NCT01290705

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2007

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2007

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 4, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 7, 2011

Completed
Last Updated

February 18, 2016

Status Verified

February 1, 2016

Enrollment Period

3.1 years

First QC Date

February 4, 2011

Last Update Submit

February 17, 2016

Conditions

Keywords

KneeAnterior Cruciate LigamentPainPatellaExercise Therapy

Outcome Measures

Primary Outcomes (1)

  • 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.

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

Secondary Outcomes (1)

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

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

Study Arms (2)

high exercise

EXPERIMENTAL

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

Behavioral: High exercise therapy

low exercise

EXPERIMENTAL

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

Behavioral: Low exercise therapy

Interventions

high exercise
low exercise

Eligibility Criteria

Age16 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • 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.

  • 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.

MeSH Terms

Conditions

Patellofemoral Pain SyndromePainPatella Fracture

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsKnee FracturesFractures, BoneWounds and Injuries

Study Officials

  • Jan Harry Størksen

    Norwegian University of Science and Technology

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 4, 2011

First Posted

February 7, 2011

Study Start

November 1, 2007

Primary Completion

December 1, 2010

Study Completion

December 1, 2010

Last Updated

February 18, 2016

Record last verified: 2016-02