Comparing Rehabilitation Programs for Patellofemoral Pain Syndrome

• Sponsor: Timothy Uhl (Other)
• Overall Status: Completed
• CT.gov ID: NCT00445224
• Collaborator: (none)
• Enrollment: 33
• Location: 1
• Arms: 2
• Duration (Months): 24
• Patients Per Site Per Month: 1.4

Study Details

Study Description

Brief Summary

Patellofemoral pain syndrome (PFPS) is a common knee disorder affecting physically active people. Despite the growing base of support for the early introduction of hip strengthening exercises into the rehabilitation of PFPS, there have been few randomized clinical trials comparing isolated hip to isolated quadriceps strengthening. The purpose of this study is to determine how different exercises affect pain, strength, muscle activity, and function in female subjects with patellofemoral pain. The researchers hypothesize that females diagnosed with PFPS who initially participate in a hip strengthening program will report a greater perceived level of function, greater strength, less pain, and improved neuromuscular activity than those who participate in a progressive quadriceps strengthening intervention.

Condition or Disease	Intervention/Treatment	Phase
Patellofemoral Pain Syndrome	Other: Hip Progressive Resistive Exercise; Other: Quad Progressive Resistive Exercises	N/A

Detailed Description

Methods: Thirty-three females with PFPS will perform either initial hip strengthening (hip group) or initial quadriceps strengthening (quad group) for 4 weeks, prior to 4 weeks of a similar program of functional weight-bearing exercises. Self-reported pain, function, and functional strength were measured. Isometric strength was assessed for hip abductors, external rotators, and knee extensors. A mixed-model analysis of variance will be used to determine group differences over time.

Study Design

• Study Type: Interventional
• Actual Enrollment: 33 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Comparison of Early Hip Strengthening to Early Quadriceps Strengthening in the Treatment of Females With Patellofemoral Pain
• Study Start Date: Jan 1, 2008
• Actual Primary Completion Date: Jan 1, 2010
• Actual Study Completion Date: Jan 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Hip Progressive Resistive Exercises Exercises targeting hip musculature such as hip abduction and hip external rotation that was progressed by increased resistance following typical progressive resistive exercise approach.	Other: Hip Progressive Resistive Exercise; Hip Progressive Resistance Exercise program will be carried out by subjects under supervision once a week and then performed at home 2 additional times at home without supervision. Exercises focus on strengthening hip abduction ad external rotation musculature.
Active Comparator: Quad Progressive Resistive Exercises Exercises targeting quadriceps musculature such as quadriceps isometric setting, terminal knee extensions, and straight leg raises that was progressed by increased resistance following typical progressive resistive exercise approach..	Other: Quad Progressive Resistive Exercises; Quad Progressive Resistive Exercise program will be carried out by subjects under supervision once a week and then performed at home 2 additional times at home without supervision. Exercises focus on strengthening quadriceps musculature with straight leg raises and quadriceps isometrics.

Outcome Measures

Primary Outcome Measures

1. Visual Analog Pain Scale (Describing Worst Pain Felt During the Past Week) [weekly]

   0 to 10 cm line with 0 representing no pain and 10 representing severe pain

2. Subjective Function by Lower Extremity Functional Scale Report Form [Baseline, Mid-Intervention, and Post-Intervention]

3. Visual Analog Pain Scale [8 week]

   Visual analog pain scale at end of intervention. 0 to 10 cm line with 0 representing no pain and 10 representing severe pain

Secondary Outcome Measures

1. Strength by Isometric Dynamometer [Baseline, Mid, and Post-Intervention]

2. Neuromuscular Activity by Surface Electromyographical Amplitude During Stair Descent [Baseline, Mid and Post-Intervention]

3. Objective Function by Step-down Task for 30 Seconds [Baseline, Mid, and Post-Intervention]

4. Hip Abduction Strength [8 week]

   Side lying Hip Abduction maximal muscular contraction with a hand held dynamometer

Eligibility Criteria

Criteria

• Ages Eligible for Study: 15 Years to 35 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• anterior or retropatellar knee pain reported during at least 2 of the following activities: ascending and descending stairs, hopping and running, squatting, kneeling, and prolonged sitting

• insidious onset of symptoms not related to trauma

• pain with compression of the patella

• pain on palpation of the patellar facets

Exclusion Criteria:

• symptoms present for less than one month

• clinical evidence of other knee pathology

• history of recent knee surgery within past one year

• history of patellar dislocations or subluxations

• current significant injury affecting other lower extremity joints

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Kentucky	Lexington	Kentucky	United States	40506

Sponsors and Collaborators

• Timothy Uhl

Investigators

• Study Chair: Timothy Uhl, PhD, ATC, PT, University of Kentucky

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Timothy Uhl, Professor, University of Kentucky
• ClinicalTrials.gov Identifier: NCT00445224
• Other Study ID Numbers: 07-0138-F2L
• First Posted: Mar 8, 2007
• Last Update Posted: Mar 28, 2017
• Last Verified: Feb 1, 2017

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Keywords provided by Timothy Uhl, Professor, University of Kentucky: Knee pain; Rehabilitation
• Additional relevant MeSH terms: Patellofemoral Pain Syndrome; Syndrome

Study Results

Participant Flow

Recruitment Details	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.
Pre-assignment Detail	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.

Arm/Group Title	Hip Strengthening Then Combined Exercises	Quadricep Group Then Combined Exercises
Arm/Group Description	Performed hip strengthening exercises for 4 weeks prior to crossing over to a combined hip and quadricep rehabilitation program	Performed quadricep strengthening exercises for 4 weeks prior to crossing over to a combined hip and quadricep rehabilitation program
Period Title: Specific Exercises
STARTED	17	16
Baseline	17	16
4 Weeks	14	13
COMPLETED	13	13
NOT COMPLETED	4	3
Period Title: Specific Exercises
STARTED	13	13
COMPLETED	13	13
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Hip Strengthening Then Combined Exercises	Quadricep Group Then Combined Exercises	Total
Arm/Group Description	Performed hip strengthening exercises for 4 weeks prior to crossing over to a combined hip and quadricep rehabilitation program	Performed quadricep strengthening exercises for 4 weeks prior to crossing over to a combined hip and quadricep rehabilitation program	Total of all reporting groups
Overall Participants	17	16	33
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	17 100%	16 100%	33 100%
>=65 years	0 0%	0 0%	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	24.6 (5.3)	25.7 (5.9)	25 (5.5)
Sex: Female, Male (Count of Participants)
Female	17 100%	16 100%	33 100%
Male	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
United States	17 100%	16 100%	33 100%

Outcome Measures

1. Primary Outcome

Title	Visual Analog Pain Scale (Describing Worst Pain Felt During the Past Week)
Description	0 to 10 cm line with 0 representing no pain and 10 representing severe pain
Time Frame	weekly

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Hip Strengthening Then Combined Exercises	Quadricep Group Then Combined Exercises
Arm/Group Description	Performed hip strengthening exercises for 4 weeks prior to crossing over to a combined hip and quadricep rehabilitation program	Performed quadricep strengthening exercises for 4 weeks prior to crossing over to a combined hip and quadricep rehabilitation program
Measure Participants	17	16
Mean (Standard Deviation) [centimeter]	4.5 (2.5)	4.2 (2.2)

2. Primary Outcome

Title	Subjective Function by Lower Extremity Functional Scale Report Form
Time Frame	Baseline, Mid-Intervention, and Post-Intervention

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

3. Secondary Outcome

Title	Strength by Isometric Dynamometer
Time Frame	Baseline, Mid, and Post-Intervention

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

4. Secondary Outcome

Title	Neuromuscular Activity by Surface Electromyographical Amplitude During Stair Descent
Time Frame	Baseline, Mid and Post-Intervention

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

5. Secondary Outcome

Title	Objective Function by Step-down Task for 30 Seconds
Time Frame	Baseline, Mid, and Post-Intervention

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

6. Secondary Outcome

Title	Hip Abduction Strength
Description	Side lying Hip Abduction maximal muscular contraction with a hand held dynamometer
Time Frame	8 week

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Hip Strengthening Then Combined Exercises	Quadricep Group Then Combined Exercises
Arm/Group Description	Performed hip strengthening exercises for 4 weeks prior to crossing over to a combined hip and quadricep rehabilitation program	Performed quadricep strengthening exercises for 4 weeks prior to crossing over to a combined hip and quadricep rehabilitation program
Measure Participants	17	16
Mean (Standard Deviation) [(Newton*meters)/(Weight*Height)]	6.6 (.9)	6.2 (1.8)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Hip Strengthening Then Combined Exercises, Quadricep Group Then Combined Exercises
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	.041
	Comments
	Method	ANOVA
	Comments

7. Primary Outcome

Title	Visual Analog Pain Scale
Description	Visual analog pain scale at end of intervention. 0 to 10 cm line with 0 representing no pain and 10 representing severe pain
Time Frame	8 week

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Hip Strengthening Then Combined Exercises	Quadricep Group Then Combined Exercises
Arm/Group Description	Performed hip strengthening exercises for 4 weeks prior to crossing over to a combined hip and quadricep rehabilitation program	Performed quadricep strengthening exercises for 4 weeks prior to crossing over to a combined hip and quadricep rehabilitation program
Measure Participants	17	16
Mean (Standard Deviation) [centimeters]	2.4 (2.8)	2.6 (2.0)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Hip Strengthening Then Combined Exercises, Quadricep Group Then Combined Exercises
	Comments	Repeated measures ANOVA for group and time
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	.049
	Comments
	Method	ANOVA
	Comments

Adverse Events

Time Frame	During the study and for 6 months following the study
Arm/Group Title	Hip Strengthening Then Combined Exercises		Quadricep Group Then Combined Exercises
Arm/Group Description	Performed hip strengthening exercises for 4 weeks prior to crossing over to a combined hip and quadricep rehabilitation program		Performed quadricep strengthening exercises for 4 weeks prior to crossing over to a combined hip and quadricep rehabilitation program
All Cause Mortality
	Hip Strengthening Then Combined Exercises		Quadricep Group Then Combined Exercises
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Hip Strengthening Then Combined Exercises		Quadricep Group Then Combined Exercises
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/17 (0%)		0/16 (0%)
Other (Not Including Serious) Adverse Events
	Hip Strengthening Then Combined Exercises		Quadricep Group Then Combined Exercises
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/17 (0%)		0/16 (0%)

Limitations/Caveats

Early termination leading to small number of subjects analyzed. Intention to treat analysis, last score carried forward, was used to analyze all outcome data.

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.