ClinicalTrials.gg
Not yet recruitingNCT06319937Updated Mar 20, 2024

Muscle Architecture in Knee Osteoarthritis

An interventional study of Ultrasound in Knee Osteoarthritis, Foot Deformities and Muscle Weakness, sponsored by Hacettepe University. Not yet recruiting. Open to female participants aged 45 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-03-20.

Sponsored by Hacettepe University · Not applicable, Interventional, and Diagnostic

From the registry’s dates

  • Primary completion was expected by Jun 2024, 2 years 5 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Not applicable
Ages
45 Years to 65 Years
Sex
Female
01

Study summary

Background: The aim of this study was to compare the knee and ankle muscle architecture and plantar pressure distribution differences in knee osteoarthritis (OA) women with healthy women.

Methods: Fifty women with knee OA (Mean age=52.11±4.96 years, mean BMI=30.94±4.23 kg/m2) and fifty healthy women (Mean age= 50.93±3.78 years, mean BMI=29.06±4.82 kg/m2) were included in the study. Ultrasonography was used to evaluate Rectus Femoris (RF), Vastus Medialis (VM), Vastus Lateralis (VL), Peroneus Longus (PL), Tibialis Anterior (TA), and Medial Gastrocnemius (MG) muscle thickness, pennation angle, fascicle length, and fat thickness. The plantar pressure distribution was evaluated using the Digital Biometry Scanning System and software (DIASU, Italy).

Read the detailed description

The following measurements were performed in subjects with knee osteoarthritis and healthy subjects with similar age-BMI and then a comparison was made between the 2 groups.

Measurements Pain severity: The Visual Analogue Scale (VAS) was used to assess the severity of knee and foot pain during activity. The 10-cm horizontal line was defined as 0 "no pain" and 10 "very severe pain", and the patients were asked to indicate their knee and foot pain level by drawing a line. This line was then measured in centimeters on both the dominant and non-dominant side.

Static foot posture: The Foot Posture Index (FPI) was used to evaluate foot posture in a relaxed position while standing. The FPI is showed to be a valid and reliable tool in individuals with knee OA. The FPI consisted of six items: 1) palpation of the talar head, 2) assessment of the curvature of the supra and infra lateral malleolus, 3) evaluation of the frontal plane position of the calcaneus, 4) identification of any prominence in the region of the talonavicular joint, 5) examination of the congruence of the medial longitudinal arch, and 6) measurement of abduction/adduction of the forefoot on the rear foot. Each item was scored from -2 to +2, and the total score ranged from -12 to +12. A higher positive score indicated a more pronated foot. A score of ≥6 indicated a pronated foot type, while scores of 0-5 indicated a neutral foot type, and scores of ≤-1 indicated a supinated foot type. OA side and dominant side assessed. All data on static foot posture were collected by the physiotherapist who has 5 years of experience in foot assessment (X). To avoid bias, the physiotherapist performing the assessment did not know which group the individuals were in.

Muscle architecture: Ultrasound, which is a measurement method with validity and reliability in individuals with knee OA, was used to evaluate the knee and ankle muscles. A total of six muscles were evaluated, including three knee muscles and three ankle muscles: Rectus Femoris (RF), Vastus Medialis (VM), Vastus Lateralis (VL), Tibialis Anterior (TA), Peroneus Longus (PL) and Medial Gastrocnemius (MG). The muscle thickness, pennation angle, fascicle length and fat thickness of each muscle were evaluated using B-Mode ultrasonography (E-Saote MyLab X8 eXP Ultrasound System, Florence, Italy) and a linear array transducer (4-11.4 MHz). It has been mentioned that there is muscle weakness in the muscles around the knee in knee OA, and in line with the investigators' hypothesis, the investigators thought that there may be differences in the muscles around the foot in these patients, so the investigators preferred to evaluate these muscles. All data on muscle architecture were collected by the same rheumatologist who has 5 years of experience in ultrasound assessment.

The images of the RF, VM, VL, and TA muscles were obtained with participants in a supine position. For the MG and PL muscle images, participants were instructed to lie prone. To enhance reproducibility and minimize the risk of sampling a muscle obliquely, the transducer was oriented parallel to the muscle fascicles and perpendicular to the skin.

The image was regarded as optimized when a thin layer of gel was visible between the skin and the transducer, signifying that no manual compressive forces were distorting the muscle after it had been identified. The same researcher then slightly retracted the transducer to avoid compressing the muscle. Ultrasound images were analyzed using Image J program (Version 1.53p, 2022, National Institutes of Health, Bethesda, MD, USA) by the same researcher. The same procedure was employed for each muscle group, with measurements taken of both muscle architecture and fat thickness. Following completion of all images from the first extremity, the identical technique was utilized to image the opposite lower extremity. Muscle thickness was measured as the distance between the internal borders of the superficial and deep aponeuroses. Fat thickness of all muscles was measured as the distance between the skin of the superficial aponeuroses. Pennation angle was defined as the angle between the muscle fascicle line and the deep aponeuroses. Fascicle length was defined as the distance between the origin of the fascicle at the superficial aponeuroses and insertion of the same fascicle in the deep aponeuroses.

Femoral cartilage thickness: In order to determine femoral cartilage thickness, individuals assumed a supine position with their knees comfortably flexed to the maximum extent. The probe was positioned axially on the suprapatellar region. Femoral cartilage thickness was assessed at three discrete points on both knees, specifically at the levels of the lateral condyle, intercondylar area, and medial condyle. Water-soluble gel was applied between the transducer and the skin to support acoustic coupling, without applying pressure to the muscle. The transducer was oriented axially above the patellar outer edge. In addition, femoral cartilage thickness measurement is a valid and reliable measurement.

Plantar pressure distribution: Plantar pressure distribution was performed by the Digital Biometric Images Scanning System and relevant Milletrix software (Diagnostic Support; Diasu Health Technologies, Rome, Italy). The platform employed in this study comprised a 5-meter long and 40-centimeter wide walkway equipped with 4024 sensors that could sample data at a frequency of 300 MHz. The force platform assessed plantar pressure on both feet while standing, and it calculated the average percentage of pressure distribution for each foot. Participants were instructed to stand barefoot on the platform for 10 seconds, facing a reference point, with their arms hanging comfortably by their sides. During these measurements, the patients were instructed not to consciously adjust their posture.

The static evaluation provided information on numerical surface and loading values, both globally (for each foot) and partially (relative to the rearfoot, forefoot, medial and lateral load). The maximum foot pressure (FPmax), average foot pressure (Pavg.), total surface area, forefoot load (FFL), rearfoot load (RFL), total load on the foot, medial load, lateral load, foot angle (FA) and foot progression angle (FPA) of the women were recorded. Foot angle is the angle between the direction of progression of the individual and a reference line on the sole of each foot. Foot progression angle is the angle between the longitudinal foot axis and the vertical axis of the foot. The plantar pressure distribution outcomes of the related knee in patients with unilateral involvement and the most symptomatic knee in patients with bilateral knee involvement were compared with matched knees of the healthy controls . To ensure blinding in the study, plantar pressure distribution was performed by a physiotherapist with 7 years of experience in this field. To avoid bias, the physiotherapist performing the assessment did not know which group the individuals were in.

Kinesiophobia: The Tampa Kinesiophobia Scale (TKS) was used to assess fear of movement-related pain. This scale, consisting of twenty-three items, assesses the inhibition or fear of movement due to feelings of vulnerability caused by painful conditions. The total score ranges from 17 to 68 points. A high score on the scale indicates a high level of kinesiophobia.

Functional Performance : Functional performance was assessed using the stair-climbing test (SCT) and the 10-time sit-stand test (SST), which were approved for use in individuals with KOA and recommended by the International Osteoarthritis Research Association. For the SCT, individuals were asked to ascend, turn around, and descend a flight of 10 steps as quickly as possible, using one handrail if necessary. The time to ascend and descend was measured. For the SST, individuals were asked to stand up completely straight from a chair with armrests, and sit down again without support from their arms, and repeat this 10 times at the fastest pace they could. The time during this procedure was recorded.

02

Conditions studied

  • Knee Osteoarthritis
  • Foot Deformities
  • Muscle Weakness
  • Kinesiophobia

Keywords

  • knee osteoarthritis
  • ultrasonography
  • kinesiophobia
  • functional performance
  • muscles
  • foot
03

In context

Osteoarthritis, Knee

3,292 studies on the registry are indexed under Osteoarthritis, Knee; 623 are open to participants now.

This study's planned enrollment of 50 is below the median of 68 across 2,714 interventional studies indexed under Osteoarthritis, Knee.

Browse Osteoarthritis, Knee studies →

Lead sponsor

Hacettepe University is the lead sponsor of 1,007 studies on the registry; 214 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
45 Years to 65 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Aged 45-65 years
  • Activity-related knee pain
  • Morning knee stiffness for 30 min
  • Knee pain on most days for 3 months or more

Exclusion criteria

Exclusion Criteria:

  • Having lower extremity surgery
  • Conditions that cause congenital or developmental diseases
  • The presence of systemic inflammatory arthritis
  • Polyneuropathy/lower extremity neuropathy, severe radiculopathy
  • Having undergone physical therapy, exercises or knee injections for the knee in the previous 6 months
  • Congenital foot deformity
  • higher than 35 kg/m2
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
50 participants (estimated)

Study arms

  • Experimental
    OA Group

    Knee OA were included in the study. All patients exhibited evident radiographic changes in either unilateral or bilateral knees, consistent with a diagnosis of osteoarthritis, and were classified as Kellgren Lawrence (K-L) grade 2.

    Diagnostic Test: Ultrasound

Interventions

  • Diagnostic testUltrasound

    Ultrasound

06

What researchers measure

Primary outcomes

  1. Muscle thickness

    Muscle thickness of Rectus Femoris, Vastus Medialis, Vastus Lateralis, Medial Gastrocnemius, Peronalis Longus. Muscle thickness of Rectus Femoris, Vastus Medialis, Vastus Lateralis, Medial Gastrocnemius, Peronalis Longus. Ultrasound, which is a measurement method with validity and reliability in individuals with knee OA, was used to evaluate the knee and ankle muscles. A total of six muscles were evaluated, including three knee muscles and three ankle muscles: Rectus Femoris (RF), Vastus Medialis (VM), Vastus Lateralis (VL), Tibialis Anterior (TA), Peroneus Longus (PL) and Medial Gastrocnemius (MG). The muscle thickness of each muscle were evaluated using B-Mode ultrasonography (Esaote MyLab X8 eXP Ultrasound System, Florence, Italy) and a linear array transducer (4-11.4 MHz)

    Time frame: 15 days

  2. Pennation angle

    Pennation angle of Rectus Femoris, Vastus Medialis, Vastus Lateralis, Medial Gastrocnemius, Peronalis Longus. Ultrasound, which is a measurement method with validity and reliability in individuals with knee OA, was used to evaluate the knee and ankle muscles. A total of six muscles were evaluated, including three knee muscles and three ankle muscles: Rectus Femoris (RF), Vastus Medialis (VM), Vastus Lateralis (VL), Tibialis Anterior (TA), Peroneus Longus (PL) and Medial Gastrocnemius (MG). The pennation angle of each muscle were evaluated using B-Mode ultrasonography (Esaote MyLab X8 eXP Ultrasound System, Florence, Italy) and a linear array transducer (4-11.4 MHz)

    Time frame: 15 days

  3. Fat thickness

    Fat thickness of Rectus Femoris, Vastus Medialis, Vastus Lateralis, Medial Gastrocnemius, Peronalis Longus. Ultrasound, which is a measurement method with validity and reliability in individuals with knee OA, was used to evaluate the knee and ankle muscles. A total of six muscles were evaluated, including three knee muscles and three ankle muscles: Rectus Femoris (RF), Vastus Medialis (VM), Vastus Lateralis (VL), Tibialis Anterior (TA), Peroneus Longus (PL) and Medial Gastrocnemius (MG). The fat thickness of each muscle were evaluated using B-Mode ultrasonography (Esaote MyLab X8 eXP Ultrasound System, Florence, Italy) and a linear array transducer (4-11.4 MHz)

    Time frame: 15 days

Secondary outcomes

  1. Stair climbing test

    Functional performance was assessed using the stair-climbing test (SCT) time which were approved for use in individuals with KOA and recommended by the International Osteoarthritis Research Association. For the SCT, individuals were asked to ascend, turn around, and descend a flight of 10 steps as quickly as possible, using one handrail if necessary. The time to ascend and descend was measured.

    Time frame: 15 days

  2. Sit-stand test

    Functional performance was assessed using the 10-time sit-stand test (SST), which were approved for use in individuals with KOA and recommended by the International Osteoarthritis Research Association. For the SST, individuals were asked to stand up completely straight from a chair with armrests, and sit down again without support from their arms, and repeat this 10 times at the fastest pace they could. The time during this procedure was recorded.

    Time frame: 15 days

07

Study locations

No study locations are listed for this record.

08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Apr 2024; primary completion for Jun 2024, 2 months later.

Of 1,111 non-industry interventional studies with no phase under Osteoarthritis, Knee, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 36. This study's planned 2 months is below that.

Counting every sponsor, half of 1,251 studies reached it within 18 months; a quarter within 8 and three quarters within 36.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 26, 2024
First posted
Mar 20, 2024
StartEst.
Apr 1, 2024
Primary completionEst.
Jun 1, 2024
CompletionEst.
Sep 1, 2025
Last update
Mar 20, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 20, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06319937
Responsible party
HANDE GUNEY (PT, PhD, Prof., Hacettepe University) — Principal investigator
First posted
Mar 20, 2024
Start date
Apr 1, 2024 (estimated)
Primary completion
Jun 1, 2024 (estimated)
Completion
Sep 1, 2025 (estimated)
Last update
Mar 20, 2024

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.

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