- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01691170
Comparison of Two Protocols for Patellofemoral Pain Syndrome (PFPS)
September 21, 2012 updated by: Gabriel Peixoto Leão Almeida, PT, University of Sao Paulo
Quadriceps Femoris Strengthening Versus Hamstring Stretching for Patellofemoral Pain Syndrome: A Randomized Clinical Trial.
The patellofemoral pain syndrome (PFPS) is defined as a painful complaint in the anterior aspect of the knee, although peripatellar pain and / or retropatellar are also common.
In general, conservative treatment is the initial option of choice for patients with PFPS, however, the lack of a specific causal factor makes it difficult to choose the best treatment so early.
This way, the purpose of this study is investigate the effects of the quadriceps femoris strengthening versus hamstring stretching in patients with pattellofemoral pain.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
20
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
São Paulo, Brazil, 05360-000
- Physical Therapy, Speech and Occupational Therapy Department, University of São Paulo.
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 40 years (ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Symptoms of anterior knee pain for at least 1 moth;
- Average pain level of 3 or more on a 10-cm visual analogue scale during stepping up and down a 25-cm height;
- Anterior or retropatellar knee pain on at least 2 of the following activities: prolonged sitting, climbing stairs, squatting, running, kneeling, and hopping/jumping;
- Presence of 2 of the following clinical criteria on assessment: pain during apprehension test, pain during the patellar compression test, and crepitation during the compression test.
Exclusion Criteria:
- Previous knee surgery or arthritis;
- History of patellar dislocation or subluxation, malalignment, or ligament laxity;
- Patellar tendon pathology or chondral damage;
- Spinal referred pain;
- History of other abnormalities such as leg length inequalities (>2 cm);
- Medication as a part of the treatment;
- Previous physical therapy or acupuncture treatment for the knee within the previous 30 days.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
ACTIVE_COMPARATOR: Quadriceps Strengthening
|
|
|
ACTIVE_COMPARATOR: Stretching Hamstring
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Numeric Pain Rating Scale
Time Frame: Participants will be followed for the duration of 8 weeks.
|
Pain was assessed using an 11-point numeric pain rating scale (NPRS), on which 0 denoted an absence of pain and 10 denoted unbearable pain.
|
Participants will be followed for the duration of 8 weeks.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Lysholm Scale
Time Frame: Participants will be followed for the duration of 8 weeks.
|
This questionnaire is made up of eight items with objective response options.
The final score is expressed in nominal and ordinal form, as follows: 95 to 100 points - excellent; 84 to 94 points - good; 65 to 83 points - fair; and 64 or fewer points - poor.
|
Participants will be followed for the duration of 8 weeks.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2008
Primary Completion (ACTUAL)
February 1, 2011
Study Completion (ACTUAL)
September 1, 2011
Study Registration Dates
First Submitted
September 16, 2012
First Submitted That Met QC Criteria
September 19, 2012
First Posted (ESTIMATE)
September 24, 2012
Study Record Updates
Last Update Posted (ESTIMATE)
September 25, 2012
Last Update Submitted That Met QC Criteria
September 21, 2012
Last Verified
September 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- USP01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.