Clinical trial NCT03069547: Comparison of Exercise Therapies for Patellofemoral Pain
Official title: Comparative Effectiveness of Therapeutic Hip and Knee Exercise for Atellofemoral Pain: A Pragmatic Randomised Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Patellofemoral Pain Syndrome
Lead sponsor: Frederiksberg University Hospital
Sponsor class: OTHER
First posted: 2017-03-03
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Eligible participants will be randomly assigned (1:1) to one of the two following groups:

* QE - quadriceps exercise program
* HE - hip exercise program
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline in the KUJALA scoring questionnaire
timeFrame: week 12 and 26
Secondary outcomes:
measure: Change from baseline in the KOOS questionnaire
timeFrame: Week 12 and 26
measure: Change fom baseline in isometric muscle strength of hip abductors, hip external rotators, hip extensors, and quadriceps
timeFrame: Week 12
measure: Change fom baseline in the Dynamic Assessment of Pain test
timeFrame: Week 12
measure: Change fom baseline in the Pain Self-Efficacy Questionnaire
timeFrame: Week 12 and 26
measure: Change fom baseline in the EuroQoL Questionnaire
timeFrame: Week 12 and 26
measure: Transition Questionnaire of global perceived effect on overall health, pain, and function
timeFrame: Week 12 and 26
Other outcomes:
measure: Candidate prognostic factor: Previous treatments received
timeFrame: Baseline (week 0)
measure: Candidate prognostic factor: Presence of bilateral knee pain
timeFrame: Baseline (week 0)
measure: Candidate prognostic factor: Presence of pain in other lower extremity joints (feet, ankles, hips)
timeFrame: Baseline (week 0)
measure: Candidate prognostic factor: Presence of low back pain
timeFrame: Baseline (week 0)
measure: Candidate prognostic factor: PainDetect questionnaire
timeFrame: Baseline (week 0)
measure: Candidate prognostic factor: Exercise Self-Efficacy Questionnaire
timeFrame: Baseline (week 0)
measure: Candidate prognostic factor: Pain Catastrophizing Scale
timeFrame: Baseline (week 0)
measure: Candidate prognostic factor: Hyper mobility
timeFrame: Baseline (week 0)
measure: Candidate prognostic factor: Knee joint alignment during a forward lunge
timeFrame: Baseline (week 0)
measure: Candidate prognostic factor: Knee joint alignment during a single-leg mini-squat
timeFrame: Baseline (week 0)
measure: Candidate prognostic factor: Physiotherapist assessed prognosis for the participant based on group allocation
timeFrame: Baseline (week 0)
measure: Candidate prognostic factor: Midfoot mobility
timeFrame: Baseline (week 0)
Locations:
city: Copenhagen
country: Denmark
facility: Bispebjerg Hospital, Department of Physical and Occupational Therapy
Study officials:
affiliation: Department of Physical and Occupational Therapy, Bispebjerg-Frederiksberg Hospital
name: Marius Henriksen, PT, PhD
role: STUDY_CHAIR
References: