Patellofemoral Pain SyndromeNCT03163290
Effect of Two Strengthening Protocols for Lower Limbs in Patients With Patellofemoral Pain
A study testing Posterolateral Hip Complex Exercises and Anteromedial Hip Complex Exercises in people with Patellofemoral Pain Syndrome, run by Universidade Federal do Ceara at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women only
- Conditions the study is for
- Patellofemoral Pain Syndrome
- What is being tested?
- Posterolateral Hip Complex Exercises and Anteromedial Hip Complex Exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteBrazil
- Study dates
- 12 Jun 2017to 12 Mar 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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).
Who cannot join
- 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;
Show all 10Show fewer
- Patellar tendinopathy;
- Chondral lesion;
- Osteoarthritis;
- Muscle or joint injuries to the hip.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Two Strengthening Protocols for Lower Limbs in Patients With Patellofemoral Pain: Randomized Clinical Trial
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.
Read the 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.
- Conditions
- Patellofemoral Pain Syndrome
- Being tested
- Posterolateral Hip Complex Exercises, Anteromedial Hip Complex Exercises
- Medical subject headings
- Patellofemoral Pain Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Posterolateral Hip Complex ExercisesOther
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
Anteromedial Hip Complex ExercisesOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Posterolateral Hip Complex Exercises | Experimental | 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. Receives: Other: Posterolateral Hip Complex Exercises |
| Anteromedial Hip Complex Exercises | Active comparator | 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. Receives: Other: Anteromedial Hip Complex Exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Six weeks
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).
Measured: Six weeks
Secondary outcomes (7)
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.
Measured: Six months
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).
Measured: Six months
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.
Measured: Six weeks
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.
Measured: Six weeks
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.
Measured: Six weeks
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.
Measured: Six months
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).
Measured: Six weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2017
- Study start12 Jun 2017
- Primary completion12 Nov 2017
- Study completion12 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patellofemoral Pain SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Federal do Ceara
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gabriel Peixoto Leão Almeida, Universidade Federal do Ceara
- Investigators
- Gabriel PL Almeida, MSc, Principal investigator, Universidade Federal do Ceara
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03163290
- Sponsor's protocol ID
- TCC_LARISSA NEVES
- Status last verified
- Jul 2020
- First submitted
- 19 May 2017
- Last updated
- 21 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be shared.
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Two Strengthening Protocols for Lower Limbs in Patients With Patellofemoral Pain: Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03163290
- Acronym / sponsor ID
- TCC_LARISSA NEVES
- Conditions
- Patellofemoral Pain Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Universidade Federal do CearaUniversity, hospital or other
- Study start
- 12 Jun 2017 (actual)
- Primary completion
- 12 Nov 2017 (actual)
- Study completion
- 12 Mar 2019 (actual)
- First posted
- 23 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Posterolateral Hip Complex Exercises | Experimental | Other: Posterolateral Hip Complex ExercisesThe 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. |
| Anteromedial Hip Complex Exercises | Active comparator | Other: Anteromedial Hip Complex ExercisesThe 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. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (10 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Posterolateral Hip Complex ExercisesThe 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 | Other | Posterolateral Hip Complex Exercises |
| Anteromedial Hip Complex ExercisesThe 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. | Other | Anteromedial Hip Complex Exercises |
Primary outcome
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.
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).
7 secondary outcomes
Numeric Pain Scale
Time frame: Six months
Anterior Knee Pain Scale
Time frame: Six months
Numeric Pain Scale on Step Down Test
Time frame: Six weeks
Dynamic Knee Valgus on Frontal Plane Projection Angle
Time frame: Six weeks
Global Effect Perception Scale
Time frame: Six weeks
Global Effect Perception Scale
Time frame: Six months
Muscle strength
Time frame: Six weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2020.
- Individual participant dataSharing planned: No. IPD will not be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gabriel PL Almeida, MSc principal investigator
Universidade Federal do Ceara
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Posterolateral Hip Complex Exercises and Anteromedial Hip Complex Exercises in people with Patellofemoral Pain Syndrome, run by Universidade Federal do Ceara at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numeric Pain Scale (time frame: Six weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2020.