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NCT Number: NCT01290705

Dosage-dependence of Graded Exercise Therapy in Patients With Patellofemoral Pain Syndrome.

With this study two different therapeutic exercise regimens will be compared in patients with anterior knee pain (patellofemoral pain syndrome, PFPS).

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Key information

Conditions

Patellofemoral Pain Syndrome Fractures, Bone Joint Diseases Knee Fractures Musculoskeletal Diseases Neurologic Manifestations Pain Patella Fracture Pathological Conditions, Signs and Symptoms Signs and Symptoms Wounds and Injuries

Age range

16 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

Exercise therapy is widely used in the conservative treatment of patellofemoral pain syndrome (PFPS), but there is still no consensus on recommending any specific rehabilitation program.

This study evaluates two different therapeutic exercise regimens in patients with PFPS and their effect on pain at rest and function.

Supervised exercise therapy will be applied in both groups three times a week over a 3-month period with individually tailored and graded exercise programs, differing between groups in terms of number of exercises, number of repetitions and sets, and time spent on performing aerobic exercises.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Presence of at least 3 symptoms of the following:

Pain when

  • Walking stairs
  • Squatting
  • Running
  • Cycling
  • Sitting with knees flexed for a prolonged period of time
  • Grinding of the patella
  • Other positive physical tests (Clarke's test, patellar crepitus, tenderness upon palpation of the posterior surface of the patella, patellar facets or surrounding structures)

Exclusion criteria

  • Knee osteoarthrosis/ arthritis
  • previous knee injury or knee operations
  • patellar tendinopathy
  • Osgood- Schlatter's disease
  • Other defined pathological conditions of the knee

Treatment and study plan

High exercise therapy

Behavioral

Low exercise therapy

Behavioral

Primary outcomes

  1. Pain measured by a Visual analogue scale (VAS).

    Time frame: Pre-test, post-test (after completed intervention at 3 months) and one year follow-up.

    This scale was illustrated with a 100 mm horizontal line with descriptors "no pain" at the 0 mm mark and "worst pain imaginable" anchoring the 100 mm. Participants were required to place a vertical mark on the horizontal line, representing their average level of pain experienced during the last 24 hours. This was done at rest and provided an illustration of the perceived pain severity, rated in millimetres.

Secondary outcomes

  1. Function measured by a Step-down test and by a modified Functional Index Questionnaire (FIQ).

    Time frame: Pre-test, post-test (at 3 months after completed intervention) and at one year follow-up.

Sponsors and collaborators

Lead sponsor

Norwegian University of Science and Technology

Other

Registry information

Official study title

Dosage-dependence of Graded Exercise Therapy in Patients With Patellofemoral Pain Syndrome. A Randomized Controlled Clinical Trial.

Important dates

Study start
2007
Primary completion
2010
Study completion
2010
First posted
Feb 7, 2011
Registry last updated
Feb 18, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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