Trial Outcomes & Findings for Comparing Rehabilitation Programs for Patellofemoral Pain Syndrome (NCT NCT00445224)
NCT ID: NCT00445224
Last Updated: 2017-03-28
Results Overview
0 to 10 cm line with 0 representing no pain and 10 representing severe pain
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
33 participants
Primary outcome timeframe
weekly
Results posted on
2017-03-28
Participant Flow
33 females with anterior knee pain (PFPS) volunteered to participate in this study. Enrollment began August 2007 and last subject was enrolled in August 2009.
Subjects were evaluated for PFPS using the following:(1)anterior knee pain reported during at least 2 activities: stair climbing, running, squatting, kneeling, and prolonged sitting;(2)insidious onset of symptoms ;(3)pain with compression of the patella; and(4)pain on palpation of patellar facets. Only three patients were excluded during study.
Participant milestones
| Measure |
Hip Strengthening Then Combined Exercises
Performed hip strengthening exercises for 4 weeks prior to crossing over to a combined hip and quadricep rehabilitation program
|
Quadricep Group Then Combined Exercises
Performed quadricep strengthening exercises for 4 weeks prior to crossing over to a combined hip and quadricep rehabilitation program
|
|---|---|---|
|
Specific Exercises
STARTED
|
17
|
16
|
|
Specific Exercises
Baseline
|
17
|
16
|
|
Specific Exercises
4 Weeks
|
14
|
13
|
|
Specific Exercises
COMPLETED
|
13
|
13
|
|
Specific Exercises
NOT COMPLETED
|
4
|
3
|
|
Combined Exercises
STARTED
|
13
|
13
|
|
Combined Exercises
COMPLETED
|
13
|
13
|
|
Combined Exercises
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
Hip Strengthening Then Combined Exercises
Performed hip strengthening exercises for 4 weeks prior to crossing over to a combined hip and quadricep rehabilitation program
|
Quadricep Group Then Combined Exercises
Performed quadricep strengthening exercises for 4 weeks prior to crossing over to a combined hip and quadricep rehabilitation program
|
|---|---|---|
|
Specific Exercises
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
Comparing Rehabilitation Programs for Patellofemoral Pain Syndrome
Baseline characteristics by cohort
| Measure |
Hip Strengthening Then Combined Exercises
n=17 Participants
Performed hip strengthening exercises for 4 weeks prior to crossing over to a combined hip and quadricep rehabilitation program
|
Quadricep Group Then Combined Exercises
n=16 Participants
Performed quadricep strengthening exercises for 4 weeks prior to crossing over to a combined hip and quadricep rehabilitation program
|
Total
n=33 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
17 Participants
n=93 Participants
|
16 Participants
n=4 Participants
|
33 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Continuous
|
24.6 years
STANDARD_DEVIATION 5.3 • n=93 Participants
|
25.7 years
STANDARD_DEVIATION 5.9 • n=4 Participants
|
25 years
STANDARD_DEVIATION 5.5 • n=27 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=93 Participants
|
16 Participants
n=4 Participants
|
33 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
17 participants
n=93 Participants
|
16 participants
n=4 Participants
|
33 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: weekly0 to 10 cm line with 0 representing no pain and 10 representing severe pain
Outcome measures
| Measure |
Hip Strengthening Then Combined Exercises
n=17 Participants
Performed hip strengthening exercises for 4 weeks prior to crossing over to a combined hip and quadricep rehabilitation program
|
Quadricep Group Then Combined Exercises
n=16 Participants
Performed quadricep strengthening exercises for 4 weeks prior to crossing over to a combined hip and quadricep rehabilitation program
|
|---|---|---|
|
Visual Analog Pain Scale (Describing Worst Pain Felt During the Past Week)
|
4.5 centimeter
Standard Deviation 2.5
|
4.2 centimeter
Standard Deviation 2.2
|
PRIMARY outcome
Timeframe: Baseline, Mid-Intervention, and Post-InterventionOutcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 8 weekVisual analog pain scale at end of intervention. 0 to 10 cm line with 0 representing no pain and 10 representing severe pain
Outcome measures
| Measure |
Hip Strengthening Then Combined Exercises
n=17 Participants
Performed hip strengthening exercises for 4 weeks prior to crossing over to a combined hip and quadricep rehabilitation program
|
Quadricep Group Then Combined Exercises
n=16 Participants
Performed quadricep strengthening exercises for 4 weeks prior to crossing over to a combined hip and quadricep rehabilitation program
|
|---|---|---|
|
Visual Analog Pain Scale
|
2.4 centimeters
Standard Deviation 2.8
|
2.6 centimeters
Standard Deviation 2.0
|
SECONDARY outcome
Timeframe: Baseline, Mid, and Post-InterventionOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Mid and Post-InterventionOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Mid, and Post-InterventionOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 8 weekSide lying Hip Abduction maximal muscular contraction with a hand held dynamometer
Outcome measures
| Measure |
Hip Strengthening Then Combined Exercises
n=17 Participants
Performed hip strengthening exercises for 4 weeks prior to crossing over to a combined hip and quadricep rehabilitation program
|
Quadricep Group Then Combined Exercises
n=16 Participants
Performed quadricep strengthening exercises for 4 weeks prior to crossing over to a combined hip and quadricep rehabilitation program
|
|---|---|---|
|
Hip Abduction Strength
|
6.6 (Newton*meters)/(Weight*Height)
Standard Deviation .9
|
6.2 (Newton*meters)/(Weight*Height)
Standard Deviation 1.8
|
Adverse Events
Hip Strengthening Then Combined Exercises
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Quadricep Group Then Combined Exercises
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. Tim L. Uhl Principal Investigator
University of Kentucky
Phone: 859-323-1100
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place