Comparison of Exercise Therapies for Patellofemoral Pain

NCT03069547 | Completed

• 1 other identifier: FYS-2016-004
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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. 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. 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.

Conditions

Patellofemoral Pain Syndrome

Outcome Measures

Primary Outcomes (1)

• Change from baseline in the KUJALA scoring questionnaire

  The Kujala Patellofemoral Scale - sometimes called the anterior knee pain scale - is disease specific validated disability scale ranging from 0 (complete disability) to 100 (fully functional). It is a 13-item self-report questionnaire that documents response to 6 activities (walking, running, jumping, climbing stairs, squatting, and sitting for prolonged periods with knees bent), as well as symptoms such as limp, inability to weight bear, swelling, abnormal patellar movement, muscle atrophy, and limitations in knee flexion.

  week 12 and 26

Secondary Outcomes (6)

• Change from baseline in the KOOS questionnaire

  Week 12 and 26

• Change fom baseline in isometric muscle strength of hip abductors, hip external rotators, hip extensors, and quadriceps

  Week 12

• Change fom baseline in the Dynamic Assessment of Pain test

  Week 12

• Change fom baseline in the Pain Self-Efficacy Questionnaire

  Week 12 and 26

• Change fom baseline in the EuroQoL Questionnaire

  Week 12 and 26

Other Outcomes (12)

• Candidate prognostic factor: Previous treatments received

  Baseline (week 0)

• Candidate prognostic factor: Presence of bilateral knee pain

  Baseline (week 0)

• Candidate prognostic factor: Presence of pain in other lower extremity joints (feet, ankles, hips)

  Baseline (week 0)

Study Arms (2)

Quadriceps Exercise program

ACTIVE COMPARATOR

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.

Other: Quadriceps Exercise program

Hip Exercise program

ACTIVE COMPARATOR

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.

Other: Hip Exercise program

Interventions

Quadriceps Exercise program 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.

Quadriceps Exercise program

Hip Exercise program 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.

Hip Exercise program

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Marius Henriksen: lead

Study Sites (1)

Bispebjerg Hospital, Department of Physical and Occupational Therapy

Copenhagen, 2400, Denmark

Location

Related Publications (3)

• Hansen R, Rathleff MS, Brushoj C, Magnusson SP, Henriksen M. Differential Effects of Quadriceps and Hip Muscle Exercises for Patellofemoral Pain: A Secondary Effect Modifier Analysis of a Randomized Trial. J Orthop Sports Phys Ther. 2024 Nov;54(11):732-742. doi: 10.2519/jospt.2024.12503.

  PMID: 39478429 DERIVED

• Jorgensen JEV, Rathleff MS, Henriksen M, Brushoj C, Hansen R. Physical Therapists' Prognosis of Outcomes After a Hip or Quadriceps Exercise Intervention in Patients With Patellofemoral Pain: A Secondary Analysis of a Randomized Trial. J Orthop Sports Phys Ther. 2024 Aug;54(8):541-550. doi: 10.2519/jospt.2024.12258.

  PMID: 38840581 DERIVED

• Hansen R, Brushoj C, Rathleff MS, Magnusson SP, Henriksen M. Quadriceps or hip exercises for patellofemoral pain? A randomised controlled equivalence trial. Br J Sports Med. 2023 Oct;57(20):1287-1294. doi: 10.1136/bjsports-2022-106197. Epub 2023 May 3.

  PMID: 37137673 DERIVED

MeSH Terms

Conditions

Patellofemoral Pain Syndrome

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases

Study Officials

• Marius Henriksen, PT, PhD

  Department of Physical and Occupational Therapy, Bispebjerg-Frederiksberg Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Model Details: Eligible participants will be randomly assigned (1:1) to one of the two following groups: * QE - quadriceps exercise program * HE - hip exercise program

Study Record Dates

• First Submitted: February 22, 2017
• First Posted: March 3, 2017
• Study Start: April 10, 2017
• Primary Completion: December 3, 2021
• Study Completion: March 3, 2022
• Last Updated: August 2, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will share

Locations

DK (1)