Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06502795
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-09
Brief Title:
Quadriceps Strengthening at Different Angles in Patellofemoral Pain
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Quadriceps Strengthening Under Limited Range of Motion Compared to Patient-guided Range of Motion on Pain Kinesiophobia and Function in Individuals With Patellofemoral Pain A Randomized Clinical Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Introduction Patellofemoral pain PFP is characterized by anterior retropatellar andor peripatellar pain during activities such as running squatting kneeling or prolonged sitting This condition affects approximately 25 of the general population Given its complex and multifactorial etiology PFP presents a significant treatment challenge All clinical practice guidelines recommend strengthening the quadriceps femoris muscle as a key component in the management of PFP However exercises aimed at strengthening the quadriceps place considerable stress on the patellofemoral joint and are often poorly tolerated by patients Clinicians commonly employ a conservative strategy that restricts open kinetic chain knee extension exercises to a limited range of 90 to 45 of knee flexion and closed kinetic chain exercises to 0 to 45 Yet restricting the range of motion may result in suboptimal outcomes for patients with higher load tolerance and may foster beliefs regarding knee joint fragility
Objective We aim to compare the effects of quadriceps femoris strengthening within a limited range to a patient-guided range of motion on pain function knee confidence and kinesiophobia in individuals with PFP
Methods A randomized clinical trial will be conducted with two parallel groups using a balanced 11 allocation and a double-blind design The study population will include men and women aged 18 to 35 years diagnosed with PFP Participants will be randomly assigned to either the limited range group or the patient-guided range of motion group They will participate in a supervised therapeutic protocol with sessions averaging 40 minutes twice a week for six consecutive weeks The primary outcome will be pain assessed using the numerical pain rating scale 0-10 and kinesiophobia assessed by the Tampa Scale Secondary outcomes will include pain self-reported function measured by the Anterior Knee Pain Scale AKPS perceived improvement by the Global Rating of Change Scale quadriceps strength kinesiophobia and analgesic consumption
Objective We aim to compare the effects of quadriceps femoris strengthening within a limited range to a patient-guided range of motion on pain function knee confidence and kinesiophobia in individuals with PFP
Methods A randomized clinical trial will be conducted with two parallel groups using a balanced 11 allocation and a double-blind design The study population will include men and women aged 18 to 35 years diagnosed with PFP Participants will be randomly assigned to either the limited range group or the patient-guided range of motion group They will participate in a supervised therapeutic protocol with sessions averaging 40 minutes twice a week for six consecutive weeks The primary outcome will be pain assessed using the numerical pain rating scale 0-10 and kinesiophobia assessed by the Tampa Scale Secondary outcomes will include pain self-reported function measured by the Anterior Knee Pain Scale AKPS perceived improvement by the Global Rating of Change Scale quadriceps strength kinesiophobia and analgesic consumption
Detailed Description:
Participants with patellofemoral pain will be randomized into two intervention groups All participants will start with a warm-up on a stationary bike followed by dynamic stretching exercises targeting the quadriceps hamstrings calf muscles adductors and abductors
Open kinetic chain exercises will be performed using a leg extension machine while closed kinetic chain exercises will include free squats and Bulgarian squats
The Limited-RoM Quadriceps Strengthening group will perform open-kinetic-chain quadriceps strengthening exercises within a range of 90 to 45 of knee flexion and closed-kinetic-chain within a range of 0 to 45
The Patient-Guided-RoM Quadriceps Strengthening group will perform quadriceps strengthening exercises in both open and closed kinetic chains to the maximum tolerated by the patient based on their symptoms The patient-guided maximum range of motion will be adjusted based on pain intensity comfort and patient response following a shared decision-making approach with a clinician The goal will be to maintain exercises at the greatest possible range of motion
The identification of the patient-guided angle in both open and closed kinetic chain exercises will be determined as follows the patient will perform 10 maximum repetitions on the leg with PFP prioritizing range of motion over load During the execution the range of motion and load will be guided by the numerical pain rating scale and the perceived exertion scale
Participants will complete 12 sessions twice a week supervised by a physiotherapist Assessments will be conducted at baseline six weeks and six months evaluating pain function kinesiophobia crepitus perception of effect and weekly pain-killer consumption
Open kinetic chain exercises will be performed using a leg extension machine while closed kinetic chain exercises will include free squats and Bulgarian squats
The Limited-RoM Quadriceps Strengthening group will perform open-kinetic-chain quadriceps strengthening exercises within a range of 90 to 45 of knee flexion and closed-kinetic-chain within a range of 0 to 45
The Patient-Guided-RoM Quadriceps Strengthening group will perform quadriceps strengthening exercises in both open and closed kinetic chains to the maximum tolerated by the patient based on their symptoms The patient-guided maximum range of motion will be adjusted based on pain intensity comfort and patient response following a shared decision-making approach with a clinician The goal will be to maintain exercises at the greatest possible range of motion
The identification of the patient-guided angle in both open and closed kinetic chain exercises will be determined as follows the patient will perform 10 maximum repetitions on the leg with PFP prioritizing range of motion over load During the execution the range of motion and load will be guided by the numerical pain rating scale and the perceived exertion scale
Participants will complete 12 sessions twice a week supervised by a physiotherapist Assessments will be conducted at baseline six weeks and six months evaluating pain function kinesiophobia crepitus perception of effect and weekly pain-killer consumption
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None