Patellofemoral Pain SyndromeNCT01804608
Kinematics of Lower Limb, Pain and Function of the Women With Patellofemoral Pain Syndrome
A study testing Strength 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, trunk and lower limbs kinematic during functional tasks after hip muscle strengthening versus hip muscle strengthening and sensory motor training in lower limbs. Read more about this study
- Who is it for?
- Ages 18 to 30 years, women only
- Conditions the study is for
- Patellofemoral Pain Syndrome
- What is being tested?
- Strength and Sensorimotor
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteBrazil
- Study dates
- Mar 2013to Feb 2015
- 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 30 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.
About this study
Official title: Kinematics of Lower Limb, Pain and Function of the Women With Patellofemoral Pain Syndrome Who Underwent Two Types Treatment: Randomized Clinical Trial
Assess pain, function, trunk and lower limbs kinematic during functional tasks after hip muscle strengthening versus hip muscle strengthening and sensory motor training in lower limbs.
- Conditions
- Patellofemoral Pain Syndrome
- Being tested
- Strength, 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.
StrengthOther
Also called Hip abductors and lateral rotators and knee extensors strengthening
SensorimotorOther
Also called Sensorimotor, balancing exercises, motor coordination, proprioceptive stimuli.
| Study group | Role | What they receive |
|---|---|---|
| Sensorimotor | Experimental | Sensorimotor, this arm will receive sensorimotor and hip muscle strengthening. Receives: Other: Sensorimotor |
| Strength | Active comparator | Strength, this arm will receive only hip muscle strengthening. Receives: Other: Strength |
What is being measured
The primary outcome is the main question the study is designed to answer.
Function and pain intensity
Measured: 4 weeks
Secondary outcomes (3)
Muscle strength of the hip and knee muscles
Measured: 4 weeks
Three-dimensional kinematics of the trunk and lower limbs during the step down task
Measured: 4 weeks
Function and pain intensity
Measured: 3 and 6 months after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2013 (estimated)
- Study startMar 2013
- Primary completionSep 2014
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Participant, Investigator
- Enrolment
- 34 participants (actual)
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
- NCT01804608
- Sponsor's protocol ID
- PL001
- Status last verified
- Oct 2016
- First submitted
- 28 Feb 2013
- Last updated
- 25 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Rabelo ND, Lima B, Reis AC, Bley AS, Yi LC, Fukuda TY, Costa LO, Lucareli PR. Neuromuscular training and muscle strengthening in patients with patellofemoral pain syndrome: a protocol of randomized controlled trial. BMC Musculoskelet Disord. 2014 May 16;15:157. doi: 10.1186/1471-2474-15-157.
PubMed 24884455
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Kinematics of Lower Limb, Pain and Function of the Women With Patellofemoral Pain Syndrome Who Underwent Two Types Treatment: Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT01804608
- Acronym / sponsor ID
- PL001
- Conditions
- Patellofemoral Pain Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- University of Nove de JulhoUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- Sep 2014 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 5 Mar 2013 (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, trunk and lower limbs kinematic during functional tasks after hip muscle strengthening versus hip muscle strengthening and sensory motor training in lower limbs.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sensorimotor | Experimental | Other: SensorimotorSensorimotor, this arm will receive sensorimotor and hip muscle strengthening. |
| Strength | Active comparator | Other: StrengthStrength, this arm will receive only hip muscle strengthening. |
Who may qualify
- Ages
- 18 to 30 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 |
|---|---|---|
| StrengthAlso: Hip abductors and lateral rotators and knee extensors strengthening | Other | Strength |
| SensorimotorAlso: Sensorimotor, balancing exercises, motor coordination, proprioceptive stimuli. | Other | Sensorimotor |
Primary outcome
Function and pain intensity
Time frame: 4 weeks
3 secondary outcomes
Muscle strength of the hip and knee muscles
Time frame: 4 weeks
Three-dimensional kinematics of the trunk and lower limbs during the step down task
Time frame: 4 weeks
Function and pain intensity
Time frame: 3 and 6 months after randomization
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 25 Oct 2016.
- Derived from this study: PubMed 24884455Rabelo ND, Lima B, Reis AC, Bley AS, Yi LC, Fukuda TY, Costa LO, Lucareli PR. Neuromuscular training and muscle strengthening in patients with patellofemoral pain syndrome: a protocol of randomized controlled trial. BMC Musculoskelet Disord. 2014 May 16;15:157. doi: 10.1186/1471-2474-15-157.
- Related InfoLink provided by the sponsor.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Strength 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: finished, as of the sponsor's last update on 25 Oct 2016. 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?
Function and pain intensity (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01804608, which also lists 1 linked publication.
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 25 Oct 2016.