Anterior Knee Pain SyndromeNCT02734030
Knee Extensor Muscle Properties in Young Women Symptomatic and Asymptomatic for Anterior Knee Pain
An observational study of Anterior Knee Pain Syndrome, run by Federal University of Rio Grande do Sul at 1 site in Brazil.
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… Read more about this study
- Who is it for?
- Ages 20 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Anterior Knee Pain Syndrome
- How many people
- 32 participants
- Where
- 1 siteBrazil
- Study dates
- Apr 2015to Oct 2016
- Phase
- Observational
- 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 20 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Young women symptomatic and assymptomatic for anterior knee pain syndrome
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Exercise Research Laboratory, School of Physical Education, Federal University of Rio Grande do Sul
Porto Alegre, Rio Grande do Sul, 90690-200
About this study
Official title: Knee Extensor Muscle Inhibition and Neuromechanical and Morphological Properties in Young Women Symptomatic and Asymptomatic for Anterior Knee Pain
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
Read the detailed 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.
- Conditions
- Anterior Knee Pain Syndrome
- Keywords
- Anterior Knee Pain Syndrome, Quadriceps Femoris, Muscle Inhibition, Interpolated Twitch Technique, Muscle Architecture, Single Leg Squat, Women Knee Pain
- 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Torque
Torque is an expression of the muscular strength and was assessed by dynamometry.
Measured: 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
Measured: 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).
Measured: 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)
Measured: 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
Measured: 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
Measured: 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 was measured with a Visual Analogue Scale
Measured: Knee pain during the tests was measured after all knee extensor contractions. The evaluation was performed up to 5 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2016 (estimated)
- Study startApr 2015
- Primary completionMar 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anterior Knee Pain SyndromeStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of Rio Grande do Sul
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marco Aurélio Vaz, PhD, Federal University of Rio Grande do Sul
- Investigators
- Marco Vaz, PhD, Principal investigator, Federal University of Rio Grande do Sul
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02734030
- Sponsor's protocol ID
- UFRGS - 1.032.452
- Status last verified
- Oct 2017
- First submitted
- 26 Jan 2016
- Last updated
- 26 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Knee Extensor Muscle Inhibition and Neuromechanical and Morphological Properties in Young Women Symptomatic and Asymptomatic for Anterior Knee Pain
- ClinicalTrials.gov ID
- NCT02734030
- Acronym / sponsor ID
- UFRGS - 1.032.452
- Conditions
- Anterior Knee Pain Syndrome
- Keywords
- Anterior Knee Pain Syndrome, Quadriceps Femoris, Muscle Inhibition, Interpolated Twitch Technique, Muscle Architecture, Single Leg Squat, Women Knee Pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Federal University of Rio Grande do SulUniversity, hospital or other
- Study start
- Apr 2015
- Primary completion
- Mar 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 12 Apr 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.
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
Detailed 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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Young women symptomatic and assymptomatic for anterior knee pain syndrome
Key inclusion criteria (7 listed)
- Anterior Knee pain group:
- Control group:
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Torque
Time frame: Torque was measured during a single visit to the laboratory during the study.The evaluation was performed up to 5 months
Torque is an expression of the muscular strength and was assessed by dynamometry.
Muscular architecture
Time frame: Muscle architecture was measured one time during the study. The evaluation was performed up to 5 months
Muscular architecture (muscle thickness, pennation angle and fascicle length) was assessed by ultrasonography
Muscle inhibition
Time frame: Muscle inhibition was measured during a single visit to the laboratory during the study. The evaluation was performed up to 5 months
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).
Muscular electrical activation
Time frame: Muscular electrical activation was measured during a single visit to the laboratory during the study. The evaluation was performed up to 5 months
Electrical activation was assessed by surface electromyography (EMG)
Patellofemoral cartilage thickness
Time frame: Patellofemoral cartilage thickness was measured one time during the study. The evaluation was performed up to 5 months
Patellofemoral cartilage thickness were assessed by ultrasonography
Single Leg Squat
Time frame: Single leg squat performance was measured one time during the study. The evaluation was performed up to 5 months
Single leg squat was measured with a video camera and allowed to determine lower limb functionality
1 secondary outcome
Knee pain
Time frame: Knee pain during the tests was measured after all knee extensor contractions. The evaluation was performed up to 5 months.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2017.
- Individual participant dataSharing planned: No
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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.
Marco Vaz, PhD principal investigator
Federal University of Rio Grande do Sul
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anterior Knee Pain Syndrome, run by Federal University of Rio Grande do Sul at 1 site in Brazil.
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: finished, as of the sponsor's last update on 26 Oct 2017. 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 Brazil. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Torque (time frame: Torque was measured during a single visit to the laboratory during the study.The evaluation was performed up to 5 months). The study lists 6 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 Oct 2017.