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Comparing Rehabilitation Programs for Patellofemoral Pain Syndrome

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Timothy Uhl, University of Kentucky
ClinicalTrials.gov Identifier:
NCT00445224
First received: March 6, 2007
Last updated: February 25, 2017
Last verified: February 2017
Results First Received: January 28, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Single (Participant);   Primary Purpose: Treatment
Condition: Patellofemoral Pain Syndrome
Interventions: Other: Hip Progressive Resistive Exercise
Other: Quad Progressive Resistive Exercises

  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 
[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 
Overall Participants Analyzed 
[Units: Participants]
 17   16   33 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      17 100.0%      16 100.0%      33 100.0% 
>=65 years      0   0.0%      0   0.0%      0   0.0% 
Age 
[Units: Years]
Mean (Standard Deviation)
 24.6  (5.3)   25.7  (5.9)   25  (5.5) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      17 100.0%      16 100.0%      33 100.0% 
Male      0   0.0%      0   0.0%      0   0.0% 
Region of Enrollment 
[Units: Participants]
     
United States   17   16   33 


  Outcome Measures
  Hide All Outcome Measures

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  

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 
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  

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 
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
Statistical Test Type [2] Superiority or Other
Statistical Method [3] ANOVA
P Value [4] .049
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Repeated measures ANOVA for group and time
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[4] 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  

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 
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
Statistical Test Type [2] Superiority or Other
Statistical Method [3] ANOVA
P Value [4] .041
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[4] 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 reported.   Anticipated Reporting Date:   No text entered.  

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

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.  

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.  


  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