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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02734030
Other study ID # UFRGS - 1.032.452
Secondary ID
Status Completed
Phase N/A
First received January 26, 2016
Last updated October 24, 2017
Start date April 2015
Est. completion date October 2016

Study information

Verified date October 2017
Source Federal University of Rio Grande do Sul
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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


Description:

Participants were divided in two groups (control group, n=16 and anterior knee pain group, n=16). Prior to participation, informed consent was obtained from all subjects. The evaluation was performed at the lower limb with severe symptoms of anterior knee pain in the patients, and at the dominant limb in the control group. Quadriceps Muscle inhibition was estimated using the Interpolated Twitch Technique, which involves applying a single electrical twitch stimulation to the femoral nerve (gold standard) during a maximal isometric knee extensor contraction. Muscle inhibition measurements were obtained with the aid of a Grass S88 (Quincy, MA, USA.) Muscle Stimulator in combination with and isolation unit approved for human use. Isometric and isokinetic knee extensor torques were obtained with a Biodex System 3 dynamometer (Biodex Medical System, Shirley - NY, USA). Electromyographic muscle activity was measured with bipolar surface electrodes (Kendall, Meditrace - 100; Ag/AgCl) that were placed on the muscle bellies of vastus medialis, vastus lateralis and rectus femoris. Muscle architecture was measured with a B-mode ultrasonographic system (SSD; Aloka Inc., Tokyo, Japan) with a linear-array probe (60 mm, 7.5MHz; Aloka). Single Leg Squat was used for clinical evaluation of the lower limb functionality.


Recruitment information / eligibility

Status Completed
Enrollment 32
Est. completion date October 2016
Est. primary completion date March 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 20 Years to 40 Years
Eligibility Inclusion Criteria:

- Anterior Knee pain group:

1. Retropatellar or peripatellar knee pain in at least 2 of the following functional activities: stair ascent or descent, running, kneeling, squatting, prolonged sitting, jumping;

2. Score smaller than 85 points on the Kujala Questionnaire;

3. Physically active according to the International Physical Activity Questionnaire (IPAQ - short version)

4. Body mass index less than 30

- Control group:

1. Knee pain-free females with no history of lower limb injuries

Exclusion Criteria:

1. Body mass index higher than 30

2. Sedentary subjects

3. Cardiovascular, neurological or cognitive disorders

4. Any cardiorespiratory, neuromuscular, or metabolic disease that could represent an absolute contraindication or a contraindication to the performance of maximum strength tests

5. Previous surgery on lower limb

6. Participation in a strength-training programme or physiotherapy treatment for knee injuries in the past six months

7. Otherwise associated injury in the lower limb joints other than anterior knee pain syndrome

8. Pregnancy

Study Design


Locations

Country Name City State
Brazil Exercise Research Laboratory, School of Physical Education, Federal University of Rio Grande do Sul Porto Alegre Rio Grande do Sul

Sponsors (1)

Lead Sponsor Collaborator
Federal University of Rio Grande do Sul

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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 Knee pain Knee pain was measured with a Visual Analogue Scale Knee pain during the tests was measured after all knee extensor contractions. The evaluation was performed up to 5 months.
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