Patellofemoral Pain SyndromePhase 1/2PFPSNCT01691170
Comparison of Two Protocols for Patellofemoral Pain Syndrome
A Phase 1/2 study testing Stretching Hamstring and Quadriceps Strengthening in people with Patellofemoral Pain Syndrome, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
The patellofemoral pain syndrome (PFPS) is defined as a painful complaint in the anterior aspect of the knee, although peripatellar pain and / or retropatellar are also common. In general, conservative treatment is the initial option of choice for patients with PFPS, however, the lack of a specific causal factor makes… Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Patellofemoral Pain Syndrome
- What is being tested?
- Stretching Hamstring and Quadriceps Strengthening
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteBrazil
- Study dates
- Mar 2008to Sep 2011
- Phase
- Phase 1/2
- 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 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Symptoms of anterior knee pain for at least 1 moth;
- Average pain level of 3 or more on a 10-cm visual analogue scale during stepping up and down a 25-cm height;
- Anterior or retropatellar knee pain on at least 2 of the following activities: prolonged sitting, climbing stairs, squatting, running, kneeling, and hopping/jumping;
- Presence of 2 of the following clinical criteria on assessment: pain during apprehension test, pain during the patellar compression test, and crepitation during the compression test.
Who cannot join
- Previous knee surgery or arthritis;
- History of patellar dislocation or subluxation, malalignment, or ligament laxity;
- Patellar tendon pathology or chondral damage;
- Spinal referred pain;
- History of other abnormalities such as leg length inequalities (>2 cm);
- Medication as a part of the treatment;
- Previous physical therapy or acupuncture treatment for the knee within the previous 30 days.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Physical Therapy, Speech and Occupational Therapy Department, University of São Paulo.
São Paulo, São Paulo, 05360-000
About this study
Official title: Quadriceps Femoris Strengthening Versus Hamstring Stretching for Patellofemoral Pain Syndrome: A Randomized Clinical Trial.
The patellofemoral pain syndrome (PFPS) is defined as a painful complaint in the anterior aspect of the knee, although peripatellar pain and / or retropatellar are also common. In general, conservative treatment is the initial option of choice for patients with PFPS, however, the lack of a specific causal factor makes it difficult to choose the best treatment so early. This way, the purpose of this study is investigate the effects of the quadriceps femoris strengthening versus hamstring stretching in patients with pattellofemoral pain.
- Conditions
- Patellofemoral Pain Syndrome
- Being tested
- Stretching Hamstring, Quadriceps Strengthening
- Keywords
- Pattelofemoral pain syndrome, Stretching, Strengthening
- 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.
Stretching HamstringOther
Quadriceps StrengtheningOther
| Study group | Role | What they receive |
|---|---|---|
| Quadriceps Strengthening | Active comparator | Not described Receives: Other: Quadriceps Strengthening |
| Stretching Hamstring | Active comparator | Not described Receives: Other: Stretching Hamstring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric Pain Rating Scale
Pain was assessed using an 11-point numeric pain rating scale (NPRS), on which 0 denoted an absence of pain and 10 denoted unbearable pain.
Measured: Participants will be followed for the duration of 8 weeks.
Secondary outcomes (1)
Lysholm Scale
This questionnaire is made up of eight items with objective response options. The final score is expressed in nominal and ordinal form, as follows: 95 to 100 points - excellent; 84 to 94 points - good; 65 to 83 points - fair; and 64 or fewer points - poor.
Measured: Participants will be followed for the duration of 8 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2012 (estimated)
- Study startMar 2008
- Primary completionFeb 2011
- Study completionSep 2011
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.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gabriel Peixoto Leão Almeida, PT, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01691170
- Sponsor's protocol ID
- USP01
- Acronym
- PFPS
- Status last verified
- Sep 2012
- First submitted
- 16 Sep 2012
- Last updated
- 25 Sep 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quadriceps Femoris Strengthening Versus Hamstring Stretching for Patellofemoral Pain Syndrome: A Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT01691170
- Acronym / sponsor ID
- PFPS / USP01
- Conditions
- Patellofemoral Pain Syndrome
- Keywords
- Pattelofemoral pain syndrome, Stretching, Strengthening
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- Mar 2008
- Primary completion
- Feb 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 24 Sep 2012 (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.
The patellofemoral pain syndrome (PFPS) is defined as a painful complaint in the anterior aspect of the knee, although peripatellar pain and / or retropatellar are also common. In general, conservative treatment is the initial option of choice for patients with PFPS, however, the lack of a specific causal factor makes it difficult to choose the best treatment so early. This way, the purpose of this study is investigate the effects of the quadriceps femoris strengthening versus hamstring stretching in patients with pattellofemoral pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Quadriceps Strengthening | Active comparator | Other: Quadriceps Strengthening |
| Stretching Hamstring | Active comparator | Other: Stretching Hamstring |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Symptoms of anterior knee pain for at least 1 moth;
- Average pain level of 3 or more on a 10-cm visual analogue scale during stepping up and down a 25-cm height;
- Anterior or retropatellar knee pain on at least 2 of the following activities: prolonged sitting, climbing stairs, squatting, running, kneeling, and hopping/jumping;
- Presence of 2 of the following clinical criteria on assessment: pain during apprehension test, pain during the patellar compression test, and crepitation during the compression test.
Key exclusion criteria (7 listed)
- Previous knee surgery or arthritis;
- History of patellar dislocation or subluxation, malalignment, or ligament laxity;
- Patellar tendon pathology or chondral damage;
- Spinal referred pain;
- History of other abnormalities such as leg length inequalities (>2 cm);
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 |
|---|---|---|
| Stretching Hamstring | Other | Stretching Hamstring |
| Quadriceps Strengthening | Other | Quadriceps Strengthening |
Primary outcome
Numeric Pain Rating Scale
Time frame: Participants will be followed for the duration of 8 weeks.
Pain was assessed using an 11-point numeric pain rating scale (NPRS), on which 0 denoted an absence of pain and 10 denoted unbearable pain.
1 secondary outcome
Lysholm Scale
Time frame: Participants will be followed for the duration of 8 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 25 Sep 2012.
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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 Phase 1/2 study testing Stretching Hamstring and Quadriceps Strengthening in people with Patellofemoral Pain Syndrome, run by University of Sao Paulo 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 4 inclusion and 7 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 Sep 2012. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Rating Scale (time frame: Participants will be followed for the duration of 8 weeks.). 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 25 Sep 2012.