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The Role of Arthrogenic Muscular Inhibition in Patellofemoral Pain and the Response to an Exercise Programme (PFP-Inhibit)

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ClinicalTrials.gov Identifier: NCT02786784
Recruitment Status : Unknown
Verified September 2016 by Henrike Greuel, University of Salford.
Recruitment status was:  Recruiting
First Posted : June 1, 2016
Last Update Posted : September 26, 2016
Sponsor:
Collaborator:
Salford Royal NHS Foundation Trust
Information provided by (Responsible Party):
Henrike Greuel, University of Salford

Brief 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. 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.


Condition or disease Intervention/treatment Phase
PFP Patellofemoral Pain Anterior Knee Pain Other: 6 week exercise treatment Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Role of Arthrogenic Muscular Inhibition in Patellofemoral Pain and the Response to an Exercise Programme
Study Start Date : June 2016
Estimated Primary Completion Date : September 2017
Estimated Study Completion Date : October 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
healthy control
patients with patellofemoral pain
Other: 6 week exercise treatment
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.




Primary Outcome Measures :
  1. 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.


  2. 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.


  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.


Secondary Outcome Measures :
  1. temporo-spatial parameters: speed [ Time Frame: 6 weeks ]
    The gait speed will be analysed and expressed as mean and SD.

  2. temporo-spatial parameters: step length [ Time Frame: 6 weeks ]
    The step length will be analysed and expressed as mean and SD.

  3. Muscle strength: peak strength during the eccentric quadriceps task [ Time Frame: 6 weeks ]
    The peak strength will be measured during the eccentric quadriceps testing (Kin Com).

  4. Muscle strength: peak strength during the isometric quadriceps task [ Time Frame: 6 weeks ]
    The peak strength will be measured during the isometric quadriceps testing (Kin Com).

  5. KOOS, AKPS, Tampa scale questionnaires [ Time Frame: 6 weeks ]
    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.

  6. Foot posture [ Time Frame: 6 weeks ]
    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.

  7. Lateral/ medial displacement of the patella [ Time Frame: 6 weeks ]
    The lateral/ medial displacement of the patella will be measured and expressed in cm.

  8. Lateral/ medial tilt of the patella [ Time Frame: 6 weeks ]
    The lateral/ medial tilt of the patella will be measured and on a scale from -2 (strongly laterally tilted) to 2 (strongly medially tilted)

  9. Flexibility of the quadriceps [ Time Frame: 6 weeks ]
    The quadriceps flexibility will be assessed by using the modified Thomas test and will be expressed in degrees of the knee flexion.

  10. Flexibility of the hamstrings [ Time Frame: 6 weeks ]
    The hamstrings flexibility will be assessed by using the active knee extension test and will be expressed in degrees of the knee flexion.

  11. Flexibility of the ankle range of motion. [ Time Frame: 6 weeks ]
    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.



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria for patients with PFP:

  1. 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
  2. Clearly defined pain location in the peripatellar region
  3. Reports of pain greater than 1 month duration.
  4. They are able to perform squatting, running and MVC task- Participant response
  5. Age range: 18-45 years old

Inclusion criteria for healthy volunteers:

  1. Healthy and without any previous lower limb injuries
  2. The participant is able to perform squatting, running and MVC task

Exclusion Criteria for all participants:

  1. Previous history of knee surgery
  2. Previous history of (traumatic) patella dislocation or instability
  3. Previous history of ligamentous instabilities
  4. Previous history of traumatic, inflammatory or infectious pathology in the lower extremity
  5. Previous history of internal derangement or other causes
  6. Previous diagnosed degenerative conditions in the knee
  7. Exclusion if patients cannot perform running, step down, or MVC task.
  8. 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02786784


Contacts
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Contact: Henrike Greuel, MSc 0161 2952017 H.Greuel@edu.salford.ac.uk
Contact: Rich K Jones, PhD 0161060549 r.k.jones@salford.ac.uk

Locations
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United Kingdom
University of Salford Recruiting
Salford, Greater Manchester, United Kingdom, M66PU
Contact: Henrike Greuel, MSc    0161 295 2017    H.Greuel@edu.salford.ac.uk   
Contact: Richard K Jones, PhD    0161 306 0549    R.K.Jones@salford.ac.uk   
Sponsors and Collaborators
University of Salford
Salford Royal NHS Foundation Trust
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Responsible Party: Henrike Greuel, PhD student, Principal Investigator, University of Salford
ClinicalTrials.gov Identifier: NCT02786784    
Other Study ID Numbers: IRAS 194530
First Posted: June 1, 2016    Key Record Dates
Last Update Posted: September 26, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided