Patellofemoral Pain Syndrome Clinical Prediction RuleNCT04481022
Developmental of Clinical Prediction Rule for Females Responding to Proximal Control Exercises
A study of Patellofemoral Pain Syndrome Clinical Prediction Rule, run by Cairo University.
Trial summary
the aim of study is to investigate the effect of body mass index (BMI), age, duration of symptoms, pain severity and knee angle valgus on patient̕̕s response to proximal control exercises. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women only
- Conditions the study is for
- Patellofemoral Pain Syndrome Clinical Prediction Rule
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 3 Sep 2020to 30 Aug 2021
- 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
- Age 18 to 35 years.
- Anterior or retropatellar knee pain of non-traumatic origin that was greater than six weeks duration and provoked by at least two predefined activities (prolonged sitting or kneeling, squatting, jogging or running, hopping, jumping, or stair walking).
- Pain on palpation of the patellar facets, or with step down from a 15 cm step, or double leg squat.
Who cannot join
- Concomitant injury or pathology of other knee structures.
- Previous knee surgery.
- patellofemoral instability (history of sublaxation or dislocation; positive apprehension test).
- knee joint effusion.
- Osgood-Schlatter's.
- hip or lumbar spine pain (local or referred).
- physiotherapy within previous year; prior foot orthoses treatment or use of anti inflammatories or corticosteroids.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Development of Clinical Prediction Rule for Classifying Females With Patellofemoral Pain Syndrome Who Respond to Proximal Control Exercises
the aim of study is to investigate the effect of body mass index (BMI), age, duration of symptoms, pain severity and knee angle valgus on patient̕̕s response to proximal control exercises.
Read the detailed description
Patellofemoral pain syndrome (PFPS) is recognized as one of the most common lower-extremity disorders encountered by orthopaedic physical therapists. Females were 2.23 times more likely to develop PFPS than males. Various authors have suggested that hip weakness may be an impairment associated with PFPS, because poor hip control may lead to abnormal lower extremity or patellofemoral motions. Clinical prediction rules (CPRs) are tools designed to improve decision making in clinical practice by assisting practitioners in making a particular diagnosis, establishing a prognosis, or matching patients to optimal interventions.
- Being tested
- proximal control exercises
- Keywords
- clinical predicton rule, proximal control exercises
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
proximal control exercisesOther
study investigates the effectiveness of proximal control exercises for patients with PFPS in improving pain and function. The findings of this systematic review are consistent with previous evidence reporting effectiveness of exercise for PFPS. In particular, there is consistent moderate to high quality evidence (three RCT, one CCT, three cohort studies, and one case series) that proximal interventions provide relief of pain and improved function in the short term, whereas the knee programs have variable effectiveness. Physical therapists should consider using proximal interventions for early stage treatment for PFPS (Peters et al., 2013).
After 4 weeks of a combined knee and hip strengthening exercise program, sedentary females with PFPS had a greater reduction in pain during stair descent compared to the group who performed knee strengthening exercises only. Both groups also showed significant improvement in function and pain during stair ascent (Fakuda et al., 2010).
| Study group | Role | What they receive |
|---|---|---|
| group will receive proximal control exercises | Other | Not described Receives: Other: proximal control exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
level of pain
visual analogue scale 100-mm horizontal line anchored by word descriptors at each end by no the left and worst imaginable pain on the right
Measured: baseline
functional status
Kujala questionnaire is a 13-items knee specific self-report questionnaire. It documents response to six activities thought to be associated specifically with anterior knee pain syndrome (walking, running, jumping, climbing stairs, squatting, and sitting for prolonged periods with knees bent), as well as symptoms such as limp, inability to bear weight through the affected limb, swelling, abnormal patellar movement, muscle atrophy and limitation of knee flexion. This questionnaire was used to ssess the individual's functional status and PFPS experienced during specific functional tasks.
Measured: baseline
Dynamic knee valgus 2d frontal plane projection angle
2D frontal plane projection angle (FPPA) analysis to measure dynamic knee valgus. for 2D FPPA analysis, the centers of each of hip, knee and ankle joints will be determined using a standard tape measure, markers will be placed at the midpoint of the ankle malleoli for the center of the ankle joint, midpoint of the femoral condyles to approximate the center of the knee joint, and on the proximal thigh at the midpoint of the line from the anterior superior iliac spine to the knee joint center.
Measured: baseline
Secondary outcomes (1)
isometric muscle power of hip abductor and external rotation
Hand held dynamometer will be used to asses isomteric hip abductor and isometric hip external rotator power
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2020
- Study start3 Sep 2020 (estimated)
- Primary completion30 Apr 2021 (estimated)
- Study completion30 Aug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Patellofemoral Pain Syndrome Clinical Prediction RuleStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Khaled Alaa Eldin, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04481022
- Sponsor's protocol ID
- PFPS clinical prediction rule
- Status last verified
- Sep 2020
- First submitted
- 17 Jul 2020
- Last updated
- 3 Sep 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Robinson RL, Nee RJ. Analysis of hip strength in females seeking physical therapy treatment for unilateral patellofemoral pain syndrome. J Orthop Sports Phys Ther. 2007 May;37(5):232-8. doi: 10.2519/jospt.2007.2439.
PubMed 17549951Earl JE, Hoch AZ. A proximal strengthening program improves pain, function, and biomechanics in women with patellofemoral pain syndrome. Am J Sports Med. 2011 Jan;39(1):154-63. doi: 10.1177/0363546510379967. Epub 2010 Oct 7.
PubMed 20929936Lesher JD, Sutlive TG, Miller GA, Chine NJ, Garber MB, Wainner RS. Development of a clinical prediction rule for classifying patients with patellofemoral pain syndrome who respond to patellar taping. J Orthop Sports Phys Ther. 2006 Nov;36(11):854-66. doi: 10.2519/jospt.2006.2208.
PubMed 17154139
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of Clinical Prediction Rule for Classifying Females With Patellofemoral Pain Syndrome Who Respond to Proximal Control Exercises
- ClinicalTrials.gov ID
- NCT04481022
- Acronym / sponsor ID
- PFPS clinical prediction rule
- Keywords
- clinical predicton rule, proximal control exercises
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 3 Sep 2020 (estimated)
- Primary completion
- 30 Apr 2021 (estimated)
- Study completion
- 30 Aug 2021 (estimated)
- First posted
- 22 Jul 2020 (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.
the aim of study is to investigate the effect of body mass index (BMI), age, duration of symptoms, pain severity and knee angle valgus on patient̕̕s response to proximal control exercises.
Detailed description
Patellofemoral pain syndrome (PFPS) is recognized as one of the most common lower-extremity disorders encountered by orthopaedic physical therapists. Females were 2.23 times more likely to develop PFPS than males. Various authors have suggested that hip weakness may be an impairment associated with PFPS, because poor hip control may lead to abnormal lower extremity or patellofemoral motions. Clinical prediction rules (CPRs) are tools designed to improve decision making in clinical practice by assisting practitioners in making a particular diagnosis, establishing a prognosis, or matching patients to optimal interventions.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| group will receive proximal control exercises | Other | Other: proximal control exercises |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age 18 to 35 years.
- Anterior or retropatellar knee pain of non-traumatic origin that was greater than six weeks duration and provoked by at least two predefined activities (prolonged sitting or kneeling, squatting, jogging or running, hopping, jumping, or stair walking).
- Pain on palpation of the patellar facets, or with step down from a 15 cm step, or double leg squat.
Key exclusion criteria (7 listed)
- Concomitant injury or pathology of other knee structures.
- Previous knee surgery.
- patellofemoral instability (history of sublaxation or dislocation; positive apprehension test).
- knee joint effusion.
- Osgood-Schlatter's.
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 |
|---|---|---|
| proximal control exercisesstudy investigates the effectiveness of proximal control exercises for patients with PFPS in improving pain and function. The findings of this systematic review are consistent with previous evidence reporting effectiveness of exercise for PFPS. In particular, there is consistent moderate to high quality evidence (three RCT, one CCT, three cohort studies, and one case series) that proximal interventions provide relief of pain and improved function in the short term, whereas the knee programs have variable effectiveness. Physical therapists should consider using proximal interventions for early stage treatment for PFPS (Peters et al., 2013). After 4 weeks of a combined knee and hip strengthening exercise program, sedentary females with PFPS had a greater reduction in pain during stair descent compared to the group who performed knee strengthening exercises only. Both groups also showed significant improvement in function and pain during stair ascent (Fakuda et al., 2010). | Other | group will receive proximal control exercises |
Primary outcome
level of pain
Time frame: baseline
visual analogue scale 100-mm horizontal line anchored by word descriptors at each end by no the left and worst imaginable pain on the right
functional status
Time frame: baseline
Kujala questionnaire is a 13-items knee specific self-report questionnaire. It documents response to six activities thought to be associated specifically with anterior knee pain syndrome (walking, running, jumping, climbing stairs, squatting, and sitting for prolonged periods with knees bent), as well as symptoms such as limp, inability to bear weight through the affected limb, swelling, abnormal patellar movement, muscle atrophy and limitation of knee flexion. This questionnaire was used to ssess the individual's functional status and PFPS experienced during specific functional tasks.
Dynamic knee valgus 2d frontal plane projection angle
Time frame: baseline
2D frontal plane projection angle (FPPA) analysis to measure dynamic knee valgus. for 2D FPPA analysis, the centers of each of hip, knee and ankle joints will be determined using a standard tape measure, markers will be placed at the midpoint of the ankle malleoli for the center of the ankle joint, midpoint of the femoral condyles to approximate the center of the knee joint, and on the proximal thigh at the midpoint of the line from the anterior superior iliac spine to the knee joint center.
1 secondary outcome
isometric muscle power of hip abductor and external rotation
Time frame: baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2020.
- Background: PubMed 17549951Robinson RL, Nee RJ. Analysis of hip strength in females seeking physical therapy treatment for unilateral patellofemoral pain syndrome. J Orthop Sports Phys Ther. 2007 May;37(5):232-8. doi: 10.2519/jospt.2007.2439.
- Background: PubMed 20929936Earl JE, Hoch AZ. A proximal strengthening program improves pain, function, and biomechanics in women with patellofemoral pain syndrome. Am J Sports Med. 2011 Jan;39(1):154-63. doi: 10.1177/0363546510379967. Epub 2010 Oct 7.
- Background: PubMed 17154139Lesher JD, Sutlive TG, Miller GA, Chine NJ, Garber MB, Wainner RS. Development of a clinical prediction rule for classifying patients with patellofemoral pain syndrome who respond to patellar taping. J Orthop Sports Phys Ther. 2006 Nov;36(11):854-66. doi: 10.2519/jospt.2006.2208.
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.
Questions about this trial
What is this clinical trial studying?
A study of Patellofemoral Pain Syndrome Clinical Prediction Rule, run by Cairo University.
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 3 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: status not confirmed, as of the sponsor's last update on 3 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
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 khaled AlaaEldin Fetouh, Master (01090737464 ext. 20, drkhaled929292@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
level of pain (time frame: baseline). The study lists 3 primary outcomes in all. 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 NCT04481022, which also lists 3 linked publications.
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 3 Sep 2020.