Patellofemoral Pain SyndromeNCT02250144
Foot Orthoses in Patellofemoral Pain Syndrome: a Prospective Randomized Study of Morpho-specific Versus Placebo Orthoses
A study testing Foot orthoses in people with Patellofemoral Pain Syndrome, run by University Hospital, Strasbourg, France at 3 sites in France.
Trial summary
Patellofemoral pain syndrome is one of the most common musculoskeletal disorders. It is defined as an anterior knee pain. Its origin is a conflict during patellar tracking, due to patellofemoral malalignment and soft tissue overload. Read more about this study
- Who is it for?
- Ages 12 to 40 years
- Conditions the study is for
- Patellofemoral Pain Syndrome
- What is being tested?
- Foot orthoses
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 3 sitesFrance
- Study dates
- Jun 2015to Aug 2016
- 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 12 to 40 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Male or female aged 12-40 years
- Patellofemoral pain syndrome
- Patient affiliated to a social protection regime
- Patient who signed an informed consent
- For teenagers with no complete growth and muscular maturation, failure of appropriate rehabilitation during minimum 2 months
- Patient informed of the results of the prior medical examination
- Normality (no sign of osteoarthritis) of the knee radiographs
- Ability to read and understand French
Who cannot join
- Knee osteoarthritis
- Systemic disease
- Inflammatory rheumatism disease
- Unstable knee
- Prior patellofemoral dislocation
- Osteochondrosis
Show all 17Show fewer
- Referred pain from a hip or spine disease (particularly proximal femoral epiphysiolysis in the teenagers)
- A history of patellar trauma
- A history of knee surgery
- Meniscus, ligament or osteochondral pathology
- Knee tendinitis or bursitis
- Neurologic disease
- Pregnancy
- Antidepressant therapy or behavioral disorder
- Patient unable to comply the required maximum observance
- Impossibility to give enlightened information to the patient
- Patient under guardianship
Trial locations and contacts
3 sites in 1 country.
France3 sites, 3 recruiting
- Recruiting
Cabinet libéral - 12, rue du Puits
Haguenau, 67500
Joseph ARNDT, MD, joseph.arndt@hotmail.fr
Joseph ARNDT, MD
- Recruiting
Service de Chirurgie Orthopédique - Hôpital CCOM - Hôpitaux Universitaires de Strasbourg
Illkirch-Graffenstaden, 67400
Yann DIESINGER, MD, 388552310 ext. 0033, yann.diesinger@chru-strasbourg.fr
Yann DIESINGER, MD
- Recruiting
Cabinet libéral - 50, avenue des Vosges
Strasbourg, 67000
Christian LUTZ, MD, lutzortho@wanadoo.fr
Christian LUTZ, MD
About this study
Patellofemoral pain syndrome is one of the most common musculoskeletal disorders. It is defined as an anterior knee pain. Its origin is a conflict during patellar tracking, due to patellofemoral malalignment and soft tissue overload.
A few recent studies seem to show a benefit of prefabricated feet orthoses in patellofemoral pain syndrome, alone or in association with rehabilitation. However, no one has analyzed the outcome of morpho-specific foot orthoses in a prospective randomized study.
Read more
The purpose of this prospective randomized study is to compare clinical outcomes in daily living and in sports activities, between morpho-specific and placebo foot orthoses.
Morpho-specific foot orthoses are designed according to the patient's morphotype. They are intended to correct structural defects of the hindfoot, midfoot and forefoot, in the aim to correct abnormal overload during patellofemoral tracking.
- Conditions
- Patellofemoral Pain Syndrome
- Being tested
- Foot orthoses
- Keywords
- Patellofemoral pain syndrome, Feet orthoses, KOOS
- 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.
Foot orthosesDevice
| Study group | Role | What they receive |
|---|---|---|
| Morpho-specific foot orthoses | Experimental | Morpho-specific thermo-molded foot orthoses are designed according to the patient's morphotype.
Orthoses are custom-molded from different materials such as BIOFLUX resin, Covercuir MF, EVA300/60, EVA400/70, PE255/55, ABSORB Dur and CAPITON PU. Receives: Device: Foot orthoses |
| Placebo foot orthoses | Placebo comparator | The placebo foot orthoses will be made with the same principle of molding and with the same materials as for the experimental group. The only difference is that they involve no active corrective insert element : they will be made without morphotype correction. Receives: Device: Foot orthoses |
What is being measured
The primary outcome is the main question the study is designed to answer.
Item Pain of the KOOS Score
Measured: Twice : at inclusion and at 10 weeks follow-up with feet orthoses
Secondary outcomes (3)
KOOS Score (items Symptoms, Activities of daily living, Sport and recreation function, Knee-related quality of life)
Measured: Twice : at inclusion and at 10 weeks follow-up with feet orthoses
Kujala Score
Measured: Twice : at inclusion and at 10 weeks follow-up with feet orthoses
Pain level
Visual Analog Scale (VAS)
Measured: Twice : at inclusion and at 10 weeks follow-up with feet orthoses
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2014 (estimated)
- Study startJun 2015
- Primary completionAug 2016 (estimated)
- Study completionAug 2016 (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.
- More trials run by University Hospital, Strasbourg, FranceThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02250144
- Sponsor's protocol ID
- 5832
- Status last verified
- Aug 2015
- First submitted
- 16 Sep 2014
- Last updated
- 7 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Foot Orthoses in Patellofemoral Pain Syndrome: a Prospective Randomized Study of Morpho-specific Versus Placebo Orthoses
- ClinicalTrials.gov ID
- NCT02250144
- Acronym / sponsor ID
- 5832
- Conditions
- Patellofemoral Pain Syndrome
- Keywords
- Patellofemoral pain syndrome, Feet orthoses, KOOS
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- Jun 2015
- Primary completion
- Aug 2016 (estimated)
- Study completion
- Aug 2016 (estimated)
- First posted
- 26 Sep 2014 (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.
Patellofemoral pain syndrome is one of the most common musculoskeletal disorders. It is defined as an anterior knee pain. Its origin is a conflict during patellar tracking, due to patellofemoral malalignment and soft tissue overload.
A few recent studies seem to show a benefit of prefabricated feet orthoses in patellofemoral pain syndrome, alone or in association with rehabilitation. However, no one has analyzed the outcome of morpho-specific foot orthoses in a prospective randomized study.
The purpose of this prospective randomized study is to compare clinical outcomes in daily living and in sports activities, between morpho-specific and placebo foot orthoses.
Morpho-specific foot orthoses are designed according to the patient's morphotype. They are intended to correct structural defects of the hindfoot, midfoot and forefoot, in the aim to correct abnormal overload during patellofemoral tracking.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Morpho-specific foot orthoses | Experimental | Device: Foot orthosesMorpho-specific thermo-molded foot orthoses are designed according to the patient's morphotype. Orthoses are custom-molded from different materials such as BIOFLUX resin, Covercuir MF, EVA300/60, EVA400/70, PE255/55, ABSORB Dur and CAPITON PU. |
| Placebo foot orthoses | Placebo comparator | Device: Foot orthosesThe placebo foot orthoses will be made with the same principle of molding and with the same materials as for the experimental group. The only difference is that they involve no active corrective insert element : they will be made without morphotype correction. |
Who may qualify
- Ages
- 12 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- Male or female aged 12-40 years
- Patellofemoral pain syndrome
- Patient affiliated to a social protection regime
- Patient who signed an informed consent
- For teenagers with no complete growth and muscular maturation, failure of appropriate rehabilitation during minimum 2 months
Key exclusion criteria (17 listed)
- Knee osteoarthritis
- Systemic disease
- Inflammatory rheumatism disease
- Unstable knee
- Prior patellofemoral dislocation
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 |
|---|---|---|
| Foot orthoses | Device | Morpho-specific foot orthoses, Placebo foot orthoses |
Primary outcome
Item Pain of the KOOS Score
Time frame: Twice : at inclusion and at 10 weeks follow-up with feet orthoses
3 secondary outcomes
KOOS Score (items Symptoms, Activities of daily living, Sport and recreation function, Knee-related quality of life)
Time frame: Twice : at inclusion and at 10 weeks follow-up with feet orthoses
Kujala Score
Time frame: Twice : at inclusion and at 10 weeks follow-up with feet orthoses
Pain level
Time frame: Twice : at inclusion and at 10 weeks follow-up with feet orthoses
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2015.
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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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Foot orthoses in people with Patellofemoral Pain Syndrome, run by University Hospital, Strasbourg, France at 3 sites in France.
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 8 inclusion and 17 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 7 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. 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. Some participants in this study may receive a placebo. 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 Yann DIESINGER, MD (388552310 ext. 0033, yann.diesinger@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Item Pain of the KOOS Score (time frame: Twice : at inclusion and at 10 weeks follow-up with feet orthoses). 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 7 Aug 2015.