A Phase 3 interventional study of Botulinum toxin A + exercise and Placebo in Patellofemoral Pain Syndrome, sponsored by Virginia Commonwealth University. Terminated at 1 site in United States. Open to participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2017-10-23.
Sponsored by Virginia Commonwealth University · Phase 3, Interventional, and Treatment
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.
295 studies on the registry are indexed under Patellofemoral Pain Syndrome; 75 are open to participants now.
This study's enrollment of 5 is below the median of 45 across 242 interventional studies indexed under Patellofemoral Pain Syndrome.
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Of its 88 completed or terminated interventional studies of FDA-regulated products, 62 (70%) have results posted.
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Exclusion Criteria:
Injection of Botulinum toxin A into vastus lateralis of study limb plus exercise program
Drug: Botulinum toxin A + exercise
Placebo injection + exercise
Drug: Placebo
Injection of 100 units Botox (Botulinum toxin type A) into the Vastus Lateralis of the study leg + 12 weeks of exercise for patellofemoral pain
Also known as: Botox
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)
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)
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 4, 6, 12 weeks
Maximal Knee Extensor Force During Concentric and Isometric Contractions
Time frame: 4, 6, 12 weeks
Knee Extensor Fatigue
This is not available due to data collection errors
Time frame: 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
Time frame: 4, 6, 12 weeks
| Milestone | Botulinum Toxin A Injection + Exercise | Placebo Injection + Exercise |
|---|---|---|
| Started | 1 | 4 |
| Completed | 1 | 3 |
| Not completed | 0 | 1 |
| Withdrew: Withdrawal by subject | 0 | 1 |
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)
| cm | Botulinum Toxin A Injection + Exercise | Placebo Injection + Exercise |
|---|---|---|
| Visual Analog Scale Pain Ratings (VAS) | 6 | 3.7 ± 0.33 |
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
| Units on Scale | Botulinum Toxin A Injection + Exercise | Placebo Injection + Exercise |
|---|---|---|
| Change in Anterior Knee Pain Scale. | 19 | 16.7 ± 4.37 |
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
| units on a scale | Botulinum Toxin A Injection + Exercise | Placebo Injection + Exercise |
|---|---|---|
| Pre | 11 ± NA | 10 ± 1.7 |
| Post 4 wk | 12 ± NA | 10 ± 1.7 |
| Post 6 wk | 11 ± NA | 10.7 ± 0.6 |
| Post 12 wk | 13 ± NA | 14 ± 1.7 |
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.
| percentage of total possible score | Botulinum Toxin A Injection + Exercise | Placebo Injection + Exercise |
|---|---|---|
| Pre | 69 ± NA | 66.7 ± 14.6 |
| Post 4 wks | 87 ± NA | 71 ± 8 |
| Post 6 wks | 87 ± NA | 73 ± 11.4 |
| Post 12 wks | 91 ± NA | 75 ± 14 |
| Nm | Botulinum Toxin A Injection + Exercise | Placebo Injection + Exercise |
|---|---|---|
| Isometric Torque 30deg pre | 26 ± NA | 31.3 ± 13.1 |
| Isometric Torque 30deg 4w | 57 ± NA | 43.7 ± 8.1 |
| Isometric Torque 30deg 6w | 43 ± NA | 39.0 ± 2.65 |
| Isometric Torque 30deg 12w | 37 ± NA | 42.3 ± 5.1 |
This is not available due to data collection errors
No measurements were reported for this outcome.
muscle activation as EMG ratios of VMO/VL at 30 degrees maximal isometric contraction at 30degrees
| ratio VMO EMG to VL EMG | Botulinum Toxin A Injection + Exercise | Placebo Injection + Exercise |
|---|---|---|
| EMG ratio VMO/VL pre | 0.91 ± NA | 0.6 ± 0.14 |
| EMG ratio VMO/VL 4wk | NA ± NA | 0.61 ± 0.35 |
| EMG ratio VMO/VL 6wk | 0.54 ± NA | 0.50 ± 0.15 |
| EMG ratio VMO/VL 12wk | 0.55 ± NA | 0.69 ± 0.33 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Botulinum Toxin A Injection + Exercise | — | 0/1 (0%) | 0/1 (0%) |
| Placebo Injection + Exercise | — | 0/4 (0%) | 0/4 (0%) |
| Age, Categorical(Participants) | Botulinum Toxin A Injection + Exercise | Placebo Injection + Exercise | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 1 | 4 | 5 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | Botulinum Toxin A Injection + Exercise | Placebo Injection + Exercise | Total |
|---|---|---|---|
| Mean | 33 | 25.5 ± 2.53 | 27.0 ± 2.47 |
| Sex: Female, Male(Participants) | Botulinum Toxin A Injection + Exercise | Placebo Injection + Exercise | Total |
|---|---|---|---|
| Female | 1 | 4 | 5 |
| Male | 0 | 0 | 0 |
| Region of Enrollment(participants) | Botulinum Toxin A Injection + Exercise | Placebo Injection + Exercise | Total |
|---|---|---|---|
| United States | 1 | 4 | 5 |
This study is terminated, as verified in Sep 2017. You cannot join it, but the record below documents what was studied.
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Virginia Commonwealth University