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

February 17, 2016 updated by: Norwegian University of Science and Technology

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 50 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: high exercise
High dose, high repetition exercise therapy, 3 times weekly in 12 weeks
Behavioral: High exercise therapy
Experimental: low exercise
low dose, low repetition exercise therapy, 3 times weekly in 12 weeks
Behavioral: Low exercise therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Pre-test, post-test (after completed intervention at 3 months) and one year follow-up.

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Norwegian University of Science and Technology

Investigators

  • Study Director: Jan Harry Størksen, Norwegian University of Science and Technology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2007

Primary Completion (Actual)

December 1, 2010

Study Completion (Actual)

December 1, 2010

Study Registration Dates

First Submitted

February 4, 2011

First Submitted That Met QC Criteria

February 4, 2011

First Posted (Estimate)

February 7, 2011

Study Record Updates

Last Update Posted (Estimate)

February 18, 2016

Last Update Submitted That Met QC Criteria

February 17, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17790

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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