Trial Outcomes & Findings for Botox for Non-surgical Lateral Release in Patellofemoral Pain (NCT NCT00496964)

Results Overview

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)

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

5 participants

Primary outcome timeframe

4, 6, 12 weeks

Results posted on

2017-10-23

Participant Flow

Participant milestones

Participant milestones
Measure	Botulinum Toxin A Injection + Exercise Injection of Botulinum toxin A into vastus lateralis of study limb plus exercise program	Placebo Injection + Exercise Placebo injection into Vastus Lateralis + exercise
Overall Study STARTED	1	4
Overall Study COMPLETED	1	3
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Botulinum Toxin A Injection + Exercise Injection of Botulinum toxin A into vastus lateralis of study limb plus exercise program	Placebo Injection + Exercise Placebo injection into Vastus Lateralis + exercise
Overall Study Withdrawal by Subject	0	1

Baseline Characteristics

Botox for Non-surgical Lateral Release in Patellofemoral Pain

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Botulinum Toxin A Injection + Exercise n=1 Participants Injection of Botulinum toxin A into vastus lateralis of study limb plus exercise program	Placebo Injection + Exercise n=4 Participants Placebo injection into Vastus Lateralis + exercise	Total n=5 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=5 Participants	4 Participants n=7 Participants	5 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	33 years n=5 Participants	25.5 years STANDARD_DEVIATION 2.53 • n=7 Participants	27.0 years STANDARD_DEVIATION 2.47 • n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	4 Participants n=7 Participants	5 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	1 participants n=5 Participants	4 participants n=7 Participants	5 participants n=5 Participants

PRIMARY outcome

Timeframe: 4, 6, 12 weeks

Population: analysis per protocol. Drop out not included in analysis. mean reduction in Visual Analog Scale for Pain (VAS) from start to 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)

Outcome measures

Outcome measures
Measure	Botulinum Toxin A Injection + Exercise n=1 Participants Injection of Botulinum toxin A into vastus lateralis of study limb plus exercise program	Placebo Injection + Exercise n=3 Participants Placebo injection into Vastus Lateralis + exercise
Visual Analog Scale Pain Ratings (VAS)	6 cm	3.7 cm Standard Deviation 0.33

PRIMARY outcome

Timeframe: 4, 6, 12 weeks

Population: 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.

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

Outcome measures

Outcome measures
Measure	Botulinum Toxin A Injection + Exercise n=1 Participants Injection of Botulinum toxin A into vastus lateralis of study limb plus exercise program	Placebo Injection + Exercise n=3 Participants Placebo injection into Vastus Lateralis + exercise
Change in Anterior Knee Pain Scale.	19 Units on Scale	16.7 Units on Scale Standard Deviation 4.37

PRIMARY outcome

Timeframe: 4, 6, 12 weeks

Population: No statistical analysis due to small number of subjects

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

Outcome measures

Outcome measures
Measure	Botulinum Toxin A Injection + Exercise n=1 Participants Injection of Botulinum toxin A into vastus lateralis of study limb plus exercise program	Placebo Injection + Exercise n=3 Participants Placebo injection into Vastus Lateralis + exercise
Functional Index Questionnaire Pre	11 units on a scale Standard Deviation NA only one subject	10 units on a scale Standard Deviation 1.7
Functional Index Questionnaire Post 4 wk	12 units on a scale Standard Deviation NA only one subject	10 units on a scale Standard Deviation 1.7
Functional Index Questionnaire Post 6 wk	11 units on a scale Standard Deviation NA only one subject	10.7 units on a scale Standard Deviation 0.6
Functional Index Questionnaire Post 12 wk	13 units on a scale Standard Deviation NA only one subject	14 units on a scale Standard Deviation 1.7

PRIMARY outcome

Timeframe: 4, 6, 12 weeks

Population: No statistical analysis due to small number of subjects

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.

Outcome measures

Outcome measures
Measure	Botulinum Toxin A Injection + Exercise n=1 Participants Injection of Botulinum toxin A into vastus lateralis of study limb plus exercise program	Placebo Injection + Exercise n=3 Participants Placebo injection into Vastus Lateralis + exercise
Lower Extremity Functional Scale Pre	69 percentage of total possible score Standard Deviation NA only one subject	66.7 percentage of total possible score Standard Deviation 14.6
Lower Extremity Functional Scale Post 4 wks	87 percentage of total possible score Standard Deviation NA only one subject	71 percentage of total possible score Standard Deviation 8
Lower Extremity Functional Scale Post 6 wks	87 percentage of total possible score Standard Deviation NA only one subject	73 percentage of total possible score Standard Deviation 11.4
Lower Extremity Functional Scale Post 12 wks	91 percentage of total possible score Standard Deviation NA only one subject	75 percentage of total possible score Standard Deviation 14

SECONDARY outcome

Timeframe: 4, 6, 12 weeks

Outcome measures

Outcome measures
Measure	Botulinum Toxin A Injection + Exercise n=1 Participants Injection of Botulinum toxin A into vastus lateralis of study limb plus exercise program	Placebo Injection + Exercise n=3 Participants Placebo injection into Vastus Lateralis + exercise
Maximal Knee Extensor Force During Concentric and Isometric Contractions Isometric Torque 30deg pre	26 Nm Standard Deviation NA only one subject	31.3 Nm Standard Deviation 13.1
Maximal Knee Extensor Force During Concentric and Isometric Contractions Isometric Torque 30deg 4w	57 Nm Standard Deviation NA only one subject	43.7 Nm Standard Deviation 8.1
Maximal Knee Extensor Force During Concentric and Isometric Contractions Isometric Torque 30deg 6w	43 Nm Standard Deviation NA only one subject	39.0 Nm Standard Deviation 2.65
Maximal Knee Extensor Force During Concentric and Isometric Contractions Isometric Torque 30deg 12w	37 Nm Standard Deviation NA only one subject	42.3 Nm Standard Deviation 5.1

SECONDARY outcome

Timeframe: 4, 6, 12 weeks

Population: This is not available due to data collection errors

This is not available due to data collection errors

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 4, 6, 12 weeks

muscle activation as EMG ratios of VMO/VL at 30 degrees maximal isometric contraction at 30degrees

Outcome measures

Outcome measures
Measure	Botulinum Toxin A Injection + Exercise n=1 Participants Injection of Botulinum toxin A into vastus lateralis of study limb plus exercise program	Placebo Injection + Exercise n=3 Participants Placebo injection into Vastus Lateralis + exercise
Muscle Activation During Maximal Contractions and Fatigue Contractions EMG ratio VMO/VL pre	0.91 ratio VMO EMG to VL EMG Standard Deviation NA Only one subject	0.6 ratio VMO EMG to VL EMG Standard Deviation 0.14
Muscle Activation During Maximal Contractions and Fatigue Contractions EMG ratio VMO/VL 4wk	NA ratio VMO EMG to VL EMG Standard Deviation NA Equipment error during data collection session resulted in invalid data	0.61 ratio VMO EMG to VL EMG Standard Deviation 0.35
Muscle Activation During Maximal Contractions and Fatigue Contractions EMG ratio VMO/VL 6wk	0.54 ratio VMO EMG to VL EMG Standard Deviation NA Only one subject	0.50 ratio VMO EMG to VL EMG Standard Deviation 0.15
Muscle Activation During Maximal Contractions and Fatigue Contractions EMG ratio VMO/VL 12wk	0.55 ratio VMO EMG to VL EMG Standard Deviation NA Only one subject	0.69 ratio VMO EMG to VL EMG Standard Deviation 0.33

Adverse Events

Botulinum Toxin A Injection + Exercise

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo Injection + Exercise

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Sheryl Finucane

Virginia Commonwealth University

Phone: 804-628-3639

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place