search
Back to results

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

Primary Purpose

Patellofemoral Pain Syndrome

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
High exercise therapy
Low exercise therapy
Sponsored by
Norwegian University of Science and Technology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Patellofemoral Pain Syndrome focused on measuring Knee, Anterior Cruciate Ligament, Pain, Patella, Exercise Therapy

Eligibility Criteria

16 Years - 50 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    high exercise

    low exercise

    Arm Description

    High dose, high repetition exercise therapy, 3 times weekly in 12 weeks

    low dose, low repetition exercise therapy, 3 times weekly in 12 weeks

    Outcomes

    Primary Outcome Measures

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

    Full Information

    First Posted
    February 4, 2011
    Last Updated
    February 17, 2016
    Sponsor
    Norwegian University of Science and Technology
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT01290705
    Brief Title
    Dosage-dependence of Graded Exercise Therapy in Patients With Patellofemoral Pain Syndrome.
    Official Title
    Dosage-dependence of Graded Exercise Therapy in Patients With Patellofemoral Pain Syndrome. A Randomized Controlled Clinical Trial.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    November 2007 (undefined)
    Primary Completion Date
    December 2010 (Actual)
    Study Completion Date
    December 2010 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Norwegian University of Science and Technology

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Patellofemoral Pain Syndrome
    Keywords
    Knee, Anterior Cruciate Ligament, Pain, Patella, Exercise Therapy

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    40 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    high exercise
    Arm Type
    Experimental
    Arm Description
    High dose, high repetition exercise therapy, 3 times weekly in 12 weeks
    Arm Title
    low exercise
    Arm Type
    Experimental
    Arm Description
    low dose, low repetition exercise therapy, 3 times weekly in 12 weeks
    Intervention Type
    Behavioral
    Intervention Name(s)
    High exercise therapy
    Intervention Type
    Behavioral
    Intervention Name(s)
    Low exercise therapy
    Primary Outcome Measure Information:
    Title
    Pain measured by a Visual analogue scale (VAS).
    Description
    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.
    Time Frame
    Pre-test, post-test (after completed intervention at 3 months) and one year follow-up.
    Secondary Outcome Measure Information:
    Title
    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.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    16 Years
    Maximum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Jan Harry Størksen
    Organizational Affiliation
    Norwegian University of Science and Technology
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    Citations:
    PubMed Identifier
    23764516
    Citation
    Osteras B, Osteras H, Torstensen TA. Long-term effects of medical exercise therapy in patients with patellofemoral pain syndrome: results from a single-blinded randomized controlled trial with 12 months follow-up. Physiotherapy. 2013 Dec;99(4):311-6. doi: 10.1016/j.physio.2013.04.001. Epub 2013 Jun 10. Erratum In: Physiotherapy. 2014 Mar;100(1):e1. Torsensen, Tom Arild [corrected to Torstensen, Tom Arild].
    Results Reference
    result
    PubMed Identifier
    23219636
    Citation
    Osteras B, Osteras H, Torstensen TA, Vasseljen O. Dose-response effects of medical exercise therapy in patients with patellofemoral pain syndrome: a randomised controlled clinical trial. Physiotherapy. 2013 Jun;99(2):126-31. doi: 10.1016/j.physio.2012.05.009. Epub 2012 Jul 24.
    Results Reference
    result

    Learn more about this trial

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

    We'll reach out to this number within 24 hrs