Ignite Creation Date:
2024-05-05 @ 6:32 PM
Last Modification Date:
2024-10-26 @ 9:34 AM
Study NCT ID:
NCT00496964
Status:
TERMINATED
Last Update Posted:
2017-10-23
First Post:
2007-07-05
Brief Title:
Botox for Non-surgical Lateral Release in Patellofemoral Pain
Sponsor:
Virginia Commonwealth University
Organization:
Virginia Commonwealth University
Study Overview
Official Title:
Botox for Non-surgical Lateral Release in Patellofemoral Pain
Status:
TERMINATED
Status Verified Date:
2017-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Insufficient recruitment in a reasonable time expiration of study medication
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to determine whether the use of botulinum toxin A injected into the lateral thigh muscle improves knee function and reduces knee pain secondary to patellofemoral syndrome The study hypothesis is that botulinum toxin specific exercises will be superior to specific exercises alone in improving knee function and reducing knee pain in individuals with patellofemoral syndrome
Detailed Description:
Patellofemoral pain syndrome is a leading cause of knee pain in persons under 45 and is particularly common in women The prevailing theory for the etiology of patellofemoral pain is an imbalance in force or timing of the pull of the knee extensor muscles on the patella resulting in improper tracking of the patella in the femoral grove Specifically the vastus medialis is thought to be ineffective in overcoming the lateral pull of the vastus lateralis When exercises designed to focus on improving strength and timing of activation of the vastus medialis fail surgical release of part of the attachment of the vastus lateralis to the patella is considered
Botulinum toxin temporarily blocks acetylcholine release from motor neurons and is used clinically to produce muscle relaxation
Subjects with patellofemoral syndrome will be recruited into the study Half of the subjects will be given a placebo injection while the other half will be given an injection of Botox Botulinum Toxin A Allergen into the vastus lateralis muscle Group assignment will be randomized and a double blind protocol used Prior to injection the subject will record their level of knee pain fill out several knee function questionnaires and have the strength and endurance of their knee extensor muscles tested All subjects will be given an exercise program designed to target strengthening of the medial thigh muscles as well as stretching of lateral structures
At 4 6 and 12 weeks knee pain and knee function will again be assessed
Botulinum toxin temporarily blocks acetylcholine release from motor neurons and is used clinically to produce muscle relaxation
Subjects with patellofemoral syndrome will be recruited into the study Half of the subjects will be given a placebo injection while the other half will be given an injection of Botox Botulinum Toxin A Allergen into the vastus lateralis muscle Group assignment will be randomized and a double blind protocol used Prior to injection the subject will record their level of knee pain fill out several knee function questionnaires and have the strength and endurance of their knee extensor muscles tested All subjects will be given an exercise program designed to target strengthening of the medial thigh muscles as well as stretching of lateral structures
At 4 6 and 12 weeks knee pain and knee function will again be assessed
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None