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Effect of Two Strengthening Protocols for Lower Limbs in Patients With Patellofemoral Pain

Primary Purpose

Patellofemoral Pain Syndrome

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Posterolateral Hip Complex Exercises
Anteromedial Hip Complex Exercises
Sponsored by
Universidade Federal do Ceara
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Patellofemoral Pain Syndrome

Eligibility Criteria

18 Years - 35 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Practicing physical activity for at least 3 times a week for at least 30 minutes;
  • Pain localized specifically around the patellofemoral joint, pain reproduced or reported in at least two of the following criteria: up or down stairs, squatting, kneeling, sitting for a long time, isometric contraction of the quadriceps, jumping, running and pain on palpation of the lateral and / or medial facet of the patella;
  • Report pain of insidious onset and lasting at least three months;
  • Pain at least three in the Numerical Pain Scale during the last week;
  • Report a maximum of 86 points on the Anterior Knee Pain Scale (maximum = 100 points).

Exclusion Criteria:

  • Previous surgery on the hip, knee, ankle and / or spine;
  • History of patellar dislocation;
  • Clinical evidence of knee instability (anterior and posterior drawer test, Lachman, varus and valgus stress);
  • Meniscal lesions or intra-articular lesions;
  • Evidence of edema;
  • Osgood-Schlatter syndrome or Sinding-Larsen-Johansson;
  • Patellar tendinopathy;
  • Chondral lesion;
  • Osteoarthritis;
  • Muscle or joint injuries to the hip.

Sites / Locations

  • Federal University of Ceara

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Posterolateral Hip Complex Exercises

Anteromedial Hip Complex Exercises

Arm Description

The intervention protocol will be composed of: Heating, lower limb stretching, strengthening the quadriceps, and hip abductors, lateral rotators and extensors. Posterolateral Hip Complex Exercises add extension knee in open kinetic chain, squat , abduction exercise, Clam exercise and external rotation exercise. Physiotherapy treatment sessions will last for an average of one hour, twice a week, for a period of six weeks.

The intervention protocol will be composed of: Heating, lower limb stretching, strengthening the quadriceps, and hip aductors, medial rotators and flexors. Anteromedial Hip Complex Exercises add extension knee in open kinetic chain, squat ,hip adduction exercise, adduction with a ring between the thighs and internal rotation exercise. Physiotherapy treatment sessions will last for an average of one hour, twice a week, for a period of six weeks.

Outcomes

Primary Outcome Measures

Numeric Pain Scale
Pain was assessed by use of an 11-point Numeric Pain Scale, where 0 corresponded to no pain and 10 corresponded to worst imaginable pain. to worst imaginable pain.
Anterior Knee Pain Scale
Anterior Knee Pain Scale assesses functional capacity and pain level during functional and specific activities for patients with PFP. This scale was translated and culturally adapted to the Brazilian Portuguese language,10 and the score ranges from 0 (worst) to 100 (best).

Secondary Outcome Measures

Numeric Pain Scale
Pain was assessed by use of an 11-point Numeric Pain Scale, where 0 corresponded to no pain and 10 corresponded to worst imaginable pain. to worst imaginable pain.
Anterior Knee Pain Scale
Anterior Knee Pain Scale assesses functional capacity and pain level during functional and specific activities for patients with PFP. This scale was translated and culturally adapted to the Brazilian Portuguese language,10 and the score ranges from 0 (worst) to 100 (best).
Numeric Pain Scale on Step Down Test
Pain was assessed by use of an 11-point Numeric Pain Scale on Step Down Test, where 0 corresponded to no pain and 10 corresponded to worst imaginable pain. to worst imaginable pain.
Dynamic Knee Valgus on Frontal Plane Projection Angle
The dynamic knee valgus was assessed by the FPPA during the forward step-down test filmed with a digital camera (60 fps). FPPA was measured by the angle formed by the intersection of the lines between the anterior superior iliac spine and the center of the malleoli at the center of the femoral condyles. The step height was normalized to 10% of the height of each participant. All participants performed two training tests and three valid tests, with a five-second cadence for each test. The FPPA was calculated at the time of the heel touch on the ground by the Kinovea® Video Editor program. We considered a positive value as dynamic valgus and a negative value as dynamic varus.
Global Effect Perception Scale
This scale has 11 points ranging from minus five points (extremely worse), Zero (no change) to five points (fully recovered). For all measures of perceived global effect the participants will be asked: "compared to the beginning of this episode, how would you describe your knee these days?" Positive scores represent better recovery and negative scores indicate worsening of symptoms.
Global Effect Perception Scale
This scale has 11 points ranging from minus five points (extremely worse), Zero (no change) to five points (fully recovered). For all measures of perceived global effect the participants will be asked: "compared to the beginning of this episode, how would you describe your knee these days?" Positive scores represent better recovery and negative scores indicate worsening of symptoms.
Muscle strength
Muscle strength of the hip abductors, adductors, lateral rotators and medial rotators will be assessed with a manual dynamometer (Nicholas Manual MuscleTester, Lafayette Instrument Company, Lafayette, Indiana, USA).

Full Information

First Posted
May 19, 2017
Last Updated
July 17, 2020
Sponsor
Universidade Federal do Ceara
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1. Study Identification

Unique Protocol Identification Number
NCT03163290
Brief Title
Effect of Two Strengthening Protocols for Lower Limbs in Patients With Patellofemoral Pain
Official Title
Effect of Two Strengthening Protocols for Lower Limbs in Patients With Patellofemoral Pain: Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
June 12, 2017 (Actual)
Primary Completion Date
November 12, 2017 (Actual)
Study Completion Date
March 12, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade Federal do Ceara

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Patellofemoral Pain (PFP) is one of the most common disorders that affecting the physically active population, and its incidence is higher among women. Despite the high incidence, the etiologies of this painful syndrome are still unclear. Research has verified the influence of hip stabilizers on knee injurie and has demonstrated a deficit of strength of the hip lateral rotator, abductors and extensors muscles in patients with PFP. The aim of this study is to compare the effectiveness of strengthening the Posterolateral Hip Complex with the Anteromedial Hip Complex associated with quadriceps strengthening for pain reduction and improvement of functional capacity in patients with PFP.
Detailed Description
The physical therapy sessions will average duration of one hour, often twice a week for six weeks. The exercise intensity will be monitored by the physiotherapist as determined by the participant's ability to complete 10 repetitions for a particular exercise and its difficulty of execution perceived by the modified Borg scale (CR-10). The exercises are performed with load between 60-80% of their capacity, the load will be increased from 2 to 10% when the patient can perform 14 full repetitions in the last series. It will be set to 30 seconds of rest between reps and 2 minutes between sets of exercise. Both groups will perform prior heating exercises bike for 5 minutes with moderate intensity with the Borg scale. Then there will be one stretche repetitions held for 45 seconds of muscle groups: hamstrings, quadriceps, abductors, adductors and gastrocnemius. Thus, they will be performed strengthening exercises in extension and knee in open kinetic chain and squat. The Posterolateral Hip Complex (PLC) add hip abduction exercise, Clam exercise and external rotation exercise. Studies prior point out that these exercises are among those withhigher electromyographic activity of the gluteus medius and maximus muscles. The Anteromedial Hip Complex (AMC) add hip adduction exercise, adduction with a ring between the thighs and internal rotation exercise. The exercises will be carried out to load 60-80% of 1 repetition maximum 8-12 reps, 1-3 sets and 2-3 times a week. All exercises are performed without worsening pain and intensity of exercise will be controlled according to the perceived exertion scale of Borg.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Patellofemoral Pain Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
52 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Posterolateral Hip Complex Exercises
Arm Type
Experimental
Arm Description
The intervention protocol will be composed of: Heating, lower limb stretching, strengthening the quadriceps, and hip abductors, lateral rotators and extensors. Posterolateral Hip Complex Exercises add extension knee in open kinetic chain, squat , abduction exercise, Clam exercise and external rotation exercise. Physiotherapy treatment sessions will last for an average of one hour, twice a week, for a period of six weeks.
Arm Title
Anteromedial Hip Complex Exercises
Arm Type
Active Comparator
Arm Description
The intervention protocol will be composed of: Heating, lower limb stretching, strengthening the quadriceps, and hip aductors, medial rotators and flexors. Anteromedial Hip Complex Exercises add extension knee in open kinetic chain, squat ,hip adduction exercise, adduction with a ring between the thighs and internal rotation exercise. Physiotherapy treatment sessions will last for an average of one hour, twice a week, for a period of six weeks.
Intervention Type
Other
Intervention Name(s)
Posterolateral Hip Complex Exercises
Intervention Description
The treatment protocol was composed of: Heating, lower limb stretching, strengthening the quadriceps e hip muscles. The following exercises were included: abduction exercise, Clam exercise and external rotation exercise
Intervention Type
Other
Intervention Name(s)
Anteromedial Hip Complex Exercises
Intervention Description
The treatment protocol was composed of: Heating, lower limb stretching, strengthening the quadriceps e hip muscles. The following exercises were included: hip adduction exercise, adduction with a ring between the thighs and internal rotation exercise.
Primary Outcome Measure Information:
Title
Numeric Pain Scale
Description
Pain was assessed by use of an 11-point Numeric Pain Scale, where 0 corresponded to no pain and 10 corresponded to worst imaginable pain. to worst imaginable pain.
Time Frame
Six weeks
Title
Anterior Knee Pain Scale
Description
Anterior Knee Pain Scale assesses functional capacity and pain level during functional and specific activities for patients with PFP. This scale was translated and culturally adapted to the Brazilian Portuguese language,10 and the score ranges from 0 (worst) to 100 (best).
Time Frame
Six weeks
Secondary Outcome Measure Information:
Title
Numeric Pain Scale
Description
Pain was assessed by use of an 11-point Numeric Pain Scale, where 0 corresponded to no pain and 10 corresponded to worst imaginable pain. to worst imaginable pain.
Time Frame
Six months
Title
Anterior Knee Pain Scale
Description
Anterior Knee Pain Scale assesses functional capacity and pain level during functional and specific activities for patients with PFP. This scale was translated and culturally adapted to the Brazilian Portuguese language,10 and the score ranges from 0 (worst) to 100 (best).
Time Frame
Six months
Title
Numeric Pain Scale on Step Down Test
Description
Pain was assessed by use of an 11-point Numeric Pain Scale on Step Down Test, where 0 corresponded to no pain and 10 corresponded to worst imaginable pain. to worst imaginable pain.
Time Frame
Six weeks
Title
Dynamic Knee Valgus on Frontal Plane Projection Angle
Description
The dynamic knee valgus was assessed by the FPPA during the forward step-down test filmed with a digital camera (60 fps). FPPA was measured by the angle formed by the intersection of the lines between the anterior superior iliac spine and the center of the malleoli at the center of the femoral condyles. The step height was normalized to 10% of the height of each participant. All participants performed two training tests and three valid tests, with a five-second cadence for each test. The FPPA was calculated at the time of the heel touch on the ground by the Kinovea® Video Editor program. We considered a positive value as dynamic valgus and a negative value as dynamic varus.
Time Frame
Six weeks
Title
Global Effect Perception Scale
Description
This scale has 11 points ranging from minus five points (extremely worse), Zero (no change) to five points (fully recovered). For all measures of perceived global effect the participants will be asked: "compared to the beginning of this episode, how would you describe your knee these days?" Positive scores represent better recovery and negative scores indicate worsening of symptoms.
Time Frame
Six weeks
Title
Global Effect Perception Scale
Description
This scale has 11 points ranging from minus five points (extremely worse), Zero (no change) to five points (fully recovered). For all measures of perceived global effect the participants will be asked: "compared to the beginning of this episode, how would you describe your knee these days?" Positive scores represent better recovery and negative scores indicate worsening of symptoms.
Time Frame
Six months
Title
Muscle strength
Description
Muscle strength of the hip abductors, adductors, lateral rotators and medial rotators will be assessed with a manual dynamometer (Nicholas Manual MuscleTester, Lafayette Instrument Company, Lafayette, Indiana, USA).
Time Frame
Six weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Practicing physical activity for at least 3 times a week for at least 30 minutes; Pain localized specifically around the patellofemoral joint, pain reproduced or reported in at least two of the following criteria: up or down stairs, squatting, kneeling, sitting for a long time, isometric contraction of the quadriceps, jumping, running and pain on palpation of the lateral and / or medial facet of the patella; Report pain of insidious onset and lasting at least three months; Pain at least three in the Numerical Pain Scale during the last week; Report a maximum of 86 points on the Anterior Knee Pain Scale (maximum = 100 points). Exclusion Criteria: Previous surgery on the hip, knee, ankle and / or spine; History of patellar dislocation; Clinical evidence of knee instability (anterior and posterior drawer test, Lachman, varus and valgus stress); Meniscal lesions or intra-articular lesions; Evidence of edema; Osgood-Schlatter syndrome or Sinding-Larsen-Johansson; Patellar tendinopathy; Chondral lesion; Osteoarthritis; Muscle or joint injuries to the hip.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gabriel PL Almeida, MSc
Organizational Affiliation
Universidade Federal do Ceara
Official's Role
Principal Investigator
Facility Information:
Facility Name
Federal University of Ceara
City
Fortaleza
State/Province
Ceará
ZIP/Postal Code
60430-160
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
IPD will not be shared.

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Effect of Two Strengthening Protocols for Lower Limbs in Patients With Patellofemoral Pain

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