Knee Pressure Stimuli on Quadriceps Strength in Knee Osteoarthritis

Effects of Joint Pressure Stimuli on Quadriceps Strength and Neuromuscular Activity in Patients With Knee Ostearthritis

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Knee Osteoarthritis; Muscle Weakness
• Intervention / Treatment: Device: Periarticular compression

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 Type: Observational
• Enrollment (Anticipated): 50

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• 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".

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients with knee osteoarthritis; Periarticular knee compression using a sphygmomanometer.	Device: Periarticular compression; Periarticular knee compression using a sphygmomanometer.
Healthy subjects; Periarticular knee compression using a sphygmomanometer.	Device: Periarticular compression; Periarticular knee compression using a sphygmomanometer.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Istituto Clinico Humanitas

Study record dates

Study Major Dates

• Study Start (Anticipated): April 15, 2023
• Primary Completion (Anticipated): June 1, 2023
• Study Completion (Anticipated): September 1, 2023

Study Registration Dates

• First Submitted: April 7, 2023
• First Submitted That Met QC Criteria: April 20, 2023
• First Posted (Actual): April 24, 2023

Study Record Updates

• Last Update Posted (Actual): April 24, 2023
• Last Update Submitted That Met QC Criteria: April 20, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Neurologic Manifestations; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Muscular Diseases; Neuromuscular Manifestations; Osteoarthritis; Osteoarthritis, Knee; Muscle Weakness
• Other Study ID Numbers: CLF22/05

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No