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Insufficient recruitment in a reasonable time + expiration of study medication
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| Name | Class |
|---|---|
| Allergan | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Injection of Botulinum toxin A into vastus lateralis of study limb plus exercise program |
|
| 2 | Placebo Comparator | Placebo injection + exercise |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Botulinum toxin A + exercise | Drug | Injection of 100 units Botox (Botulinum toxin type A) into the Vastus Lateralis of the study leg + 12 weeks of exercise for patellofemoral pain |
| Measure | Description | Time Frame |
|---|---|---|
| Visual Analog Scale Pain Ratings (VAS) | 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) | 4, 6, 12 weeks |
| Change in Anterior Knee Pain Scale. | 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 | 4, 6, 12 weeks |
| Functional Index Questionnaire | 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 | 4, 6, 12 weeks |
| Lower Extremity Functional Scale | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Maximal Knee Extensor Force During Concentric and Isometric Contractions | 4, 6, 12 weeks | |
| Knee Extensor Fatigue | This is not available due to data collection errors | 4, 6, 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sheryl D Finucane, PhD, PT | Department of Physical Therapy, Virginia Commonwealth University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Virginia Commonwealth University | Richmond | Virginia | 23298 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16809213 | Background | 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. doi: 10.1080/09638280500301477. | |
| 11403109 | Background | 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. doi: 10.1097/00042752-200104000-00007. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Botulinum Toxin A Injection + Exercise | Injection of Botulinum toxin A into vastus lateralis of study limb plus exercise program |
| FG001 | Placebo Injection + Exercise | Placebo injection into Vastus Lateralis + exercise |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Botulinum Toxin A Injection + Exercise | Injection of Botulinum toxin A into vastus lateralis of study limb plus exercise program |
| BG001 | Placebo Injection + Exercise | Placebo injection into Vastus Lateralis + exercise |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Visual Analog Scale Pain Ratings (VAS) | 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) | analysis per protocol. Drop out not included in analysis. mean reduction in Visual Analog Scale for Pain (VAS) from start to 12 weeks. | Posted | Mean | Standard Deviation | cm | 4, 6, 12 weeks |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Botulinum Toxin A Injection + Exercise | Injection of Botulinum toxin A into vastus lateralis of study limb plus exercise program |
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Early termination due to small number of subjects. No statistical analysis of data due to small number of subjects.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Sheryl Finucane | Virginia Commonwealth University | 804-628-3639 | sfinucan@vcu.edu |
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| ID | Term |
|---|---|
| D046788 | Patellofemoral Pain Syndrome |
| D007718 | Knee Injuries |
| ID | Term |
|---|---|
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D007869 | Leg Injuries |
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| D019274 | Botulinum Toxins, Type A |
| D015444 | Exercise |
| ID | Term |
|---|---|
| D001905 | Botulinum Toxins |
| D008666 | Metalloendopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
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|
| Placebo | Drug | 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 |
|
| 4, 6, 12 weeks |
| Muscle Activation During Maximal Contractions and Fatigue Contractions | muscle activation as EMG ratios of VMO/VL at 30 degrees maximal isometric contraction at 30degrees | 4, 6, 12 weeks |
| 15129407 | Background | 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. doi: 10.1016/s0003-9993(03)00613-0. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Placebo injection into Vastus Lateralis + exercise
|
|
| Primary | Change in Anterior Knee Pain Scale. | 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 | The Anterior Knee Pain Scale is a 13-item questionnaire; a score of 0 = severe disability; a score of 100 = no pain or disability. Change scores are reported. Positive values = improvement in symptoms. | Posted | Mean | Standard Deviation | Units on Scale | 4, 6, 12 weeks |
|
|
|
| Primary | Functional Index Questionnaire | 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 | No statistical analysis due to small number of subjects | Posted | Mean | Standard Deviation | units on a scale | 4, 6, 12 weeks |
|
|
|
| Primary | Lower Extremity Functional Scale | 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. | No statistical analysis due to small number of subjects | Posted | Mean | Standard Deviation | percentage of total possible score | 4, 6, 12 weeks |
|
|
|
| Secondary | Maximal Knee Extensor Force During Concentric and Isometric Contractions | Posted | Mean | Standard Deviation | Nm | 4, 6, 12 weeks |
|
|
|
| Secondary | Knee Extensor Fatigue | This is not available due to data collection errors | This is not available due to data collection errors | Posted | 4, 6, 12 weeks |
|
|
| Secondary | Muscle Activation During Maximal Contractions and Fatigue Contractions | muscle activation as EMG ratios of VMO/VL at 30 degrees maximal isometric contraction at 30degrees | Posted | Mean | Standard Deviation | ratio VMO EMG to VL EMG | 4, 6, 12 weeks |
|
|
|
| 0 |
| 1 |
| 0 |
| 1 |
| EG001 | Placebo Injection + Exercise | Placebo injection into Vastus Lateralis + exercise | 0 | 4 | 0 | 4 |
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| D006867 |
| Hydrolases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D045726 | Metalloproteases |
| D001426 | Bacterial Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D001427 | Bacterial Toxins |
| D014118 | Toxins, Biological |
| D001685 | Biological Factors |
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
| Post 6 wk |
|
| Post 12 wk |
|
| Post 6 wks |
|
| Post 12 wks |
|
| Isometric Torque 30deg 6w |
|
| Isometric Torque 30deg 12w |
|
| EMG ratio VMO/VL 6wk |
|
| EMG ratio VMO/VL 12wk |
|