Knee Pressure Stimuli on Quadriceps Strength in Knee Osteoarthritis

Knee Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05826236
• Other study ID #: CLF22/05
• Status: Not yet recruiting
• Start date: April 15, 2023
• Est. completion date: September 1, 2023

Study information

• Verified date: April 2023
• Source: Istituto Clinico Humanitas
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: September 1, 2023
• Est. primary completion date: June 1, 2023
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Muscle Weakness
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Device:
• Periarticular compression
Periarticular knee compression using a sphygmomanometer.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Clinico Humanitas

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)