Botox for Non-surgical Lateral Release in Patellofemoral Pain
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00496964|
Recruitment Status : Terminated (Insufficient recruitment in a reasonable time + expiration of study medication)
First Posted : July 6, 2007
Results First Posted : May 18, 2011
Last Update Posted : October 23, 2017
|Condition or disease||Intervention/treatment||Phase|
|Patellofemoral Pain Syndrome||Drug: Botulinum toxin A + exercise Drug: Placebo||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||5 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||Botox for Non-surgical Lateral Release in Patellofemoral Pain|
|Study Start Date :||May 2005|
|Actual Primary Completion Date :||June 2008|
|Actual Study Completion Date :||June 2008|
Injection of Botulinum toxin A into vastus lateralis of study limb plus exercise program
Drug: Botulinum toxin A + exercise
Injection of 100 units Botox (Botulinum toxin type A) into the Vastus Lateralis of the study leg + 12 weeks of exercise for patellofemoral pain
Other Name: Botox
Placebo Comparator: 2
Placebo injection + exercise
Injection of 2 cc placebo containing 0.1cc sodium bicarbonate 8.4% (1meq/cc), 0.9cc normal saline and 1 cc of lidocaine into the vastus lateralis of the study leg followed by 12 weeks of exercise for patellofemoral pain syndrome
- Visual Analog Scale Pain Ratings (VAS) [ Time Frame: 4, 6, 12 weeks ]Visual Analog Scale pain rating (VAS). 10 cm line with anchors at 0 (no pain) and 10 cm (worst imaginable pain). Scores are in cm (0 - 10) 0 no pain, higher values greater pain. Results given are for change at 12 weeks compared to baseline (week 12 score - baseline score)
- Change in Anterior Knee Pain Scale. [ Time Frame: 4, 6, 12 weeks ]
Anterior Knee Pain Scale: a 13-item questionnaire; a TOTAL score of 0 = severe disability; a score of 100 = no pain or disability. (items are scored 0-5 or 0-10).
Change scores at 12 wks are reported. Inverted so positive values reflect improvement.
Included items: difficulty with: weight bearing, walking, stairs, squat, run, jump, prolonged sitting; presence of limp, swelling, patellar subluxation, atrophy of thigh, reduced knee flexion. Reference: Kujala et al: Scoring of Patellofemoral Disorders. J Arthroscopic Rel Surg, 9(2)159-163, 1993
- Functional Index Questionnaire [ Time Frame: 4, 6, 12 weeks ]The Functional Index Questionnaire (FIQ) is a self report functional rating scale. Individuals rate eight-activities. Each activity is rated from 0 - 2 with ) being unable to perform the activity and 2 being able to perform the activity without difficulty. The total score is summed for a final score of 0 - 16. 0 indicates that the individual is ubable to perform any of the tasks, 16 indicates that the subject is able to perform all tasks without difficulty. The eight items include: walking (1 block and 1 mile), climbing stairs (2 flights and 4 flights), squatting, kneeling, prolonged sitting, and running
- Lower Extremity Functional Scale [ Time Frame: 4, 6, 12 weeks ]The lower extremity functional scale (LEFS) is a self report questionnaire. Subjects rate 19 items related to general activities that require the lower extremities on a scale of 0 - 4. 0 = extreme difficulty or unable to perform the activity, 4 = No difficulty performing the activity. The total of all rankings are summed and divided by the maximum score (76). The score is reported as a percentage. 100% = no difficulty in performing any of the tasks. 0% = extreme difficulty or unable to perform all of the tasks.
- Maximal Knee Extensor Force During Concentric and Isometric Contractions [ Time Frame: 4, 6, 12 weeks ]
- Knee Extensor Fatigue [ Time Frame: 4, 6, 12 weeks ]This is not available due to data collection errors
- Muscle Activation During Maximal Contractions and Fatigue Contractions [ Time Frame: 4, 6, 12 weeks ]muscle activation as EMG ratios of VMO/VL at 30 degrees maximal isometric contraction at 30degrees
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00496964
|United States, Virginia|
|Virginia Commonwealth University|
|Richmond, Virginia, United States, 23298|
|Principal Investigator:||Sheryl D Finucane, PhD, PT||Department of Physical Therapy, Virginia Commonwealth University|