Patellofemoral Pain SyndromeNCT02591680
The Effect of Muscle Strengthening Associated With Neuromuscular Stimulus in Patients With Patellofemoral Pain During Negotiating Stairs
A study testing Neuromuscular training, Muscle strengthening and Sensorimotor in people with Patellofemoral Pain Syndrome, run by University of Nove de Julho at 1 site in Brazil.
Trial summary
Assess pain, function, hip and knee strength and kinematics of trunk and lower limbs during ascent and descent stairs after the addition of neuromuscular training to hip muscle strengthening. 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?
- Neuromuscular training, Muscle strengthening and Sensorimotor
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteBrazil
- Study dates
- Mar 2015to Dec 2016
- 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
- Sedentary women,
- previous knee pain last 3 months in at least two of the following activities: sitting for long periods, walk up or down stairs, squat, running and jumping
Who cannot join
- Lower limb surgery,
- patella displacement
- knee instability
- Heart or locomotor disorders which might influence the evaluation
Trial locations and contacts
1 site in 1 country.
Paulo Lucareli contact
Brazil1 site, 1 recruiting
- Recruiting
Universidade Nove de Julho
São Paulo, São Paulo, 02020000
Paulo Lucareli, plucareli@uninove.br
About this study
Official title: The Effect of Muscle Strengthening Associated With Neuromuscular Stimulus in Patients With Patellofemoral Pain During Negotiating Stairs: A Randomized Controlled Trial
Assess pain, function, hip and knee strength and kinematics of trunk and lower limbs during ascent and descent stairs after the addition of neuromuscular training to hip muscle strengthening.
- Conditions
- Patellofemoral Pain Syndrome
- Being tested
- Neuromuscular training, Muscle strengthening, Sensorimotor
- 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.
Neuromuscular trainingOther
Also called Sensorimotor, balancing exercises, proprioceptive stimuli.
Muscle strengtheningOther
Also called Hip abductors and lateral rotators and knee extensors strengthening
SensorimotorDevice
| Study group | Role | What they receive |
|---|---|---|
| Neuromuscular training | Experimental | Neuromuscular, this arm will receive neuromuscular training and muscle strengthening. Receives: Other: Neuromuscular training; Device: Sensorimotor |
| Strength | Active comparator | Strength, this arm will receive only muscle strengthening. Receives: Other: Muscle strengthening |
What is being measured
The primary outcome is the main question the study is designed to answer.
3D kinematic range of motion of hip adduction during ascending and descending stairs
Kinematic analysis during ascent and descent stairs
Measured: 4 weeks
3D kinematic range of motion of hip internal rotation during ascending and descending stairs
Kinematic analysis during ascent and descent stairs
Measured: 4 weeks
Secondary outcomes (3)
Pain Scores on the Numerical Pain Rating Scale
Measured: 4 weeks
Strength of hip and knee extensor muscles measured through hand-held dynamometer
Measured: 4 weeks
Lower Limb Function measured through the questionnaires Anterior Knee Pain Scale -AKPS and Functional Index Questionnaire- FIQ .
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2015 (estimated)
- Study startMar 2015
- Primary completionMar 2016 (estimated)
- Study completionDec 2016 (estimated)
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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Nove de Julho
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paulo Roberto Garcia Lucareli, University of Nove de Julho
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02591680
- Sponsor's protocol ID
- PL004
- Status last verified
- Oct 2015
- First submitted
- 26 Oct 2015
- Last updated
- 29 Oct 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Muscle Strengthening Associated With Neuromuscular Stimulus in Patients With Patellofemoral Pain During Negotiating Stairs: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02591680
- Acronym / sponsor ID
- PL004
- Conditions
- Patellofemoral Pain Syndrome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- University of Nove de JulhoUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Mar 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 29 Oct 2015 (estimated)
- 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.
Assess pain, function, hip and knee strength and kinematics of trunk and lower limbs during ascent and descent stairs after the addition of neuromuscular training to hip muscle strengthening.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Neuromuscular training | Experimental | Other: Neuromuscular training, Device: SensorimotorNeuromuscular, this arm will receive neuromuscular training and muscle strengthening. |
| Strength | Active comparator | Other: Muscle strengtheningStrength, this arm will receive only muscle strengthening. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Sedentary women,
- previous knee pain last 3 months in at least two of the following activities: sitting for long periods, walk up or down stairs, squat, running and jumping
Key exclusion criteria (4 listed)
- Lower limb surgery,
- patella displacement
- knee instability
- Heart or locomotor disorders which might influence the evaluation
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 |
|---|---|---|
| Neuromuscular trainingAlso: Sensorimotor, balancing exercises, proprioceptive stimuli. | Other | Neuromuscular training |
| Muscle strengtheningAlso: Hip abductors and lateral rotators and knee extensors strengthening | Other | Strength |
| Sensorimotor | Device | Neuromuscular training |
Primary outcome
3D kinematic range of motion of hip adduction during ascending and descending stairs
Time frame: 4 weeks
Kinematic analysis during ascent and descent stairs
3D kinematic range of motion of hip internal rotation during ascending and descending stairs
Time frame: 4 weeks
Kinematic analysis during ascent and descent stairs
3 secondary outcomes
Pain Scores on the Numerical Pain Rating Scale
Time frame: 4 weeks
Strength of hip and knee extensor muscles measured through hand-held dynamometer
Time frame: 4 weeks
Lower Limb Function measured through the questionnaires Anterior Knee Pain Scale -AKPS and Functional Index Questionnaire- FIQ .
Time frame: 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2015.
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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.
Paulo Lucareli contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neuromuscular training, Muscle strengthening and Sensorimotor in people with Patellofemoral Pain Syndrome, run by University of Nove de Julho 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 2 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 29 Oct 2015. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Paulo Lucareli (551126339327), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
3D kinematic range of motion of hip adduction during ascending and descending stairs (time frame: 4 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 29 Oct 2015.