rom the responsible party. In brief the HE-program consists of:

\- A short warm-up and 3 specific exercises for the hip abductor and extensor muscles

Progression of the exercise intensity is done by adding (additional) external loads, such as elastic rubber bands, body weight etc.

Interventions

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Quadriceps Exercise program

The exercise program is initiated at an individual clinical visit. An experienced physiotherapist introduces the participant to the exercise program and provides instructions to the individual exercises. An experienced physiotherapist provides the monthly supervision visits.

The program details can be requested rom the responsible party. In brief the QE-program consists of:

\- A short warm-up and 3 specific exercises for the quadriceps muscle

Progression of the exercise intensity is done by adding (additional) external loads, such as elastic rubber bands, free weights, etc.

Intervention Type OTHER

Hip Exercise program

The exercise program is initiated at an individual clinical visit. An experienced physiotherapist introduces the participant to the exercise program and provides instructions to the individual exercises. An experienced physiotherapist provides the monthly supervision visits.

The program details be requested rom the responsible party. In brief the HE-program consists of:

\- A short warm-up and 3 specific exercises for the hip abductor and extensor muscles

Progression of the exercise intensity is done by adding (additional) external loads, such as elastic rubber bands, body weight etc.

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No