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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Norwegian University of Science and Technology
ClinicalTrials.gov Identifier:
NCT01290705
First received: February 4, 2011
Last updated: February 17, 2016
Last verified: February 2016
  Purpose
With this study two different therapeutic exercise regimens will be compared in patients with anterior knee pain (patellofemoral pain syndrome, PFPS).

Condition Intervention
Patellofemoral Pain Syndrome
Behavioral: High exercise therapy
Behavioral: Low exercise therapy

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 Norwegian University of Science and Technology:

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: 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

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.

  Eligibility

Ages Eligible for Study:   16 Years to 50 Years   (Child, Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01290705

Sponsors and Collaborators
Norwegian University of Science and Technology
Investigators
Study Director: Jan Harry Størksen Norwegian University of Science and Technology
  More Information

Publications:
Responsible Party: Norwegian University of Science and Technology
ClinicalTrials.gov Identifier: NCT01290705     History of Changes
Other Study ID Numbers: 17790 
Study First Received: February 4, 2011
Last Updated: February 17, 2016
Health Authority: Norway:National Committee for Medical and Health Research Ethics
Individual Participant Data  
Plan to Share IPD: Undecided

Keywords provided by Norwegian University of Science and Technology:
Knee
Anterior Cruciate Ligament
Pain
Patella
Exercise Therapy

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

ClinicalTrials.gov processed this record on August 22, 2016