NCT00445224

Brief Summary

Patellofemoral pain syndrome (PFPS) is a common knee disorder affecting physically active people. Despite the growing base of support for the early introduction of hip strengthening exercises into the rehabilitation of PFPS, there have been few randomized clinical trials comparing isolated hip to isolated quadriceps strengthening. The purpose of this study is to determine how different exercises affect pain, strength, muscle activity, and function in female subjects with patellofemoral pain. The researchers hypothesize that females diagnosed with PFPS who initially participate in a hip strengthening program will report a greater perceived level of function, greater strength, less pain, and improved neuromuscular activity than those who participate in a progressive quadriceps strengthening intervention.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
33

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2008

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

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

First Submitted

Initial submission to the registry

March 6, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 8, 2007

Completed
10 months until next milestone

Study Start

First participant enrolled

January 1, 2008

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2010

Completed
7 months until next milestone

Results Posted

Study results publicly available

August 5, 2010

Completed
Last Updated

March 28, 2017

Status Verified

February 1, 2017

Enrollment Period

2 years

First QC Date

March 6, 2007

Results QC Date

January 28, 2010

Last Update Submit

February 25, 2017

Conditions

Keywords

Knee painRehabilitation

Outcome Measures

Primary Outcomes (3)

  • Visual Analog Pain Scale (Describing Worst Pain Felt During the Past Week)

    0 to 10 cm line with 0 representing no pain and 10 representing severe pain

    weekly

  • Subjective Function by Lower Extremity Functional Scale Report Form

    Baseline, Mid-Intervention, and Post-Intervention

  • Visual Analog Pain Scale

    Visual analog pain scale at end of intervention. 0 to 10 cm line with 0 representing no pain and 10 representing severe pain

    8 week

Secondary Outcomes (4)

  • Strength by Isometric Dynamometer

    Baseline, Mid, and Post-Intervention

  • Neuromuscular Activity by Surface Electromyographical Amplitude During Stair Descent

    Baseline, Mid and Post-Intervention

  • Objective Function by Step-down Task for 30 Seconds

    Baseline, Mid, and Post-Intervention

  • Hip Abduction Strength

    8 week

Study Arms (2)

Hip Progressive Resistive Exercises

EXPERIMENTAL

Exercises targeting hip musculature such as hip abduction and hip external rotation that was progressed by increased resistance following typical progressive resistive exercise approach.

Other: Hip Progressive Resistive Exercise

Quad Progressive Resistive Exercises

ACTIVE COMPARATOR

Exercises targeting quadriceps musculature such as quadriceps isometric setting, terminal knee extensions, and straight leg raises that was progressed by increased resistance following typical progressive resistive exercise approach..

Other: Quad Progressive Resistive Exercises

Interventions

Hip Progressive Resistance Exercise program will be carried out by subjects under supervision once a week and then performed at home 2 additional times at home without supervision. Exercises focus on strengthening hip abduction ad external rotation musculature.

Hip Progressive Resistive Exercises

Quad Progressive Resistive Exercise program will be carried out by subjects under supervision once a week and then performed at home 2 additional times at home without supervision. Exercises focus on strengthening quadriceps musculature with straight leg raises and quadriceps isometrics.

Quad Progressive Resistive Exercises

Eligibility Criteria

Age15 Years - 35 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • anterior or retropatellar knee pain reported during at least 2 of the following activities: ascending and descending stairs, hopping and running, squatting, kneeling, and prolonged sitting
  • insidious onset of symptoms not related to trauma
  • pain with compression of the patella
  • pain on palpation of the patellar facets

You may not qualify if:

  • symptoms present for less than one month
  • clinical evidence of other knee pathology
  • history of recent knee surgery within past one year
  • history of patellar dislocations or subluxations
  • current significant injury affecting other lower extremity joints

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Kentucky

Lexington, Kentucky, 40506, United States

Location

Related Publications (1)

  • Dolak KL, Silkman C, Medina McKeon J, Hosey RG, Lattermann C, Uhl TL. Hip strengthening prior to functional exercises reduces pain sooner than quadriceps strengthening in females with patellofemoral pain syndrome: a randomized clinical trial. J Orthop Sports Phys Ther. 2011 Aug;41(8):560-70. doi: 10.2519/jospt.2011.3499. Epub 2011 Jun 7.

MeSH Terms

Conditions

Patellofemoral Pain Syndrome

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal Diseases

Limitations and Caveats

Early termination leading to small number of subjects analyzed. Intention to treat analysis, last score carried forward, was used to analyze all outcome data.

Results Point of Contact

Title
Dr. Tim L. Uhl Principal Investigator
Organization
University of Kentucky

Study Officials

  • Timothy Uhl, PhD, ATC, PT

    University of Kentucky

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 6, 2007

First Posted

March 8, 2007

Study Start

January 1, 2008

Primary Completion

January 1, 2010

Study Completion

January 1, 2010

Last Updated

March 28, 2017

Results First Posted

August 5, 2010

Record last verified: 2017-02

Locations