Patellofemoral Pain SyndromeNCT03099512
The Foot Exercises in Patellofemoral Pain
A study testing SFE and Exercise in people with Patellofemoral Pain Syndrome and Anterior Knee Pain Syndrome, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
The purpose of this study is to investigate the additional effects of Short Foot Exercises on pain, biomechanical characteristics and functionality of lower extremity in patients with patellofemoral pain. Read more about this study
- Who is it for?
- Ages 25 to 60 years
- Conditions the study is for
- Patellofemoral Pain Syndrome, Anterior Knee Pain Syndrome, Pronation Deformity of the Foot
- What is being tested?
- SFE and Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 3 Apr 2017to 29 Sep 2017
- 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 25 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- aged between 25-60
- diagnosed as patellofemoral pain syndrome
Who cannot join
- Pregnancy
- Having walking disability
- Having a trauma, knee surgery or other arthritis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Foot Exercises on Pain, Biomechanical Characteristics and Functionality of Lower Extremity in Patients With Patellofemoral Pain
The purpose of this study is to investigate the additional effects of Short Foot Exercises on pain, biomechanical characteristics and functionality of lower extremity in patients with patellofemoral pain.
- Conditions
- Patellofemoral Pain Syndrome, Anterior Knee Pain Syndrome, Pronation Deformity of the Foot, Exercise, Pain, Biomechanics
- Being tested
- SFE, Exercise
- Keywords
- Patellofemoral pain, foot deformity, foot pronation, short foot exercise
- Medical subject headings
- Patellofemoral Pain Syndrome, Motor Activity, Pain, Foot Deformities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SFEOther
The 'short foot exercise' has been described as a means to isolate contraction of the plantar intrinsic muscles.
ExerciseOther
Exercises which improves muscle strength, ROM...
| Study group | Role | What they receive |
|---|---|---|
| Ex+SFE Group | Experimental | Individuals in this group who will perform exercises for knee and also short foot exercise Receives: Other: SFE; Other: Exercise |
| Ex Group | Active comparator | Individuals in this group who will perform exercises for knee only Receives: Other: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue Scale
Asked for expression of pain
Measured: Change from baseline pain 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 posted4 Apr 2017
- Study start3 Apr 2017
- Primary completion29 Sep 2017
- Study completion29 Sep 2017
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 Hacettepe 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pınar Kısacık, Hacettepe University
- Investigators
- Pınar Kısacık, Principal investigator, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03099512
- Sponsor's protocol ID
- GO 17/168
- Status last verified
- Jan 2020
- First submitted
- 18 Mar 2017
- Last updated
- 14 Jan 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Foot Exercises on Pain, Biomechanical Characteristics and Functionality of Lower Extremity in Patients With Patellofemoral Pain
- ClinicalTrials.gov ID
- NCT03099512
- Acronym / sponsor ID
- GO 17/168
- Conditions
- Patellofemoral Pain Syndrome, Anterior Knee Pain Syndrome, Pronation Deformity of the Foot, Exercise, Pain, Biomechanics
- Keywords
- Patellofemoral pain, foot deformity, foot pronation, short foot exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 3 Apr 2017 (actual)
- Primary completion
- 29 Sep 2017 (actual)
- Study completion
- 29 Sep 2017 (actual)
- First posted
- 4 Apr 2017 (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 purpose of this study is to investigate the additional effects of Short Foot Exercises on pain, biomechanical characteristics and functionality of lower extremity in patients with patellofemoral pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ex+SFE Group | Experimental | Other: SFE, Other: ExerciseIndividuals in this group who will perform exercises for knee and also short foot exercise |
| Ex Group | Active comparator | Other: ExerciseIndividuals in this group who will perform exercises for knee only |
Who may qualify
- Ages
- 25 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- aged between 25-60
- diagnosed as patellofemoral pain syndrome
Key exclusion criteria (3 listed)
- Pregnancy
- Having walking disability
- Having a trauma, knee surgery or other arthritis
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 |
|---|---|---|
| SFEThe 'short foot exercise' has been described as a means to isolate contraction of the plantar intrinsic muscles. | Other | Ex+SFE Group |
| ExerciseExercises which improves muscle strength, ROM... | Other | Ex Group, Ex+SFE Group |
Primary outcome
Visual Analogue Scale
Time frame: Change from baseline pain at 6th week
Asked for expression of pain
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 14 Jan 2020.
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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.
Pınar Kısacık principal investigator
Hacettepe University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SFE and Exercise in people with Patellofemoral Pain Syndrome and Anterior Knee Pain Syndrome, run by Hacettepe University at 1 site in Turkey (Türkiye).
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 3 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 14 Jan 2020. 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 Turkey (Türkiye). 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?
Visual Analogue Scale (time frame: Change from baseline pain at 6th week). 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 14 Jan 2020.