PFPPFP-InhibitNCT02786784
The Role of Arthrogenic Muscular Inhibition in Patellofemoral Pain and the Response to an Exercise Programme
A study testing 6 week exercise treatment in people with PFP and Patellofemoral Pain, run by University of Salford at 1 site in United Kingdom.
Trial summary
Patellofemoral pain (PFP) is the most diagnosed condition in individuals with knee complaints. Studies revealed that one third of individuals with PFP suffer from persistent complaints, indicating that current treatments fail to prevent the chronicity of symptoms. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- PFP, Patellofemoral Pain, Anterior Knee Pain
- What is being tested?
- 6 week exercise treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jun 2016to Oct 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 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Reproducible pain with at least two of these activities: ascending or descending stairs or ramps, squatting, kneeling, prolonged sitting, hopping/ jumping, isometric quadriceps contraction or running
- Clearly defined pain location in the peripatellar region
- Reports of pain greater than 1 month duration.
- They are able to perform squatting, running and MVC task- Participant response
- Age range: 18-45 years old
- Healthy and without any previous lower limb injuries
- The participant is able to perform squatting, running and MVC task
Who cannot join
- Previous history of knee surgery
- Previous history of (traumatic) patella dislocation or instability
- Previous history of ligamentous instabilities
- Previous history of traumatic, inflammatory or infectious pathology in the lower extremity
- Previous history of internal derangement or other causes
- Previous diagnosed degenerative conditions in the knee
- Exclusion if patients cannot perform running, step down, or MVC task.
- Exclusion criteria for the healthy control group are: clinical evidence of other knee injury or knee pain, and current significant injury affecting other lower extremity joints.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
University of Salford
Salford, Greater Manchester, M66PU
Henrike Greuel, MSc, 0161 295 2017, H.Greuel@edu.salford.ac.uk
Richard K Jones, PhD, 0161 306 0549, R.K.Jones@salford.ac.uk
About this study
Patellofemoral pain (PFP) is the most diagnosed condition in individuals with knee complaints. Studies revealed that one third of individuals with PFP suffer from persistent complaints, indicating that current treatments fail to prevent the chronicity of symptoms. Considering that current treatment-strategies of patients with PFP seem to be unable to avoid the development of chronic symptoms, the question arises if the underlying factors of PFP are understood sufficiently. Current research focuses predominantly on muscle strength assessment by means of a maximum voluntary contraction (MVC), even though, weakness might not only be caused by a reduced voluntary contraction but also by an involuntary ability to contract the muscle fully, which is named arthrogenous muscular inhibition (AMI). Although AMI has been proven to be present in a wide range of knee joint pathologies to date it remains unclear whether patients with PFP are weak or inhibited. It remains also unclear if there exists a causal link between AMI and biomechanical alterations.
Previous studies investigated the influence of exercise treatment on muscular strength, function and pain. However, to date no study investigated the influence of the currently recommended exercise treatment on AMI. Thus, the analysis of the effect of a 6 week exercise treatment might yield further insights if a specific exercise treatment can reduce AMI, improve functional performance and reduce pain.
Read more
Methods: The investigators will invite 40 participants with PFP and 40 healthy controls to take part in the study. As a basis investigation kinematic, kinetic measures, and surface electromyographic (sEMG) of 4 lower limb muscles will be taken during functional tasks. Muscle strength and AMI of the quadriceps, muscle flexibility, and a posture assessment of the patella as well as the foot will be carried out. All participants with PFP will then receive a 6 week exercise programme to follow. After six weeks, the participants with PFP will attend the Salford university, where they will be reassessed.
Expected outcomes: The study will investigate if AMI is present in participants with PFP and if AMI is directly linked to functional performance. In addition this study will investigate if a specific exercise treatment can reduce AMI and improve functional performance.
Read the detailed description
Procedures The testing will be performed in the human performance laboratory at the University of Salford, Manchester. Upon arrival at the laboratory, the participants will be briefed through the study and the objectives of the investigations and the study equipment will be explained to them. They will be asked to sign the informed consent form, a health history questionnaire. The health history questionnaire consists of 13 questions investigating potential risks associated with the study.
The individual will then be asked to change into their shorts and a comfortable t-shirt.
Strength and arthrogenic muscle inhibition:
The muscular inhibition of the quadriceps will be assessed, during a maximal isometric contraction (MVIC) of the quadriceps with the interpolated twitch technique. The participants will perform 5 times a maximal contraction of their knee extensor and additional electrical stimulation will be applied, which will be performed on an isokinetic dynamometer (Kin-Com) with a knee flexion angle of 90°. Then the participant will be asked to perform 5 times an eccentric quadriceps contraction at the angular velocity of 60 degrees/ second, through the full available range of motion (ROM) from 90 degrees knee flexion to maximum knee extension, while the quadriceps torque will be measured.
Questionnaires:
The participants with PFP will then be asked to fill in 3 different questionnaires:
the KOOS, the AKPS/ Kujala score, and the Tampa Scale of Kinesiophobia.
After this recovery break, the posture and flexibility investigation will be executed. The examination of the foot posture will be performed by using the 6-item foot posture index (FPI-6). The patella alignment includes a lateral - medial displacement/ lateral -medial tilt), and a lateral-medial displacement assessment.
Flexibility:
The flexibility of the hamstrings and the soleus muscle will be assessed.
Biomechanics:
Following this, the researcher will attach 40 retro-reflective markers to the skin of the lower limb on both legs and attach surface electromyographic electrodes to four muscles as in figure 4 on both legs. The electrode placement will be performed according to the SENIAM guidelines. Suface EMG (sEMG) data will be collected of vastus medialis, vastus lateralis, biceps femoris and semitendinosus will be synchronised with the motion capture system on Qualisys.
After a static 3-dimensional image from ten infra-red cameras will be obtained. The 3D kinematics of the ankle, knee, and hip joint and ground reaction forces (GRF) will be recorded for each participant during a running, a single leg squat and a step down task.
Treatment:
The 6 week treatment will be exclusively conducted by physiotherapists at the Salford Royal Hospital (Salford Royal NHS Foundation Trust, SRFT).
Physiotherapist from the Salford Royal hospital will introduce the treatment programme to the participants. Additionally, each participants will receive a booklet with a detailed description of the treatment programme, as well as access to a password protected website (VIMEO) to watch the videos of all exercises.
Assessment of the treatment outcomes after 6 weeks At the end of the 6 weeks exercise intervention, the participants with PFP will then attend the human performance laboratory at the University of Salford. The muscle strength, AMI, flexibility, posture assessment, as well as the clinical assessment of running and a step down task of each individual will be measured to investigate the change in AMI and functional performance due to the treatment.
- Conditions
- PFP, Patellofemoral Pain, Anterior Knee Pain
- Being tested
- 6 week exercise treatment
- 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.
6 week exercise treatmentOther
This six-week exercise programme was developed based on the current recommendations, consisting of four exercises to strengthen gluteus medius and maximus muscle, as well as the quadriceps muscle. In addition, two exercises to stretch the hamstrings muscles and to increase the ankle dorsi range of motion were included.
| Study group | Role | What they receive |
|---|---|---|
| healthy control | Other | patients with patellofemoral pain Receives: Other: 6 week exercise treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Extent of the arthrogenic muscle inhibition (AMI)
AMI will be calculated from the ratio:
AMI = (resting twitch size in Nm/ twitch size during MVC in Nm)*100 AMI will be expressed in %. The differences between the baseline measurements and the measurements after 6 weeks of treatments will be investigated in participants with PFP.
Measured: 6 weeks
quadriceps/ hamstrings cocontraction
The cocontraction of the quadriceps (vastus medialis and lateralis) and the hamstring (biceps femoris and semitendinosus) was calculated by the formula developed by Heiden et al. 2009, whereby 0 expresses no cocontraction and 1 a complete cocontraction. The cocontraction will be calculated for for the early, mid, late stance phase, the single leg squat and single leg step down task. Differences between the baseline of participants with PFP and after 6 weeks after the treatment will be investigated.
Furthermore, the correlation between the external knee adduction moment (EKAM) to AMI will be investigated.
Measured: 6 weeks
Presence of the break phenomenon
The break phenomenon is defined as a trace dip during the eccentric quadriceps phase, which exceeds more than 10% of the pre-break moment. The break phenomenon will be defined as either: present or not present. The differences between the baseline measurements and the measurements after 6 weeks of treatments will be investigated in participants with PFP.
Measured: 6 weeks
Maximal knee adduction angle
The maximal knee adduction angle will be given for the early, mid, late stance phase, the single leg squat and single leg step down task and will be expressed in degrees. The differences between the baseline measurements and the measurements after 6 weeks of treatments will be investigated in participants with PFP.
Measured: 6 weeks
Maximal knee adductor moment (EKAM)
The maximal knee adductor moment will be given as % of the bodyweight (BW). The maximal EKAM will be investigated for early, mid, late stance phase, the single leg squat and single leg step down task. The differences between the baseline measurements and the measurements after 6 weeks of treatments will be investigated in participants with PFP.
Measured: 6 weeks
the knee adduction angular impulse (KAAI)
knee adduction angular impulse is defined as the integral of the knee adduction moment-time curve. The normalised KAAI will be given as % of the bodyweight (BW). The KAAI will be given for early, mid, late stance phase, the single leg squat and single leg step down task. The differences between the baseline measurements and the measurements after 6 weeks of treatments will be investigated in participants with PFP.
Measured: 6 weeks
Maximal knee internal rotation
The maximal knee internal rotation angle will be given for the early, mid, late stance phase, the single leg squat and single leg step down task and will be expressed in degrees. The differences between the baseline measurements and the measurements after 6 weeks of treatments will be investigated in participants with PFP.
Measured: 6 weeks
Maximal knee internal rotation moment
The maximal knee internal rotation moment will be given as % of the bodyweight (BW). The maximal knee internal rotation moment will be investigated for early, mid, late stance phase, the single leg squat and single leg step down task and will be expressed as % of the bodyweight (BW). The differences between the baseline measurements and the measurements after 6 weeks of treatments will be investigated in participants with PFP.
Measured: 6 weeks
Maximal hip adduction angle
The maximal hip adduction angle will be given for the early, mid, late stance phase, the single leg squat and single leg step down task and will be expressed in degrees. The differences between the baseline measurements and the measurements after 6 weeks of treatments will be investigated in participants with PFP.
Measured: 6 weeks
Maximal hip adduction moment
The maximal hip adductor moment will be given as % of the bodyweight (BW). The maximal hip adductor moment will be investigated for early, mid, late stance phase, the single leg squat and single leg step down task and will be expressed as % of the bodyweight (BW). The differences between the baseline measurements and the measurements after 6 weeks of treatments will be investigated in participants with PFP.
Measured: 6 weeks
Maximal hip internal rotation
The maximal hip internal rotation angle will be given for the early, mid, late stance phase, the single leg squat and single leg step down task and will be expressed in degrees. The differences between the baseline measurements and the measurements after 6 weeks of treatments will be investigated in participants with PFP.
Measured: 6 weeks
Maximal hip internal moment
The maximal hip internal rotation moment will be given as % of the bodyweight (BW). The maximal hip internal rotation moment will be investigated for early, mid, late stance phase, the single leg squat and single leg step down task and will be expressed as % of the bodyweight (BW). The differences between the baseline measurements and the measurements after 6 weeks of treatments will be investigated in participants with PFP.
Measured: 6 weeks
Secondary outcomes (11)
temporo-spatial parameters: speed
The gait speed will be analysed and expressed as mean and SD.
Measured: 6 weeks
temporo-spatial parameters: step length
The step length will be analysed and expressed as mean and SD.
Measured: 6 weeks
Muscle strength: peak strength during the eccentric quadriceps task
The peak strength will be measured during the eccentric quadriceps testing (Kin Com).
Measured: 6 weeks
Muscle strength: peak strength during the isometric quadriceps task
The peak strength will be measured during the isometric quadriceps testing (Kin Com).
Measured: 6 weeks
KOOS, AKPS, Tampa scale questionnaires
Only patients with PFP will be asked to fill them. For each of the questionnaires a normalized score will be calculated for each subscale. The differences of the overall score will be calculated to ensure that confounding factors, such as kinesiophobia are controlled and checked.
Measured: 6 weeks
Foot posture
The results of the 6-item foot posture index will be summarised, whereby a negative result expresses a supinated and a positive result a pronated foot.
Measured: 6 weeks
Lateral/ medial displacement of the patella
The lateral/ medial displacement of the patella will be measured and expressed in cm.
Measured: 6 weeks
Lateral/ medial tilt of the patella
The lateral/ medial tilt of the patella will be measured and on a scale from -2 (strongly laterally tilted) to 2 (strongly medially tilted)
Measured: 6 weeks
Flexibility of the quadriceps
The quadriceps flexibility will be assessed by using the modified Thomas test and will be expressed in degrees of the knee flexion.
Measured: 6 weeks
Flexibility of the hamstrings
The hamstrings flexibility will be assessed by using the active knee extension test and will be expressed in degrees of the knee flexion.
Measured: 6 weeks
Flexibility of the ankle range of motion.
The ankle flexibility will be assessed by using the weight bearing lunge test and will be expressed in degrees of the ankle dorsalflexion and in cm, by measuring the distance of the 1st toe to the wall.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2016 (estimated)
- Study startJun 2016
- Primary completionSep 2017 (estimated)
- Study completionOct 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PFPStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Salford
- Sponsor type
- University, hospital or other
- Collaborators
- Northern Care Alliance NHS Foundation Trust
- Responsible party
- Principal investigator, Henrike Greuel, University of Salford
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02786784
- Sponsor's protocol ID
- IRAS 194530
- Acronym
- PFP-Inhibit
- Status last verified
- Sep 2016
- First submitted
- 23 May 2016
- Last updated
- 26 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Arthrogenic Muscular Inhibition in Patellofemoral Pain and the Response to an Exercise Programme
- ClinicalTrials.gov ID
- NCT02786784
- Acronym / sponsor ID
- PFP-Inhibit / IRAS 194530
- Conditions
- PFP, Patellofemoral Pain, Anterior Knee Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of SalfordUniversity, hospital or other
- Collaborators
- Northern Care Alliance NHS Foundation Trust
- Study start
- Jun 2016
- Primary completion
- Sep 2017 (estimated)
- Study completion
- Oct 2017 (estimated)
- First posted
- 1 Jun 2016 (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 (PFP) is the most diagnosed condition in individuals with knee complaints. Studies revealed that one third of individuals with PFP suffer from persistent complaints, indicating that current treatments fail to prevent the chronicity of symptoms. Considering that current treatment-strategies of patients with PFP seem to be unable to avoid the development of chronic symptoms, the question arises if the underlying factors of PFP are understood sufficiently. Current research focuses predominantly on muscle strength assessment by means of a maximum voluntary contraction (MVC), even though, weakness might not only be caused by a reduced voluntary contraction but also by an involuntary ability to contract the muscle fully, which is named arthrogenous muscular inhibition (AMI). Although AMI has been proven to be present in a wide range of knee joint pathologies to date it remains unclear whether patients with PFP are weak or inhibited. It remains also unclear if there exists a causal link between AMI and biomechanical alterations.
Previous studies investigated the influence of exercise treatment on muscular strength, function and pain. However, to date no study investigated the influence of the currently recommended exercise treatment on AMI. Thus, the analysis of the effect of a 6 week exercise treatment might yield further insights if a specific exercise treatment can reduce AMI, improve functional performance and reduce pain.
Methods: The investigators will invite 40 participants with PFP and 40 healthy controls to take part in the study. As a basis investigation kinematic, kinetic measures, and surface electromyographic (sEMG) of 4 lower limb muscles will be taken during functional tasks. Muscle strength and AMI of the quadriceps, muscle flexibility, and a posture assessment of the patella as well as the foot will be carried out. All participants with PFP will then receive a 6 week exercise programme to follow. After six weeks, the participants with PFP will attend the Salford university, where they will be reassessed.
Expected outcomes: The study will investigate if AMI is present in participants with PFP and if AMI is directly linked to functional performance. In addition this study will investigate if a specific exercise treatment can reduce AMI and improve functional performance.
Detailed description
Procedures The testing will be performed in the human performance laboratory at the University of Salford, Manchester. Upon arrival at the laboratory, the participants will be briefed through the study and the objectives of the investigations and the study equipment will be explained to them. They will be asked to sign the informed consent form, a health history questionnaire. The health history questionnaire consists of 13 questions investigating potential risks associated with the study.
The individual will then be asked to change into their shorts and a comfortable t-shirt.
Strength and arthrogenic muscle inhibition:
The muscular inhibition of the quadriceps will be assessed, during a maximal isometric contraction (MVIC) of the quadriceps with the interpolated twitch technique. The participants will perform 5 times a maximal contraction of their knee extensor and additional electrical stimulation will be applied, which will be performed on an isokinetic dynamometer (Kin-Com) with a knee flexion angle of 90°. Then the participant will be asked to perform 5 times an eccentric quadriceps contraction at the angular velocity of 60 degrees/ second, through the full available range of motion (ROM) from 90 degrees knee flexion to maximum knee extension, while the quadriceps torque will be measured.
Questionnaires:
The participants with PFP will then be asked to fill in 3 different questionnaires:
the KOOS, the AKPS/ Kujala score, and the Tampa Scale of Kinesiophobia.
After this recovery break, the posture and flexibility investigation will be executed. The examination of the foot posture will be performed by using the 6-item foot posture index (FPI-6). The patella alignment includes a lateral - medial displacement/ lateral -medial tilt), and a lateral-medial displacement assessment.
Flexibility:
The flexibility of the hamstrings and the soleus muscle will be assessed.
Biomechanics:
Following this, the researcher will attach 40 retro-reflective markers to the skin of the lower limb on both legs and attach surface electromyographic electrodes to four muscles as in figure 4 on both legs. The electrode placement will be performed according to the SENIAM guidelines. Suface EMG (sEMG) data will be collected of vastus medialis, vastus lateralis, biceps femoris and semitendinosus will be synchronised with the motion capture system on Qualisys.
After a static 3-dimensional image from ten infra-red cameras will be obtained. The 3D kinematics of the ankle, knee, and hip joint and ground reaction forces (GRF) will be recorded for each participant during a running, a single leg squat and a step down task.
Treatment:
The 6 week treatment will be exclusively conducted by physiotherapists at the Salford Royal Hospital (Salford Royal NHS Foundation Trust, SRFT).
Physiotherapist from the Salford Royal hospital will introduce the treatment programme to the participants. Additionally, each participants will receive a booklet with a detailed description of the treatment programme, as well as access to a password protected website (VIMEO) to watch the videos of all exercises.
Assessment of the treatment outcomes after 6 weeks At the end of the 6 weeks exercise intervention, the participants with PFP will then attend the human performance laboratory at the University of Salford. The muscle strength, AMI, flexibility, posture assessment, as well as the clinical assessment of running and a step down task of each individual will be measured to investigate the change in AMI and functional performance due to the treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| healthy control | Other | Other: 6 week exercise treatmentpatients with patellofemoral pain |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Reproducible pain with at least two of these activities: ascending or descending stairs or ramps, squatting, kneeling, prolonged sitting, hopping/ jumping, isometric quadriceps contraction or running
- Clearly defined pain location in the peripatellar region
- Reports of pain greater than 1 month duration.
- They are able to perform squatting, running and MVC task- Participant response
- Age range: 18-45 years old
Key exclusion criteria (8 listed)
- Previous history of knee surgery
- Previous history of (traumatic) patella dislocation or instability
- Previous history of ligamentous instabilities
- Previous history of traumatic, inflammatory or infectious pathology in the lower extremity
- Previous history of internal derangement or other causes
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 |
|---|---|---|
| 6 week exercise treatmentThis six-week exercise programme was developed based on the current recommendations, consisting of four exercises to strengthen gluteus medius and maximus muscle, as well as the quadriceps muscle. In addition, two exercises to stretch the hamstrings muscles and to increase the ankle dorsi range of motion were included. | Other | healthy control |
Primary outcome
Extent of the arthrogenic muscle inhibition (AMI)
Time frame: 6 weeks
AMI will be calculated from the ratio: AMI = (resting twitch size in Nm/ twitch size during MVC in Nm)*100 AMI will be expressed in %. The differences between the baseline measurements and the measurements after 6 weeks of treatments will be investigated in participants with PFP.
quadriceps/ hamstrings cocontraction
Time frame: 6 weeks
The cocontraction of the quadriceps (vastus medialis and lateralis) and the hamstring (biceps femoris and semitendinosus) was calculated by the formula developed by Heiden et al. 2009, whereby 0 expresses no cocontraction and 1 a complete cocontraction. The cocontraction will be calculated for for the early, mid, late stance phase, the single leg squat and single leg step down task. Differences between the baseline of participants with PFP and after 6 weeks after the treatment will be investigated. Furthermore, the correlation between the external knee adduction moment (EKAM) to AMI will be investigated.
Presence of the break phenomenon
Time frame: 6 weeks
The break phenomenon is defined as a trace dip during the eccentric quadriceps phase, which exceeds more than 10% of the pre-break moment. The break phenomenon will be defined as either: present or not present. The differences between the baseline measurements and the measurements after 6 weeks of treatments will be investigated in participants with PFP.
Maximal knee adduction angle
Time frame: 6 weeks
The maximal knee adduction angle will be given for the early, mid, late stance phase, the single leg squat and single leg step down task and will be expressed in degrees. The differences between the baseline measurements and the measurements after 6 weeks of treatments will be investigated in participants with PFP.
Maximal knee adductor moment (EKAM)
Time frame: 6 weeks
The maximal knee adductor moment will be given as % of the bodyweight (BW). The maximal EKAM will be investigated for early, mid, late stance phase, the single leg squat and single leg step down task. The differences between the baseline measurements and the measurements after 6 weeks of treatments will be investigated in participants with PFP.
the knee adduction angular impulse (KAAI)
Time frame: 6 weeks
knee adduction angular impulse is defined as the integral of the knee adduction moment-time curve. The normalised KAAI will be given as % of the bodyweight (BW). The KAAI will be given for early, mid, late stance phase, the single leg squat and single leg step down task. The differences between the baseline measurements and the measurements after 6 weeks of treatments will be investigated in participants with PFP.
Maximal knee internal rotation
Time frame: 6 weeks
The maximal knee internal rotation angle will be given for the early, mid, late stance phase, the single leg squat and single leg step down task and will be expressed in degrees. The differences between the baseline measurements and the measurements after 6 weeks of treatments will be investigated in participants with PFP.
Maximal knee internal rotation moment
Time frame: 6 weeks
The maximal knee internal rotation moment will be given as % of the bodyweight (BW). The maximal knee internal rotation moment will be investigated for early, mid, late stance phase, the single leg squat and single leg step down task and will be expressed as % of the bodyweight (BW). The differences between the baseline measurements and the measurements after 6 weeks of treatments will be investigated in participants with PFP.
Maximal hip adduction angle
Time frame: 6 weeks
The maximal hip adduction angle will be given for the early, mid, late stance phase, the single leg squat and single leg step down task and will be expressed in degrees. The differences between the baseline measurements and the measurements after 6 weeks of treatments will be investigated in participants with PFP.
Maximal hip adduction moment
Time frame: 6 weeks
The maximal hip adductor moment will be given as % of the bodyweight (BW). The maximal hip adductor moment will be investigated for early, mid, late stance phase, the single leg squat and single leg step down task and will be expressed as % of the bodyweight (BW). The differences between the baseline measurements and the measurements after 6 weeks of treatments will be investigated in participants with PFP.
Maximal hip internal rotation
Time frame: 6 weeks
The maximal hip internal rotation angle will be given for the early, mid, late stance phase, the single leg squat and single leg step down task and will be expressed in degrees. The differences between the baseline measurements and the measurements after 6 weeks of treatments will be investigated in participants with PFP.
Maximal hip internal moment
Time frame: 6 weeks
The maximal hip internal rotation moment will be given as % of the bodyweight (BW). The maximal hip internal rotation moment will be investigated for early, mid, late stance phase, the single leg squat and single leg step down task and will be expressed as % of the bodyweight (BW). The differences between the baseline measurements and the measurements after 6 weeks of treatments will be investigated in participants with PFP.
11 secondary outcomes
temporo-spatial parameters: speed
Time frame: 6 weeks
temporo-spatial parameters: step length
Time frame: 6 weeks
Muscle strength: peak strength during the eccentric quadriceps task
Time frame: 6 weeks
Muscle strength: peak strength during the isometric quadriceps task
Time frame: 6 weeks
KOOS, AKPS, Tampa scale questionnaires
Time frame: 6 weeks
Foot posture
Time frame: 6 weeks
Lateral/ medial displacement of the patella
Time frame: 6 weeks
Lateral/ medial tilt of the patella
Time frame: 6 weeks
Flexibility of the quadriceps
Time frame: 6 weeks
Flexibility of the hamstrings
Time frame: 6 weeks
Flexibility of the ankle range of motion.
Time frame: 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2016.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 6 week exercise treatment in people with PFP and Patellofemoral Pain, run by University of Salford at 1 site in United Kingdom.
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 7 inclusion and 8 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 26 Sep 2016. 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 United Kingdom. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Henrike Greuel, MSc (0161 2952017, H.Greuel@edu.salford.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Extent of the arthrogenic muscle inhibition (AMI) (time frame: 6 weeks). The study lists 12 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 26 Sep 2016.