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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00445224
Other study ID # 07-0138-F2L
Secondary ID
Status Completed
Phase Phase 2
First received March 6, 2007
Last updated July 30, 2015
Start date January 2008
Est. completion date January 2010

Study information

Verified date July 2015
Source University of Kentucky
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 33
Est. completion date January 2010
Est. primary completion date January 2010
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 15 Years to 35 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

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.
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.

Locations

Country Name City State
United States University of Kentucky Lexington Kentucky

Sponsors (1)

Lead Sponsor Collaborator
University of Kentucky

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Visual Analog Pain Scale (Describing Worst Pain Felt During the Past Week) 0 to 10 cm line with 0 representing no pain and 10 representing severe pain weekly No
Primary Subjective Function by Lower Extremity Functional Scale Report Form Baseline, Mid-Intervention, and Post-Intervention No
Primary Visual Analog Pain Scale Visual analog pain scale at end of intervention. 0 to 10 cm line with 0 representing no pain and 10 representing severe pain 8 week No
Secondary Strength by Isometric Dynamometer Baseline, Mid, and Post-Intervention No
Secondary Neuromuscular Activity by Surface Electromyographical Amplitude During Stair Descent Baseline, Mid and Post-Intervention No
Secondary Objective Function by Step-down Task for 30 Seconds Baseline, Mid, and Post-Intervention No
Secondary Hip Abduction Strength Side lying Hip Abduction maximal muscular contraction with a hand held dynamometer 8 week No
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