Knee Pressure Stimuli on Quadriceps Strength in Knee Osteoarthritis

Not yet recruiting

• Conditions: Knee Osteoarthritis; Muscle Weakness
• Interventions: Device: Periarticular compression

• Registration Number: NCT05826236
• Lead Sponsor: Istituto Clinico Humanitas

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.

Study Timeline

• Status Verified: 2023-04
• Study First Submitted: 2023-04-07
• Study Start: 2023-04-15
• Study First Submitted QC: 2023-04-20
• Last Update Submitted: 2023-04-20
• Study First Posted: 2023-04-24
• Last Update Posted: 2023-04-24
• Primary Completion: 2023-06-01
• Study Completion: 2023-09-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with knee osteoarthritis	Periarticular compression	Periarticular knee compression using a sphygmomanometer.
Healthy subjects	Periarticular compression	Periarticular knee compression using a sphygmomanometer.

Primary Outcome Measures

Name	Time	Method
Changes in Peak Force	Baseline (0mmHg), 3 minute after baseline (60mmHg) and 6 minutes after baseline (120mmHg)	Changes in strength during a maximal voluntary contraction using 0mmHg, 60mmHg or 120mmHg of compression intensity.

Secondary Outcome Measures

Name	Time	Method
Changes in Root Mean Square peak	Baseline (0mmHg), 3 minute after baseline (60mmHg) and 6 minutes after baseline (120mmHg)	Changes in neuromuscular activity during a maximal voluntary contraction using 0mmHg, 60mmHg or 120mmHg of compression intensity.