Comparing Rehabilitation Programs for Patellofemoral Pain Syndrome

This study has been completed.
Sponsor:
Information provided by:
University of Kentucky
ClinicalTrials.gov Identifier:
NCT00445224
First received: March 6, 2007
Last updated: August 4, 2010
Last verified: August 2010
Results First Received: January 28, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Crossover Assignment;   Masking: Single Blind (Subject);   Primary Purpose: Treatment
Condition: Patellofemoral Pain Syndrome
Intervention: Procedure: Therapeutic Exercise

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
33 females with anterior knee pain (PFPS) volunteered to participate in this study. Enrollment began August 2007 and last subject was enrolled in August 2009.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Subjects were evaluated for PFPS using the following:(1)anterior knee pain reported during at least 2 activities: stair climbing, running, squatting, kneeling, and prolonged sitting;(2)insidious onset of symptoms ;(3)pain with compression of the patella; and(4)pain on palpation of patellar facets. Only three patients were excluded during study.

Reporting Groups
  Description
Hip Strengthening Then Combined Exercises Performed hip strengthening exercises for 4 weeks prior to crossing over to a combined hip and quadricep rehabilitation program
Quadricep Group Then Combined Exercises Performed quadricep strengthening exercises for 4 weeks prior to crossing over to a combined hip and quadricep rehabilitation program

Participant Flow for 2 periods

Period 1:   Specific Exercises
    Hip Strengthening Then Combined Exercises     Quadricep Group Then Combined Exercises  
STARTED     17     16  
Baseline     17     16  
4 Weeks     14 [1]   13 [1]
COMPLETED     13 [2]   13 [2]
NOT COMPLETED     4     3  
Withdrawal by Subject                 3                 3  
Withdrawal by Subject                 1                 0  
Withdrawal by Subject                 0                 0  
[1] Participants withdrew due to time conflicts
[2] No adverse event occurred

Period 2:   Combined Exercises
    Hip Strengthening Then Combined Exercises     Quadricep Group Then Combined Exercises  
STARTED     13     13  
COMPLETED     13     13  
NOT COMPLETED     0     0  



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Hip Strengthening Then Combined Exercises Performed hip strengthening exercises for 4 weeks prior to crossing over to a combined hip and quadricep rehabilitation program
Quadricep Group Then Combined Exercises Performed quadricep strengthening exercises for 4 weeks prior to crossing over to a combined hip and quadricep rehabilitation program
Total Total of all reporting groups

Baseline Measures
    Hip Strengthening Then Combined Exercises     Quadricep Group Then Combined Exercises     Total  
Number of Participants  
[units: participants]
  17     16     33  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     17     16     33  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  24.6  ± 5.3     25.7  ± 5.9     25  ± 5.5  
Gender  
[units: participants]
     
Female     17     16     33  
Male     0     0     0  
Region of Enrollment  
[units: participants]
     
United States     17     16     33  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Visual Analog Pain Scale (Describing Worst Pain Felt During the Past Week)   [ Time Frame: weekly ]

2.  Primary:   Visual Analog Pain Scale   [ Time Frame: 8 week ]

3.  Secondary:   Hip Abduction Strength   [ Time Frame: 8 week ]

4.  Primary:   Subjective Function by Lower Extremity Functional Scale Report Form   [ Time Frame: Baseline, Mid-Intervention, and Post-Intervention ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

5.  Secondary:   Strength by Isometric Dynamometer   [ Time Frame: Baseline, Mid, and Post-Intervention ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

6.  Secondary:   Neuromuscular Activity by Surface Electromyographical Amplitude During Stair Descent   [ Time Frame: Baseline, Mid and Post-Intervention ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

7.  Secondary:   Objective Function by Step-down Task for 30 Seconds   [ Time Frame: Baseline, Mid, and Post-Intervention ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Early termination leading to small number of subjects analyzed. Intention to treat analysis, last score carried forward, was used to analyze all outcome data.


  More Information
  Hide More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Tim L. Uhl Principal Investigator
Organization: University of Kentucky
phone: 859-323-1100 ext 80858
e-mail: tluhl2@uky.edu


No publications provided by University of Kentucky

Publications automatically indexed to this study:

Responsible Party: Tim Uhl/Principal Investigator, University of Kentucky
ClinicalTrials.gov Identifier: NCT00445224     History of Changes
Other Study ID Numbers: 07-0138-F2L
Study First Received: March 6, 2007
Results First Received: January 28, 2010
Last Updated: August 4, 2010
Health Authority: United States: Institutional Review Board