Clinical trial NCT06502795: Quadriceps Strengthening At Different Angles in Patellofemoral Pain
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Patellofemoral Pain Syndrome
Keywords: Patellofemoral Joint
Chondromalacia Patellae
Physical Therapy Modalities
Quadriceps Muscle
Resistance Training
Exercise Therapy
Lead sponsor: Universidade Federal do Ceara
Sponsor class: OTHER
First posted: 2024-07-16
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a randomized clinical trial with two parallel groups, balanced 1:1 allocation, and double-blind design.
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Knee pain intensity
timeFrame: Knee pain intensity measured by the NPRS after six-week intervention.
measure: Kinesiophobia
timeFrame: Kinesiophobia assessed by the Tampa Scale of Kinesiophobia after six-week intervention.
Secondary outcomes:
measure: Perception of effect
timeFrame: Global Rating of Change Scale after six-week intervention and six-month follow-up.
measure: Knee crepitus
timeFrame: Crepitus during knee extension after six-week intervention.
measure: Weekly analgesic consumption
timeFrame: Weekly, throughout the six-week intervention period.
measure: Knee pain intensity
timeFrame: Knee pain intensity measured by the NPRS at six-month follow-up.
measure: Knee function
timeFrame: Self-reported function measured by the AKPS at six-week and six-month follow-up.
measure: Kinesiophobia
timeFrame: Kinesiophobia assessed by the Tampa Scale of Kinesiophobia six-month follow-up.
measure: Quadriceps peak torque
timeFrame: Quadriceps strength measured by the isokinetic dynamometer after six-week intervention.
Other outcomes:
Locations:
city: Fortaleza
country: Brazil
facility: Physiotherapy Department, Federal University of Ceará
state: Ceará
Study officials:
References:
citation: 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.
citation: Collins 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.
citation: Collins 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.
citation: Crossley 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.
citation: da 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.
citation: Escamilla 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.
citation: Gallasch CH, Alexandre NM. The measurement of musculoskeletal pain intensity: a comparison of four methods. Rev Gaucha Enferm. 2007 Jun;28(2):260-5.
citation: Giles 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.
citation: Hansen 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.
citation: Kamper 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.
citation: Lack 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.
citation: Maclachlan 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.
citation: de 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.
citation: de 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.
citation: Powers 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.
citation: Powers CM, Witvrouw E, Davis IS, Crossley KM. Evidence-based framework for a pathomechanical model of patellofemoral pain: 2017 patellofemoral pain consensus statement from the 4th International Patellofemoral Pain Research Retreat, Manchester, UK: part 3. Br J Sports Med. 2017 Dec;51(24):1713-1723. doi: 10.1136/bjsports-2017-098717. Epub 2017 Nov 6. No abstract available.
citation: Priore LB, Azevedo FM, Pazzinatto MF, Ferreira AS, Hart HF, Barton C, de Oliveira Silva D. Influence of kinesiophobia and pain catastrophism on objective function in women with patellofemoral pain. Phys Ther Sport. 2019 Jan;35:116-121. doi: 10.1016/j.ptsp.2018.11.013. Epub 2018 Nov 28.
citation: Smith BE, Selfe J, Thacker D, Hendrick P, Bateman M, Moffatt F, Rathleff MS, Smith TO, Logan P. Incidence and prevalence of patellofemoral pain: A systematic review and meta-analysis. PLoS One. 2018 Jan 11;13(1):e0190892. doi: 10.1371/journal.pone.0190892. eCollection 2018.
citation: Stathopulu E, Baildam E. Anterior knee pain: a long-term follow-up. Rheumatology (Oxford). 2003 Feb;42(2):380-2. doi: 10.1093/rheumatology/keg093.
citation: Steinkamp LA, Dillingham MF, Markel MD, Hill JA, Kaufman KR. Biomechanical considerations in patellofemoral joint rehabilitation. Am J Sports Med. 1993 May-Jun;21(3):438-44. doi: 10.1177/036354659302100319.
citation: Willy RW, Hoglund LT, Barton CJ, Bolgla LA, Scalzitti DA, Logerstedt DS, Lynch AD, Snyder-Mackler L, McDonough CM. Patellofemoral Pain. J Orthop Sports Phys Ther. 2019 Sep;49(9):CPG1-CPG95. doi: 10.2519/jospt.2019.0302.