Quadriceps Strengthening At Different Angles in Patellofemoral Pain

NCT06502795 | Recruiting

• 1 other identifier: PFPKarine
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

Introduction: Patellofemoral pain (PFP) is characterized by anterior, retropatellar and/or 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 1:1 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.

Conditions

Patellofemoral Pain Syndrome

Keywords

Patellofemoral Joint; Chondromalacia Patellae; Physical Therapy Modalities; Quadriceps Muscle; Resistance Training; Exercise Therapy

Outcome Measures

Primary Outcomes (2)

• Knee pain intensity

  Pain intensity will be measured using the numeric pain rating scale (NPRS), which ranges from 0 to 10 points, where 0 represents no pain and 10 represents the worst possible pain.

  Knee pain intensity measured by the NPRS after six-week intervention.

• Kinesiophobia

  The Tampa Scale is a 17-item questionnaire designed to quantify fear of movement and re-injury due to movement and physical activity on a scale from 17 to 68, where 68 indicates higher fear of re-injury due to movement.

  Kinesiophobia assessed by the Tampa Scale of Kinesiophobia after six-week intervention.

Secondary Outcomes (7)

• Perception of effect

  Global Rating of Change Scale after six-week intervention and six-month follow-up.

• Knee crepitus

  Crepitus during knee extension after six-week intervention.

• Weekly analgesic consumption

  Weekly, throughout the six-week intervention period.

• Knee pain intensity

  Knee pain intensity measured by the NPRS at six-month follow-up.

• Knee function

  Self-reported function measured by the AKPS at six-week and six-month follow-up.

Study Arms (2)

Limited Range of Motion Quadriceps Strengthening group

EXPERIMENTAL

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°.

Other: Protected Range Quadriceps Strengthening group

Patient-Guided Range of Motion Quadriceps Strengthening group

ACTIVE COMPARATOR

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.

Other: Patient-Guided Range Quadriceps Strengthening group

Interventions

Protected Range Quadriceps Strengthening group OTHER

Warm-up: Start with 5 minutes of stationary biking. Then, proceed with two sets of 30-second dynamic stretches targeting the quadriceps, hamstrings, calf muscles, and adductors, followed by static stretching for the abductors. Strengthening: Complete 3 sets of 8-12 repetitions for each exercise, aiming for a perceived effort level on the Borg scale between 60% and 80%. Increase the load by 2%-10% when the patient can perform 14 or more repetitions in the final set while maintaining the Borg scale between 60% and 80%. For the Leg Extension Machine, maintain a range of motion between 90 to 45 degrees. During Squats and Bulgarian Squats, aim for a range of motion between 0 to 45 degrees.

Limited Range of Motion Quadriceps Strengthening group

Patient-Guided Range Quadriceps Strengthening group OTHER

Warm-up: 5 minutes of stationary biking. Next, perform two sets of 30-second stretches for the quadriceps, hamstrings, calf muscles, adductors and abductors hip. Strengthening: Patients will complete 3 sets of 8 to 12 repetitions for each exercise, aiming for a perceived effort level of 60% to 80% on the Borg scale. Load will be increased by 2% to 10% when patients can complete 14 or more repetitions in the final set while maintaining the Borg scale between 60% and 80%. Quadriceps strengthening will be performed at the patient's maximum range guided by symptoms, with pain intensity capped at 5 points on the NPRS. The patient-guided range will be adjusted based on pain intensity, comfort, and patient response, using a shared decision-making approach. The goal is to maintain exercises at the maximum possible range of motion. For the Leg Extension Machine, Squats, and Bulgarian Squats, the range of motion will be guided by the patient's pain tolerance.

Patient-Guided Range of Motion Quadriceps Strengthening group

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Individuals aged between 18 and 35 years.
• Diagnosis of patellofemoral pain characterized by peri- or retropatellar pain.
• Pain reproduced in at least two of the following activities: ascending or descending stairs, squatting, kneeling, prolonged sitting, jumping, running, or palpation of the medial and/or lateral facets of the patella.
• Insidious onset of symptoms.
• Symptoms duration of at least three months.
• Minimum score of three on the numerical pain rating scale (NPRS) in the past week.
• Maximum score of 86 points on the Anterior Knee Pain Scale (AKPS)
• In cases of bilateral pain, the more symptomatic knee will be included.

You may not qualify if:

• History of surgery and/or fractures in the lower limb joints.
• Other knee joint-related injuries such as meniscal tears, ligament injuries.
• History of patellar subluxation or dislocation.
• Signs of osteoarthritis.
• Patellar and quadriceps tendinopathy.
• Osgood-Schlatter syndrome.
• Presence of knee joint edema.
• Contraindications to resistance exercises informed by a physician.
• Corticosteroid injection within the last 6 months.

Sponsors & Collaborators

• Universidade Federal do Ceara: lead

Study Sites (1)

Physiotherapy Department, Federal University of Ceará

Fortaleza, Ceará, 60430-450, Brazil

RECRUITING

Related Publications (21)

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MeSH Terms

Conditions

Patellofemoral Pain Syndrome; Chondromalacia Patellae

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Cartilage Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Gabriel Almeida, DSc

CONTACT

+55(85)999590400; gabriel_alm@hotmail.com

Ana Karine S Nunes, PT

CONTACT

+55(85)988302157; karinesn5@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: The randomization process will be conducted by a researcher not involved in data collection, using computer-generated random numbers from the Random Allocation Software (version 2.0), in a 1:1 ratio. Randomization codes will be placed in opaque, sequentially numbered envelopes, sealed with a tamper-proof seal, and will be opened only after the envelope has been irreversibly assigned to the participant. The evaluator and the patient will be blinded to the allocation in the experimental and control groups. At the end of the intervention, a masking test will be conducted.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: This is a randomized clinical trial with two parallel groups, balanced 1:1 allocation, and double-blind design.

Study Record Dates

• First Submitted: July 9, 2024
• First Posted: July 16, 2024
• Study Start: October 26, 2024
• Primary Completion: December 1, 2024
• Study Completion (Estimated): June 1, 2026
• Last Updated: October 30, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP

Locations

BR (1)