Patellofemoral Pain SyndromeNCT05383781
Effect of Short Foot Exercise in Treatment of Patients With Patellofemoral Pain Syndrome
A study testing Hip and Knee focused exercises and Short foot exercise in people with Patellofemoral Pain Syndrome, run by Cairo University.
Trial summary
Purposes of the study To investigate the effect of adding Short foot exercise on patellofemoral pain syndrome on knee Pain, Function, Balance and abductors, quadriceps Muscle strength. 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 and Knee focused exercises and Short foot exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- No sites listed yet
- Study dates
- Oct 2022to Nov 2023
- 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
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients diagnosed as PFPS
- Pain elicited at least by two of the following four tests; (i) Isometric muscle contraction with slight bent knee,(ii) palpation of the patellofemoral joint line, (iii) patellar compression against the femoral bone (iv) active resisted knee extension.
- Psychological and mentally stable
- No previous knee surgery, except for diagnostic arthroscopy.
- No current knee pathologies (e.g. osteoarthritis)
- Navicular drop test more than 10 mm which indicated pronated foot
Who cannot join
- Subjects will be excluded if they don't meet the inclusion criteria.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Effect of Adding Short Foot Exercise to Hip and Knee Focused Exercises in Treatment of Patients With Patellofemoral Pain Syndrome
Purposes of the study
To investigate the effect of adding Short foot exercise on patellofemoral pain syndrome on knee Pain, Function, Balance and abductors, quadriceps Muscle strength.
- Conditions
- Patellofemoral Pain Syndrome
- Being tested
- Hip and Knee focused exercises, Short foot exercise
- Keywords
- Short foot exercise, Patellofemoral pain syndrome
- 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 and Knee focused exercisesOther
Exercises which improves muscle strength, ROM
Short foot exerciseOther
The 'short foot exercise' has been described as a means to isolate contraction of the plantar intrinsic muscles.
| Study group | Role | What they receive |
|---|---|---|
| Hip and Knee exercise group | Active comparator | Individuals in this group will perform exercises for the Hip and knee only. Receives: Other: Hip and Knee focused exercises |
| Hip , Knee exercise and SFE group | Experimental | Individuals in this group will perform exercises for Hip , knee and also short foot exercise Receives: Other: Hip and Knee focused exercises; Other: Short foot exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
assessment of knee pain
by visual analogue scale ( VAS ) to assess knee pain -minimum score is 0 point and maximum score is 10. score of 10 means worst pain outcome
Measured: Change from baseline pain at 6th week
assessment of knee function
by Anterior Knee Pain Scale ( AKP )- minimum score is 0 point and maximum score is 100 points . score of 100 means no pain . this scale assesses knee pain and function
Measured: Change from baseline function at 6th week
Secondary outcomes (2)
Assessment of muscle strength
by Hand-Held Dynamometer (HHD):
Measured: Change from baseline at 6th week
Assessment of balance:
by Biodex Balance System is the device to assess balance and postural stability .
Measured: Change from baseline at 6th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2022
- Study startOct 2022 (estimated)
- Primary completionOct 2023 (estimated)
- Study completionNov 2023 (estimated)
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.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdallah Mohamed Kamel Mohamed Ali, Cairo University
- Investigators
- Abdallah Ali, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05383781
- Sponsor's protocol ID
- P.T.REC/012/003641
- Status last verified
- May 2022
- First submitted
- 13 May 2022
- Last updated
- 25 May 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kamel AM, Ghuiba K, Abd Allah DS, Fayaz NA, Abdelkader NA. Effect of adding short foot exercise to hip and knee focused exercises in treatment of patients with patellofemoral pain syndrome: a randomized controlled trial. J Orthop Surg Res. 2024 Apr 1;19(1):207. doi: 10.1186/s13018-024-04688-x.
PubMed 38561773
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Adding Short Foot Exercise to Hip and Knee Focused Exercises in Treatment of Patients With Patellofemoral Pain Syndrome
- ClinicalTrials.gov ID
- NCT05383781
- Acronym / sponsor ID
- P.T.REC/012/003641
- Conditions
- Patellofemoral Pain Syndrome
- Keywords
- Short foot exercise, Patellofemoral pain syndrome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Oct 2022 (estimated)
- Primary completion
- Oct 2023 (estimated)
- Study completion
- Nov 2023 (estimated)
- First posted
- 20 May 2022 (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.
Purposes of the study
To investigate the effect of adding Short foot exercise on patellofemoral pain syndrome on knee Pain, Function, Balance and abductors, quadriceps Muscle strength.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hip and Knee exercise group | Active comparator | Other: Hip and Knee focused exercisesIndividuals in this group will perform exercises for the Hip and knee only. |
| Hip , Knee exercise and SFE group | Experimental | Other: Hip and Knee focused exercises, Other: Short foot exerciseIndividuals in this group will perform exercises for Hip , knee and also short foot exercise |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Patients diagnosed as PFPS
- Pain elicited at least by two of the following four tests; (i) Isometric muscle contraction with slight bent knee,(ii) palpation of the patellofemoral joint line, (iii) patellar compression against the femoral bone (iv) active resisted knee extension.
- Psychological and mentally stable
- No previous knee surgery, except for diagnostic arthroscopy.
- No current knee pathologies (e.g. osteoarthritis)
Key exclusion criteria (1 listed)
- Subjects will be excluded if they don't meet the inclusion criteria.
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 and Knee focused exercisesExercises which improves muscle strength, ROM | Other | Hip , Knee exercise and SFE group, Hip and Knee exercise group |
| Short foot exerciseThe 'short foot exercise' has been described as a means to isolate contraction of the plantar intrinsic muscles. | Other | Hip , Knee exercise and SFE group |
Primary outcome
assessment of knee pain
Time frame: Change from baseline pain at 6th week
by visual analogue scale ( VAS ) to assess knee pain -minimum score is 0 point and maximum score is 10. score of 10 means worst pain outcome
assessment of knee function
Time frame: Change from baseline function at 6th week
by Anterior Knee Pain Scale ( AKP )- minimum score is 0 point and maximum score is 100 points . score of 100 means no pain . this scale assesses knee pain and function
2 secondary outcomes
Assessment of muscle strength
Time frame: Change from baseline at 6th week
Assessment of balance:
Time frame: Change from baseline at 6th week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2022.
- Derived from this study: PubMed 38561773Kamel AM, Ghuiba K, Abd Allah DS, Fayaz NA, Abdelkader NA. Effect of adding short foot exercise to hip and knee focused exercises in treatment of patients with patellofemoral pain syndrome: a randomized controlled trial. J Orthop Surg Res. 2024 Apr 1;19(1):207. doi: 10.1186/s13018-024-04688-x.
- Individual participant dataSharing planned: No
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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.
Abdallah Ali principal investigator
Cairo University
Questions about this trial
What is this clinical trial studying?
A study testing Hip and Knee focused exercises and Short foot exercise in people with Patellofemoral Pain Syndrome, 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 6 inclusion and 1 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 25 May 2022. 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 Abdallah Ali (+201144881439, abdallah.kamel@pt.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
assessment of knee pain (time frame: Change from baseline pain at 6th week). 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?
On the ClinicalTrials.gov record for NCT05383781, 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 May 2022.