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Comparison of Two Protocols for Patellofemoral Pain Syndrome (PFPS)

Primary Purpose

Patellofemoral Pain Syndrome

Status
Completed
Phase
Phase 1
Locations
Brazil
Study Type
Interventional
Intervention
Stretching Hamstring
Quadriceps Strengthening
Sponsored by
University of Sao Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Patellofemoral Pain Syndrome focused on measuring Pattelofemoral pain syndrome, Stretching, Strengthening

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Physical Therapy, Speech and Occupational Therapy Department, University of São Paulo.

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Quadriceps Strengthening

Stretching Hamstring

Arm Description

Outcomes

Primary Outcome Measures

Numeric Pain Rating Scale
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.

Secondary Outcome Measures

Lysholm Scale
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.

Full Information

First Posted
September 16, 2012
Last Updated
September 21, 2012
Sponsor
University of Sao Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT01691170
Brief Title
Comparison of Two Protocols for Patellofemoral Pain Syndrome
Acronym
PFPS
Official Title
Quadriceps Femoris Strengthening Versus Hamstring Stretching for Patellofemoral Pain Syndrome: A Randomized Clinical Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2012
Overall Recruitment Status
Completed
Study Start Date
March 2008 (undefined)
Primary Completion Date
February 2011 (Actual)
Study Completion Date
September 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo

4. Oversight

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Patellofemoral Pain Syndrome
Keywords
Pattelofemoral pain syndrome, Stretching, Strengthening

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Quadriceps Strengthening
Arm Type
Active Comparator
Arm Title
Stretching Hamstring
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Stretching Hamstring
Intervention Type
Other
Intervention Name(s)
Quadriceps Strengthening
Primary Outcome Measure Information:
Title
Numeric Pain Rating Scale
Description
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.
Time Frame
Participants will be followed for the duration of 8 weeks.
Secondary Outcome Measure Information:
Title
Lysholm Scale
Description
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.
Time Frame
Participants will be followed for the duration of 8 weeks.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Physical Therapy, Speech and Occupational Therapy Department, University of São Paulo.
City
São Paulo
ZIP/Postal Code
05360-000
Country
Brazil

12. IPD Sharing Statement

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Comparison of Two Protocols for Patellofemoral Pain Syndrome

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