Patellofemoral Pain SyndromeNCT05083897
Effect of Hip Adductors Isometric Contraction on Knee Extensors Isokinetic Torque in Patellofemoral Pain Syndrome
An observational study of Patellofemoral Pain Syndrome, run by Badr University.
Trial summary
the study will be done to investigate the effect of hip adduction isometric contraction on the pain level by VAS and knee extensors peak torque by using the isokinetic dynamometer in patients with unilateral patellofemoral pain syndrome Read more about this study
- Who is it for?
- Ages 18 to 35 years
- Conditions the study is for
- Patellofemoral Pain Syndrome
- What is being tested?
- hip adduction isometric contraction
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Oct 2021to Dec 2021
- Phase
- Observational
- 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
- All sexes
- No healthy volunteers
- Adult
Study population: patients suffering from unilateral patellofemoral pain syndrome
Who may be able to join
- Anterior or retro-patellar knee pain from at least 2 of the following Activities: (1) prolonged sitting; (2) stair climbing; (3) squatting; (4) running; (5) kneeling; and (6) hopping/jumping (Tyler et al., 2006).
- Insidious onset of symptoms unrelated to a traumatic incident and persistent for at least 6 weeks (subacute or chronic pain).
- They will be diagnosed as a PFPS case by a physician
- The patient's age will be ranged from 18-35 years to limit the possibility that PFPS over age 35 may have been complicated by arthritic changes, and also the patients should have closed epiphyseal growth plates (Robinson and Nee, 2007).
Who cannot join
- A history of any of the following condition: meniscal or other intra articular pathologic conditions; cruciate or collateral ligament involvement.
- A history of traumatic patellar subluxation or dislocation.
- Previous surgery in the knee and hip joints.
- Any lower limb bony/congenital deformity.
- Ankle, Knee and hip joints osteoarthritis.
- A history of any conditions affects muscle strength: diabetes mellitus, rheumatoid arthritis.
- Pregnancy.
Trial locations and contacts
No sites are listed yet.
About this study
the study will be done to investigate the effect of hip adduction isometric contraction on the pain level by VAS and knee extensors peak torque by using the isokinetic dynamometer in patients with unilateral patellofemoral pain syndrome
Read the detailed description
the study will be done to investigate the effect of isometric hip adduction that will be measured by the hand held dynamometer (the manual muscle tester) to measure the produced adduction torque and its effect on the peak torque of knee extension by the knee extensors which will be measured by the isokinetic dynamometer in addition to measuring the pain intensity before and through the assessment by using the visual analogue scale
- Conditions
- Patellofemoral Pain Syndrome
- Being tested
- hip adduction isometric contraction
- Keywords
- PFPS
- 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.
hip adduction isometric contractionOther
addition of isometric hip adduction contraction to the knee extension for measuring knee extension peak torque by the isokinetic dynamometer
| Study group | Role | What they receive |
|---|---|---|
| 30 patients in 1 group | measuring the effect of isometric hip adduction with knee extension on the peak torque of knee extensors Receives: Other: hip adduction isometric contraction |
What is being measured
The primary outcome is the main question the study is designed to answer.
peak torque of knee extensors
the maximum rotatory force that can be generated by the knee extensor muscles measured by the isokinetic dynamometer
Measured: 2 months
pain level at the patellofemoral area
pain will be measured around the patellofemoral area by the visual analogue scale
Measured: 2 months
hip adduction peak torque
hip adduction maximum rotatory force measured by the hand held dynamometer
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2021
- Study startOct 2021 (estimated)
- Primary completionNov 2021 (estimated)
- Study completionDec 2021 (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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Badr University
- Sponsor type
- University, hospital or other
- Collaborators
- Cairo University
- Responsible party
- Principal investigator, Yasmine Ramadan, Badr University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05083897
- Sponsor's protocol ID
- yasmine zaki
- Status last verified
- Oct 2021
- First submitted
- 6 Oct 2021
- Last updated
- 19 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: the outcomes can be used in future researches concerning this field of interest
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Hip Adductors Isometric Contraction on Knee Extensors Isokinetic Torque in Patellofemoral Pain Syndrome
- ClinicalTrials.gov ID
- NCT05083897
- Acronym / sponsor ID
- yasmine zaki
- Conditions
- Patellofemoral Pain Syndrome
- Keywords
- PFPS
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Badr UniversityUniversity, hospital or other
- Collaborators
- Cairo University
- Study start
- Oct 2021 (estimated)
- Primary completion
- Nov 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 19 Oct 2021 (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 study will be done to investigate the effect of hip adduction isometric contraction on the pain level by VAS and knee extensors peak torque by using the isokinetic dynamometer in patients with unilateral patellofemoral pain syndrome
Detailed description
the study will be done to investigate the effect of isometric hip adduction that will be measured by the hand held dynamometer (the manual muscle tester) to measure the produced adduction torque and its effect on the peak torque of knee extension by the knee extensors which will be measured by the isokinetic dynamometer in addition to measuring the pain intensity before and through the assessment by using the visual analogue scale
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 30 patients in 1 group | – | Other: hip adduction isometric contractionmeasuring the effect of isometric hip adduction with knee extension on the peak torque of knee extensors |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- patients suffering from unilateral patellofemoral pain syndrome
Key inclusion criteria (4 listed)
- Anterior or retro-patellar knee pain from at least 2 of the following Activities: (1) prolonged sitting; (2) stair climbing; (3) squatting; (4) running; (5) kneeling; and (6) hopping/jumping (Tyler et al., 2006).
- Insidious onset of symptoms unrelated to a traumatic incident and persistent for at least 6 weeks (subacute or chronic pain).
- They will be diagnosed as a PFPS case by a physician
- The patient's age will be ranged from 18-35 years to limit the possibility that PFPS over age 35 may have been complicated by arthritic changes, and also the patients should have closed epiphyseal growth plates (Robinson and Nee, 2007).
Key exclusion criteria (7 listed)
- A history of any of the following condition: meniscal or other intra articular pathologic conditions; cruciate or collateral ligament involvement.
- A history of traumatic patellar subluxation or dislocation.
- Previous surgery in the knee and hip joints.
- Any lower limb bony/congenital deformity.
- Ankle, Knee and hip joints osteoarthritis.
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 |
|---|---|---|
| hip adduction isometric contractionaddition of isometric hip adduction contraction to the knee extension for measuring knee extension peak torque by the isokinetic dynamometer | Other | 30 patients in 1 group |
Primary outcome
peak torque of knee extensors
Time frame: 2 months
the maximum rotatory force that can be generated by the knee extensor muscles measured by the isokinetic dynamometer
pain level at the patellofemoral area
Time frame: 2 months
pain will be measured around the patellofemoral area by the visual analogue scale
hip adduction peak torque
Time frame: 2 months
hip adduction maximum rotatory force measured by the hand held dynamometer
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2021.
- Individual participant dataSharing planned: Undecided. the outcomes can be used in future researches concerning this field of interest
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Patellofemoral Pain Syndrome, run by Badr 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 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: status not confirmed, as of the sponsor's last update on 19 Oct 2021. 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 yasmin zaki, Bsc (01155667664, doc_yasminezaki23@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
peak torque of knee extensors (time frame: 2 months). 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?
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 19 Oct 2021.