NCT02734030

Brief Summary

This study aims to compare the knee extensors' mechanical, morphological and myoelectric properties between subjects affected by anterior knee pain and a healthy control group. The investigators hypothesis is that patients with anterior knee pain present a reduction in the knee extensors' mechanical, morphological and myoelectric properties due to chronic muscle inhibition produced by the syndrome. In addition, the study also aims to evaluate whether there are differences in methodology for application of the Interpolated Twitch Technique for evaluation of the quadriceps muscle inhibition by comparing the use of supramaximal electrical stimulation on the femoral nerve (gold standard) with stimulation on the motor point (new methodology) in healthy subjects and individuals affected by anterior knee pain. The investigators hypothesis is that the stimulation on the motor point is less discomfortable than on the femoral nerve and muscle inhibition results are less variable (with lower dispersion) due to such lower discomfort

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2015

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

January 26, 2016

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 12, 2016

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
Last Updated

October 26, 2017

Status Verified

October 1, 2017

Enrollment Period

11 months

First QC Date

January 26, 2016

Last Update Submit

October 24, 2017

Conditions

Keywords

Anterior Knee Pain SyndromeQuadriceps FemorisMuscle InhibitionInterpolated Twitch TechniqueMuscle ArchitectureSingle Leg SquatWomen Knee Pain

Outcome Measures

Primary Outcomes (6)

  • Torque

    Torque is an expression of the muscular strength and was assessed by dynamometry.

    Torque was measured during a single visit to the laboratory during the study.The evaluation was performed up to 5 months

  • Muscular architecture

    Muscular architecture (muscle thickness, pennation angle and fascicle length) was assessed by ultrasonography

    Muscle architecture was measured one time during the study. The evaluation was performed up to 5 months

  • Muscle inhibition

    Quadriceps muscle inhibition was assessed using the Interpolated Twitch Technique comparing the use of supramaximal electrical stimulation on the femoral nerve (gold standard) with stimulation on the motor point (new methodology).

    Muscle inhibition was measured during a single visit to the laboratory during the study. The evaluation was performed up to 5 months

  • Muscular electrical activation

    Electrical activation was assessed by surface electromyography (EMG)

    Muscular electrical activation was measured during a single visit to the laboratory during the study. The evaluation was performed up to 5 months

  • Patellofemoral cartilage thickness

    Patellofemoral cartilage thickness were assessed by ultrasonography

    Patellofemoral cartilage thickness was measured one time during the study. The evaluation was performed up to 5 months

  • Single Leg Squat

    Single leg squat was measured with a video camera and allowed to determine lower limb functionality

    Single leg squat performance was measured one time during the study. The evaluation was performed up to 5 months

Secondary Outcomes (1)

  • Knee pain

    Knee pain during the tests was measured after all knee extensor contractions. The evaluation was performed up to 5 months.

Study Arms (2)

Control Group

Knee pain-free females with no history of lower limb injuries serving as a control group. .

Anterior Knee Pain Group

Females with anterior knee pain syndrome were enrolled in this group.

Eligibility Criteria

Age20 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Young women symptomatic and assymptomatic for anterior knee pain syndrome

You may qualify if:

  • Anterior Knee pain group:
  • Retropatellar or peripatellar knee pain in at least 2 of the following functional activities: stair ascent or descent, running, kneeling, squatting, prolonged sitting, jumping;
  • Score smaller than 85 points on the Kujala Questionnaire;
  • Physically active according to the International Physical Activity Questionnaire (IPAQ - short version)
  • Body mass index less than 30
  • Control group:
  • Knee pain-free females with no history of lower limb injuries

You may not qualify if:

  • Body mass index higher than 30
  • Sedentary subjects
  • Cardiovascular, neurological or cognitive disorders
  • Any cardiorespiratory, neuromuscular, or metabolic disease that could represent an absolute contraindication or a contraindication to the performance of maximum strength tests
  • Previous surgery on lower limb
  • Participation in a strength-training programme or physiotherapy treatment for knee injuries in the past six months
  • Otherwise associated injury in the lower limb joints other than anterior knee pain syndrome
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Exercise Research Laboratory, School of Physical Education, Federal University of Rio Grande do Sul

Porto Alegre, Rio Grande do Sul, 90690-200, Brazil

Location

MeSH Terms

Conditions

Patellofemoral Pain Syndrome

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal Diseases

Study Officials

  • Marco Vaz, PhD

    Federal University of Rio Grande do Sul

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

January 26, 2016

First Posted

April 12, 2016

Study Start

April 1, 2015

Primary Completion

March 1, 2016

Study Completion

October 1, 2016

Last Updated

October 26, 2017

Record last verified: 2017-10

Data Sharing

IPD Sharing
Will not share

Locations