Trial · NCT00496964
Botox for Non-surgical Lateral Release in Patellofemoral Pain
NCT00496964, Phase 3, Terminated, Virginia Commonwealth University; results first posted 2011-05-18
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Botox for Non-surgical Lateral Release in Patellofemoral Pain. Trials, record NCT00496964. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00496964
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Botox for Non-surgical Lateral Release in Patellofemoral Pain
- NCT number
- NCT00496964
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 5 participants, actual
- Lead sponsor
- Virginia Commonwealth University
- Conditions
- Patellofemoral Pain Syndrome
- Interventions
- Botulinum toxin A + exercise, Placebo
- First posted
- 2007-07-06
- Last updated
- 2017-10-23
- Results first posted
- 2011-05-18
- Limitations and caveats
- Early termination due to small number of subjects. No statistical analysis of data due to small number of subjects.
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Visual Analog Scale Pain Ratings (VAS) | 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) |
| Primary | Change in Anterior Knee Pain Scale. | 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 |
| Primary | Functional Index Questionnaire | 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 |
| Primary | Lower Extremity Functional Scale | 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. |
| Secondary | Maximal Knee Extensor Force During Concentric and Isometric Contractions | 4, 6, 12 weeks | |
| Secondary | Knee Extensor Fatigue | 4, 6, 12 weeks | This is not available due to data collection errors |
| Secondary | Muscle Activation During Maximal Contractions and Fatigue Contractions | 4, 6, 12 weeks | muscle activation as EMG ratios of VMO/VL at 30 degrees maximal isometric contraction at 30degrees |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Visual Analog Scale Pain Ratings (VAS) | 4, 6, 12 weeks | analysis per protocol. Drop out not included in analysis. mean reduction in Visual Analog Scale for Pain (VAS) from start to 12 weeks. | cm | MEAN |
| PRIMARY | Change in Anterior Knee Pain Scale. | 4, 6, 12 weeks | 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. | Units on Scale | MEAN |
| PRIMARY | Functional Index Questionnaire | 4, 6, 12 weeks | No statistical analysis due to small number of subjects | units on a scale | MEAN |
| PRIMARY | Lower Extremity Functional Scale | 4, 6, 12 weeks | No statistical analysis due to small number of subjects | percentage of total possible score | MEAN |
| SECONDARY | Maximal Knee Extensor Force During Concentric and Isometric Contractions | 4, 6, 12 weeks | Nm | MEAN | |
| SECONDARY | Knee Extensor Fatigue | 4, 6, 12 weeks | This is not available due to data collection errors | ||
| SECONDARY | Muscle Activation During Maximal Contractions and Fatigue Contractions | 4, 6, 12 weeks | ratio VMO EMG to VL EMG | MEAN |
Source ClinicalTrials.gov
Results by group36
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Visual Analog Scale Pain Ratings (VAS) | Botulinum Toxin A Injection + Exercise | 6 | cm | ||
| Visual Analog Scale Pain Ratings (VAS) | Placebo Injection + Exercise | 3.7 | Standard Deviation 0.33 | cm | |
| Change in Anterior Knee Pain Scale. | Botulinum Toxin A Injection + Exercise | 19 | Units on Scale | ||
| Change in Anterior Knee Pain Scale. | Placebo Injection + Exercise | 16.7 | Standard Deviation 4.37 | Units on Scale | |
| Functional Index Questionnaire | Botulinum Toxin A Injection + Exercise | Pre | 11 | Standard Deviation NA | units on a scale |
| Functional Index Questionnaire | Placebo Injection + Exercise | Pre | 10 | Standard Deviation 1.7 | units on a scale |
| Functional Index Questionnaire | Botulinum Toxin A Injection + Exercise | Post 4 wk | 12 | Standard Deviation NA | units on a scale |
| Functional Index Questionnaire | Placebo Injection + Exercise | Post 4 wk | 10 | Standard Deviation 1.7 | units on a scale |
| Functional Index Questionnaire | Botulinum Toxin A Injection + Exercise | Post 6 wk | 11 | Standard Deviation NA | units on a scale |
| Functional Index Questionnaire | Placebo Injection + Exercise | Post 6 wk | 10.7 | Standard Deviation 0.6 | units on a scale |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Botulinum Toxin A Injection + Exercise | 1 | |
| Overall Study | STARTED | Placebo Injection + Exercise | 4 | |
| Overall Study | COMPLETED | Botulinum Toxin A Injection + Exercise | 1 | |
| Overall Study | COMPLETED | Placebo Injection + Exercise | 3 | |
| Overall Study | NOT COMPLETED | Botulinum Toxin A Injection + Exercise | 0 | |
| Overall Study | NOT COMPLETED | Placebo Injection + Exercise | 1 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Botulinum Toxin A Injection + Exercise | ||
| Total, all-cause mortality | Placebo Injection + Exercise | ||
| Total, other adverse events | Botulinum Toxin A Injection + Exercise | 0 | 1 |
| Total, other adverse events | Placebo Injection + Exercise | 0 | 4 |
| Total, serious adverse events | Botulinum Toxin A Injection + Exercise | 0 | 1 |
| Total, serious adverse events | Placebo Injection + Exercise | 0 | 4 |
Source ClinicalTrials.gov
Papers3
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Botulinum Toxin A Injection + Exercise vs Placebo Injection + Exercise: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00496964
GET https://conductscience.org/api/trials/v1/NCT00496964/results?page=2