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

This study has been completed.
Sponsor:
Information provided by:
Sør-Trøndelag University College
ClinicalTrials.gov Identifier:
NCT01290705
First received: February 4, 2011
Last updated: NA
Last verified: November 2007
History: No changes posted
  Purpose

The purpose of this study was to evaluate two different therapeutic exercise regimens in patients with anterior knee pain (patellofemoral pain syndrome, PFPS).


Condition Intervention Phase
Patellofemoral Pain Syndrome
Behavioral: Exercise therapy
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Dosage-dependence of Graded Exercise Therapy in Patients With Patellofemoral Pain Syndrome. A Randomized Controlled Clinical Trial.

Resource links provided by NLM:


Further study details as provided by Sør-Trøndelag University College:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]

Enrollment: 40
Study Start Date: November 2007
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Rehabilitation
Clinical intervention study, physiotherapy treatment
Behavioral: Exercise therapy
High dosage Medical Exercise Therapy.

Detailed Description:

Background: 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.

Purpose: This study evaluated two different therapeutic exercise regimens in patients with PFPS.

Design: This was a multicenter randomized controlled clinical trial. Subjects: 40 patients were included in the analyses; n=21 in the experimental group and n=19 in the control group.

Interventions: Supervised exercise therapy was 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. The variables were graded high in the experimental and low (in accordance with traditional procedures) in the control group.

Main outcome measures: Primary outcomes were pain (average last 24 hours) at rest measured by a visual analogue scale (VAS), and function measured both by a Step-down test and with a Functional Index Questionnaire (FIQ).

Main statistical analysis: Main comparative analyses were accomplished using a general linear model. Differences between groups at final were adjusted for baseline values of the primary outcomes.

  Eligibility

Ages Eligible for Study:   16 Years to 50 Years
Genders Eligible for Study:   Both
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided by Sør-Trøndelag University College

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Berit Østerås, Sør-Trøndelag University College
ClinicalTrials.gov Identifier: NCT01290705     History of Changes
Other Study ID Numbers: 17790
Study First Received: February 4, 2011
Last Updated: February 4, 2011
Health Authority: Norway: the Data Protection Official for Research, Norwegian Social Science Data Services.

Keywords provided by Sør-Trøndelag University College:
Knee
Anterior
Pain
Longlasting
Patella

Additional relevant MeSH terms:
Somatoform Disorders
Patellofemoral Pain Syndrome
Mental Disorders
Joint Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on August 01, 2014