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

Measure Type Primary
Measure Title Visual Analog Pain Scale (Describing Worst Pain Felt During the Past Week)
Measure Description 0 to 10 cm line with 0 representing no pain and 10 representing severe pain
Time Frame weekly  
Safety Issue No  

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

Measured Values
    Hip Strengthening Then Combined Exercises     Quadricep Group Then Combined Exercises  
Number of Participants Analyzed  
[units: participants]
  17     16  
Visual Analog Pain Scale (Describing Worst Pain Felt During the Past Week)  
[units: centimeter]
Mean ± Standard Deviation
  4.5  ± 2.5     4.2  ± 2.2  

No statistical analysis provided for Visual Analog Pain Scale (Describing Worst Pain Felt During the Past Week)



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

Measure Type Primary
Measure Title Visual Analog Pain Scale
Measure Description Visual analog pain scale at end of intervention. 0 to 10 cm line with 0 representing no pain and 10 representing severe pain
Time Frame 8 week  
Safety Issue No  

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

Measured Values
    Hip Strengthening Then Combined Exercises     Quadricep Group Then Combined Exercises  
Number of Participants Analyzed  
[units: participants]
  17     16  
Visual Analog Pain Scale  
[units: centimeters]
Mean ± Standard Deviation
  2.4  ± 2.8     2.6  ± 2.0  


Statistical Analysis 1 for Visual Analog Pain Scale
Groups [1] All groups
Method [2] ANOVA
P Value [3] .049
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Repeated measures ANOVA for group and time
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.



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

Measure Type Secondary
Measure Title Hip Abduction Strength
Measure Description Side lying Hip Abduction maximal muscular contraction with a hand held dynamometer
Time Frame 8 week  
Safety Issue No  

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

Measured Values
    Hip Strengthening Then Combined Exercises     Quadricep Group Then Combined Exercises  
Number of Participants Analyzed  
[units: participants]
  17     16  
Hip Abduction Strength  
[units: (Newton*meters)/(Weight*Height)]
Mean ± Standard Deviation
  6.6  ± .9     6.2  ± 1.8  


Statistical Analysis 1 for Hip Abduction Strength
Groups [1] All groups
Method [2] ANOVA
P Value [3] .041
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.



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

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


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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.


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