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Botox for Non-surgical Lateral Release in Patellofemoral Pain
This study has been terminated.
( Insufficient recruitment in a reasonable time + expiration of study medication )
Study NCT00496964   Information provided by Virginia Commonwealth University

First Received on July 5, 2007.   Last Updated on April 22, 2011   History of Changes
Results First Received: March 14, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Patellofemoral Pain Syndrome
Interventions: Drug: Botulinum toxin A + exercise
Drug: Placebo

  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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Botulinum Toxin A Injection + Exercise Injection of Botulinum toxin A into vastus lateralis of study limb plus exercise program
Placebo Injection + Exercise Placebo injection into Vastus Lateralis + exercise

Participant Flow:   Overall Study
    Botulinum Toxin A Injection + Exercise     Placebo Injection + Exercise  
STARTED     1     4  
COMPLETED     1     3  
NOT COMPLETED     0     1  
Withdrawal by Subject                 0                 1  



  Baseline Characteristics
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Reporting Groups
  Description
Botulinum Toxin A Injection + Exercise Injection of Botulinum toxin A into vastus lateralis of study limb plus exercise program
Placebo Injection + Exercise Placebo injection into Vastus Lateralis + exercise

Baseline Measures
    Botulinum Toxin A Injection + Exercise     Placebo Injection + Exercise     Total  
Number of Participants  
[units: participants]
 		  1     4     5  
Age  
[units: participants]
 		     
<=18 years     0     0     0  
Between 18 and 65 years     1     4     5  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation 		  33     25.5  ± 2.53     27.0  ± 2.47  
Gender  
[units: participants]
 		     
Female     1     4     5  
Male     0     0     0  
Region of Enrollment  
[units: participants]
 		     
United States     1     4     5  



  Outcome Measures
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1.  Primary:   Visual Analog Scale Pain Ratings (VAS)   [ Time Frame: 4, 6, 12 weeks ]
  Show Outcome Measure 1

2.  Primary:   Change in Anterior Knee Pain Scale.   [ Time Frame: 4, 6, 12 weeks ]
  Show Outcome Measure 2

3.  Primary:   Functional Index Questionnaire   [ Time Frame: 4, 6, 12 weeks ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

4.  Primary:   Lower Extremity Functional Scale   [ Time Frame: 4, 6, 12 weeks ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

5.  Secondary:   Maximal Knee Extensor Force During Concentric and Isometric Contractions   [ Time Frame: 4, 6, 12 weeks ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

6.  Secondary:   Knee Extensor Fatigue   [ Time Frame: 4, 6, 12 weeks ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

7.  Secondary:   Muscle Activation During Maximal Contractions and Fatigue Contractions   [ Time Frame: 4, 6, 12 weeks ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


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 due to small number of subjects. No statistical analysis of data due to small number of subjects.  


Results Point of Contact:  
Name/Title: Dr. Sheryl Finucane
Organization: Virginia Commonwealth University
phone: 804-628-3639
e-mail: sfinucan@vcu.edu


Publications:
Singer BJ, Silbert PL, Dunne JW, Song S, Singer KP. An open label pilot investigation of the efficacy of Botulinum toxin type A [Dysport] injection in the rehabilitation of chronic anterior knee pain. Disabil Rehabil. 2006 Jun 15;28(11):707-13.
Crossley K, Bennell K, Green S, McConnell J. A systematic review of physical interventions for patellofemoral pain syndrome. Clin J Sport Med. 2001 Apr;11(2):103-10. Review.
Crossley KM, Bennell KL, Cowan SM, Green S. Analysis of outcome measures for persons with patellofemoral pain: which are reliable and valid? Arch Phys Med Rehabil. 2004 May;85(5):815-22.


Responsible Party: Sheryl Finucane, Assistant Professor, Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT00496964     History of Changes
Other Study ID Numbers: PT_PMR_3700
Study First Received: July 5, 2007
Results First Received: March 14, 2011
Last Updated: April 22, 2011
Health Authority: United States: Institutional Review Board





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