The Role of Arthrogenic Muscular Inhibition in Patellofemoral Pain and the Response to an Exercise Programme

NCT02786784 | Unknown DMC

• 1 other identifier: IRAS 194530
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

PFP; Patellofemoral Pain; Anterior Knee Pain

Outcome Measures

Primary Outcomes (12)

• 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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  6 weeks

Secondary Outcomes (11)

• temporo-spatial parameters: speed

  6 weeks

• temporo-spatial parameters: step length

  6 weeks

• Muscle strength: peak strength during the eccentric quadriceps task

  6 weeks

• Muscle strength: peak strength during the isometric quadriceps task

  6 weeks

• KOOS, AKPS, Tampa scale questionnaires

  6 weeks

Study Arms (1)

healthy control

OTHER

patients with patellofemoral pain

Other: 6 week exercise treatment

Interventions

6 week exercise treatment OTHER

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.

healthy control

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Salford: lead
• Northern Care Alliance NHS Foundation Trust: collaborator

Study Sites (1)

University of Salford

Salford, Greater Manchester, M66PU, United Kingdom

RECRUITING

MeSH Terms

Conditions

Patellofemoral Pain Syndrome

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases

Central Study Contacts

Henrike Greuel, MSc

CONTACT

0161 2952017; H.Greuel@edu.salford.ac.uk

Rich K Jones, PhD

CONTACT

0161060549; r.k.jones@salford.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD student, Principal Investigator

Study Record Dates

• First Submitted: May 23, 2016
• First Posted: June 1, 2016
• Study Start: June 1, 2016
• Primary Completion: September 1, 2017
• Study Completion: October 1, 2017
• Last Updated: September 26, 2016

Record last verified: 2016-09

Locations

GB (1)