Clinical trial NCT05826236: Knee Pressure Stimuli on Quadriceps Strength in Knee Osteoarthritis
Official title: Effects of Joint Pressure Stimuli on Quadriceps Strength and Neuromuscular Activity in Patients With Knee Ostearthritis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Knee Osteoarthritis
Muscle Weakness
Lead sponsor: Istituto Clinico Humanitas
Sponsor class: OTHER
First posted: 2023-04-24
Enrollment: 50
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects with end-stage knee osteoarthritis with the aforementioned eligibility criteria and age-matched healthy subjects with the same criteria except "end-stage knee osteoarthritis".

Brief summary: The study aims at investigating the effects of a periarticular knee pressure stimulation on quadriceps strength and neuromuscular activity in subjects with knee ostearthritis.

Twenty-five patients with end-stage knee osteoarthritis and and twenty-five age-matched healthy subjects will be enrolled. All participants will be asked to performed isometric maximal voluntary knee extension tasks with three different pressure stimuli in terms of intensity (0 mmHg, 60 mmHg, 120 mmHg) around the knee using a sphygmomanometer. Peak force and root-mean-square peak of rectus femoris, vastus medialis, and vastus lateralis will be collected.

Detailed description: The study aimed at assessing the effects of a periarticular pressure stimulation of the knee joint on quadriceps strength and neuromuscular activity in patients with end-stage knee osteoarthritis.

Twenty-five patients with end-stage knee osteoarthritis and and twenty-five age-matched healthy subjects will be enrolled. Participants will seat on a dynamometer chair (BAR, OTBioelettronica, Italy) with hips and knees at 90 degrees and 30 degrees of flexion, respectively. Participants will perform six maximal voluntary knee extension tasks with three different pressure stimuli in terms of intensity (0 mmHg, 60 mmHg, 120 mmHg) around the knee using a sphygmomanometer. Two maximum voluntary contractions interspaced by 3 minutes of rest will be performed for each pressure level, and the peak force (N) will be collected and normalized for the highest value during the three conditions. Moreover, root-mean-square peak (RMS-peak) of rectus femoris, vastus medialis, and vastus lateralis will be recorded using bipolar surface electromyography electrodes (FREEEMG, BTS, Italy). The RMS-peak of each muscle will be normalized for its highest value among the three conditions (nRMS-peak) and used as index of neuromuscular activity.

Eligibility criteria: Inclusion Criteria:

* End-stage knee osteoarthritis
* Age between 40 and 80 years
* at least 0-90° of knee range of motion along the sagittal plane

Exclusion Criteria:

* Cognitive impairments or psychiatric disorders
* Concomitant neurological, orthopedic, cardiovascular disorders
* Lower limb orthopedic surgery or traumatic events in the previous year

Primary outcomes:
measure: Changes in Peak Force
timeFrame: Baseline (0mmHg), 3 minute after baseline (60mmHg) and 6 minutes after baseline (120mmHg)
Secondary outcomes:
measure: Changes in Root Mean Square peak
timeFrame: Baseline (0mmHg), 3 minute after baseline (60mmHg) and 6 minutes after baseline (120mmHg)
Other outcomes:
Locations:
Study officials:
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