- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03163290
Effect of Two Strengthening Protocols for Lower Limbs in Patients With Patellofemoral Pain
Effect of Two Strengthening Protocols for Lower Limbs in Patients With Patellofemoral Pain: Randomized Clinical Trial
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Ceará
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Fortaleza, Ceará, Brazil, 60430-160
- Federal University Of Ceara
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Posterolateral Hip Complex Exercises
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 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
|
Active Comparator: Anteromedial Hip Complex Exercises
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Numeric Pain Scale
Time Frame: Six weeks
|
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. |
Six weeks
|
Anterior Knee Pain Scale
Time Frame: Six weeks
|
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).
|
Six weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Numeric Pain Scale
Time Frame: Six months
|
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. |
Six months
|
Anterior Knee Pain Scale
Time Frame: Six months
|
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).
|
Six months
|
Numeric Pain Scale on Step Down Test
Time Frame: Six weeks
|
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. |
Six weeks
|
Dynamic Knee Valgus on Frontal Plane Projection Angle
Time Frame: Six weeks
|
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.
|
Six weeks
|
Global Effect Perception Scale
Time Frame: Six weeks
|
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.
|
Six weeks
|
Global Effect Perception Scale
Time Frame: Six months
|
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.
|
Six months
|
Muscle strength
Time Frame: Six weeks
|
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).
|
Six weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TCC_LARISSA NEVES
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
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