Patellofemoral Pain SyndromeNCT06502795
Quadriceps Strengthening At Different Angles in Patellofemoral Pain
A study testing Protected Range Quadriceps Strengthening group and Patient-Guided Range Quadriceps Strengthening group in people with Patellofemoral Pain Syndrome, run by Universidade Federal do Ceara at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 years
- Conditions the study is for
- Patellofemoral Pain Syndrome
- What is being tested?
- Protected Range Quadriceps Strengthening group and Patient-Guided Range Quadriceps Strengthening group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteBrazil
- Study dates
- 26 Oct 2024to Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 9Show fewer
- Presence of knee joint edema.
- Contraindications to resistance exercises informed by a physician.
- Corticosteroid injection within the last 6 months.
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Physiotherapy Department, Federal University of Ceará
Fortaleza, Ceará, 60430-450
Gabriel PL Almeida, PhD, +55 (85) 3366 8091, gabriel_alm@ufc.br
About this study
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
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.
Read the 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.
- Conditions
- Patellofemoral Pain Syndrome
- Being tested
- Protected Range Quadriceps Strengthening group, Patient-Guided Range Quadriceps Strengthening group
- Keywords
- Patellofemoral Joint, Chondromalacia Patellae, Physical Therapy Modalities, Quadriceps Muscle, Resistance Training, Exercise Therapy
- Medical subject headings
- Patellofemoral Pain Syndrome, Chondromalacia Patellae
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Protected Range Quadriceps Strengthening groupOther
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.
Patient-Guided Range Quadriceps Strengthening groupOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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°. Receives: 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. Receives: Other: Patient-Guided Range Quadriceps Strengthening group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Kinesiophobia assessed by the Tampa Scale of Kinesiophobia after six-week intervention.
Secondary outcomes (7)
Perception of effect
Global Rating of Change Scale- This scale consists of 11 points ranging from minus five (extremely worse), zero (no change) to five (completely recovered). For all measures of perceived global effect, participants were asked: "Compared to the beginning of this episode, how would you describe your knee today?" Positive scores indicate better recovery, while negative scores indicate worsening of symptoms.
Measured: Global Rating of Change Scale after six-week intervention and six-month follow-up.
Knee crepitus
The investigator places the palm of their hand over each participant's patella to detect the presence of a grinding sensation during knee extension performed on the leg extension machine. Participants will be instructed to perform two knee extensions as far as they can during the assessment. The test will be considered positive for knee crepitus when a grinding or popping sensation is detected during the range of motion. However, one or two occasional pops will not be considered crepitus. This test has been previously conducted in individuals with PFP.
Measured: Crepitus during knee extension after six-week intervention.
Weekly analgesic consumption
The patient will be asked if they have taken pain medications in the last week. If the answer is yes, it will be identified which medications (opioids, anti-inflammatories, or analgesics) were taken and how many medications were consumed.
Measured: Weekly, throughout the six-week intervention period.
Knee pain intensity
Pain intensity will be measured using the NPRS, which ranges from 0 to 10 points, where 0 represents no pain and 10 represents the worst possible pain.
Measured: Knee pain intensity measured by the NPRS at six-month follow-up.
Knee function
Anterior Knee Pain Scale - AKPS: Specific questionnaire for anterior knee pain comprising 13 items with separate categories related to different levels of knee function.
Measured: Self-reported function measured by the AKPS at six-week and six-month follow-up.
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.
Measured: Kinesiophobia assessed by the Tampa Scale of Kinesiophobia six-month follow-up.
Quadriceps peak torque
Peak torque (Nm) and limb symmetry index on the isokinetic dynamometer, angular velocity of 60 degrees per second, and CON/CON mode.
Measured: Quadriceps strength measured by the isokinetic dynamometer after six-week intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2024
- Study start26 Oct 2024
- Primary completionDec 2024 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (21)Papers the sponsor has linked to this study.
- Other trials for Patellofemoral Pain SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a randomized clinical trial with two parallel groups, balanced 1:1 allocation, and double-blind design.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade Federal do Ceara
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gabriel Peixoto Leão Almeida, Universidade Federal do Ceara
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06502795
- Sponsor's protocol ID
- PFPKarine
- Status last verified
- Oct 2024
- First submitted
- 9 Jul 2024
- Last updated
- 30 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Variable characterization will employ descriptive statistical tests (frequency, mean, and standard deviation). Group differences and corresponding confidence intervals will be calculated using mixed linear models incorporating an interaction term for "time versus group." These interaction terms represent group differences (intervention effect). Covariates known to influence clinical outcomes in our study, such as bilateral/unilateral pain presence, symptom duration, and sex, will be incorporated into the statistical models. Statistical analyses will be conducted using SPSS 20.0 for Windows (Statistical Package for the Social Sciences Inc., Chicago, IL, USA) with a significance level set at 5% (α \< 0.05).
Publications
Almeida GPL, Rodrigues HLDN, Coelho BAL, Rodrigues CAS, Lima POP. Anteromedial versus posterolateral hip musculature strengthening with dose-controlled in women with patellofemoral pain: A randomized controlled trial. Phys Ther Sport. 2021 May;49:149-156. doi: 10.1016/j.ptsp.2021.02.016. Epub 2021 Mar 2.
PubMed 33689989Collins NJ, Bierma-Zeinstra SM, Crossley KM, van Linschoten RL, Vicenzino B, van Middelkoop M. Prognostic factors for patellofemoral pain: a multicentre observational analysis. Br J Sports Med. 2013 Mar;47(4):227-33. doi: 10.1136/bjsports-2012-091696. Epub 2012 Dec 13.
PubMed 23242955Collins NJ, Barton CJ, van Middelkoop M, Callaghan MJ, Rathleff MS, Vicenzino BT, Davis IS, Powers CM, Macri EM, Hart HF, de Oliveira Silva D, Crossley KM. 2018 Consensus statement on exercise therapy and physical interventions (orthoses, taping and manual therapy) to treat patellofemoral pain: recommendations from the 5th International Patellofemoral Pain Research Retreat, Gold Coast, Australia, 2017. Br J Sports Med. 2018 Sep;52(18):1170-1178. doi: 10.1136/bjsports-2018-099397. Epub 2018 Jun 20.
PubMed 29925502Crossley KM, Bennell KL, Cowan SM, Green S. Analysis of outcome measures for persons with patellofemoral pain: which are reliable and valid? Arch Phys Med Rehabil. 2004 May;85(5):815-22. doi: 10.1016/s0003-9993(03)00613-0.
PubMed 15129407da Cunha RA, Costa LO, Hespanhol Junior LC, Pires RS, Kujala UM, Lopes AD. Translation, cross-cultural adaptation, and clinimetric testing of instruments used to assess patients with patellofemoral pain syndrome in the Brazilian population. J Orthop Sports Phys Ther. 2013 May;43(5):332-9. doi: 10.2519/jospt.2013.4228. Epub 2013 Mar 13.
PubMed 23485881Escamilla RF, Fleisig GS, Zheng N, Barrentine SW, Wilk KE, Andrews JR. Biomechanics of the knee during closed kinetic chain and open kinetic chain exercises. Med Sci Sports Exerc. 1998 Apr;30(4):556-69. doi: 10.1097/00005768-199804000-00014.
PubMed 9565938Gallasch CH, Alexandre NM. The measurement of musculoskeletal pain intensity: a comparison of four methods. Rev Gaucha Enferm. 2007 Jun;28(2):260-5.
PubMed 17907648Giles L, Webster KE, McClelland J, Cook JL. Quadriceps strengthening with and without blood flow restriction in the treatment of patellofemoral pain: a double-blind randomised trial. Br J Sports Med. 2017 Dec;51(23):1688-1694. doi: 10.1136/bjsports-2016-096329. Epub 2017 May 12.
PubMed 28500081Hansen R, Brushoj C, Rathleff MS, Magnusson SP, Henriksen M. Quadriceps or hip exercises for patellofemoral pain? A randomised controlled equivalence trial. Br J Sports Med. 2023 Oct;57(20):1287-1294. doi: 10.1136/bjsports-2022-106197. Epub 2023 May 3.
PubMed 37137673Kamper SJ, Maher CG, Mackay G. Global rating of change scales: a review of strengths and weaknesses and considerations for design. J Man Manip Ther. 2009;17(3):163-70. doi: 10.1179/jmt.2009.17.3.163.
PubMed 20046623Lack S, Barton C, Sohan O, Crossley K, Morrissey D. Proximal muscle rehabilitation is effective for patellofemoral pain: a systematic review with meta-analysis. Br J Sports Med. 2015 Nov;49(21):1365-76. doi: 10.1136/bjsports-2015-094723. Epub 2015 Jul 14.
PubMed 26175019Maclachlan LR, Collins NJ, Matthews MLG, Hodges PW, Vicenzino B. The psychological features of patellofemoral pain: a systematic review. Br J Sports Med. 2017 May;51(9):732-742. doi: 10.1136/bjsports-2016-096705. Epub 2017 Mar 20.
PubMed 28320733de Oliveira Silva D, Barton C, Crossley K, Waiteman M, Taborda B, Ferreira AS, Azevedo FM. Implications of knee crepitus to the overall clinical presentation of women with and without patellofemoral pain. Phys Ther Sport. 2018 Sep;33:89-95. doi: 10.1016/j.ptsp.2018.07.007. Epub 2018 Jul 17.
PubMed 30059950de Oliveira Silva D, Barton CJ, Briani RV, Taborda B, Ferreira AS, Pazzinatto MF, Azevedo FM. Kinesiophobia, but not strength is associated with altered movement in women with patellofemoral pain. Gait Posture. 2019 Feb;68:1-5. doi: 10.1016/j.gaitpost.2018.10.033. Epub 2018 Nov 1.
PubMed 30408709Powers CM, Ho KY, Chen YJ, Souza RB, Farrokhi S. Patellofemoral joint stress during weight-bearing and non-weight-bearing quadriceps exercises. J Orthop Sports Phys Ther. 2014 May;44(5):320-7. doi: 10.2519/jospt.2014.4936. Epub 2014 Mar 27.
PubMed 24673446
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06502795
- Acronym / sponsor ID
- PFPKarine
- Conditions
- Patellofemoral Pain Syndrome
- Keywords
- Patellofemoral Joint, Chondromalacia Patellae, Physical Therapy Modalities, Quadriceps Muscle, Resistance Training, Exercise Therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Universidade Federal do CearaUniversity, hospital or other
- Study start
- 26 Oct 2024 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 16 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- This is a randomized clinical trial with two parallel groups, balanced 1:1 allocation, and double-blind design.
| Arm | Type | Receives |
|---|---|---|
| Limited Range of Motion Quadriceps Strengthening group | Experimental | Other: Protected Range Quadriceps Strengthening groupThe 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°. |
| Patient-Guided Range of Motion Quadriceps Strengthening group | Active comparator | Other: Patient-Guided Range Quadriceps Strengthening groupThe 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. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Protected Range Quadriceps Strengthening groupWarm-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. | Other | Limited Range of Motion Quadriceps Strengthening group |
| Patient-Guided Range Quadriceps Strengthening groupWarm-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. | Other | Patient-Guided Range of Motion Quadriceps Strengthening group |
Primary outcome
Knee pain intensity
Time frame: Knee pain intensity measured by the NPRS after six-week intervention.
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.
Kinesiophobia
Time frame: Kinesiophobia assessed by the Tampa Scale of Kinesiophobia after six-week intervention.
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.
7 secondary outcomes
Perception of effect
Time frame: Global Rating of Change Scale after six-week intervention and six-month follow-up.
Knee crepitus
Time frame: Crepitus during knee extension after six-week intervention.
Weekly analgesic consumption
Time frame: Weekly, throughout the six-week intervention period.
Knee pain intensity
Time frame: Knee pain intensity measured by the NPRS at six-month follow-up.
Knee function
Time frame: Self-reported function measured by the AKPS at six-week and six-month follow-up.
Kinesiophobia
Time frame: Kinesiophobia assessed by the Tampa Scale of Kinesiophobia six-month follow-up.
Quadriceps peak torque
Time frame: Quadriceps strength measured by the isokinetic dynamometer after six-week intervention.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2024.
- Background: PubMed 33689989Almeida GPL, Rodrigues HLDN, Coelho BAL, Rodrigues CAS, Lima POP. Anteromedial versus posterolateral hip musculature strengthening with dose-controlled in women with patellofemoral pain: A randomized controlled trial. Phys Ther Sport. 2021 May;49:149-156. doi: 10.1016/j.ptsp.2021.02.016. Epub 2021 Mar 2.
- Background: PubMed 23242955Collins NJ, Bierma-Zeinstra SM, Crossley KM, van Linschoten RL, Vicenzino B, van Middelkoop M. Prognostic factors for patellofemoral pain: a multicentre observational analysis. Br J Sports Med. 2013 Mar;47(4):227-33. doi: 10.1136/bjsports-2012-091696. Epub 2012 Dec 13.
- Background: PubMed 29925502Collins NJ, Barton CJ, van Middelkoop M, Callaghan MJ, Rathleff MS, Vicenzino BT, Davis IS, Powers CM, Macri EM, Hart HF, de Oliveira Silva D, Crossley KM. 2018 Consensus statement on exercise therapy and physical interventions (orthoses, taping and manual therapy) to treat patellofemoral pain: recommendations from the 5th International Patellofemoral Pain Research Retreat, Gold Coast, Australia, 2017. Br J Sports Med. 2018 Sep;52(18):1170-1178. doi: 10.1136/bjsports-2018-099397. Epub 2018 Jun 20.
- Background: PubMed 15129407Crossley KM, Bennell KL, Cowan SM, Green S. Analysis of outcome measures for persons with patellofemoral pain: which are reliable and valid? Arch Phys Med Rehabil. 2004 May;85(5):815-22. doi: 10.1016/s0003-9993(03)00613-0.
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- Individual participant dataSharing planned: Yes. Variable characterization will employ descriptive statistical tests (frequency, mean, and standard deviation). Group differences and corresponding confidence intervals will be calculated using mixed linear models incorporating an interaction term for "time versus group." These interaction terms represent group differences (intervention effect). Covariates known to influence clinical outcomes in our study, such as bilateral/unilateral pain presence, symptom duration, and sex, will be incorporated into the statistical models. Statistical analyses will be conducted using SPSS 20.0 for Windows (Statistical Package for the Social Sciences Inc., Chicago, IL, USA) with a significance level set at 5% (α < 0.05).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Protected Range Quadriceps Strengthening group and Patient-Guided Range Quadriceps Strengthening group in people with Patellofemoral Pain Syndrome, run by Universidade Federal do Ceara at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gabriel Almeida, DSc (+55(85)999590400, gabriel_alm@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Knee pain intensity (time frame: Knee pain intensity measured by the NPRS after six-week intervention.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06502795, which also lists 21 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2024.