Clinical trial NCT04011436: Therapeutic Effect of Two Muscle Strengthening Programs in Patients With Patellofemoral Pain Syndrome
Official title: Therapeutic Effect of Two Muscle Strengthening Programs in Patients With Patellofemoral Pain Syndrome From Bogota, Colombia. Experimental Study, Clinical Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Patellofemoral Pain Syndrome
Keywords: anterior knee pain
patellofemoral pain syndrome AND treatment
patellofemoral pain AND diagnosis
patellofemoral pain syndrome AND exercise
patellofemoral pain AND physiotherapy
Lead sponsor: Universidad Nacional de Colombia
Sponsor class: OTHER
First posted: 2019-07-08
Enrollment: 40
Sex: ALL
Minimum age (years): 15
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Experimental study type controlled clinical trial, designed to evaluate the effect of two muscle strengthening programs in people with patellofemoral pain syndrome (Group A: Exercises for core, hip and knee and Group B: exercises for hip and knee).
Primary purpose: TREATMENT

Brief summary: Introduction: The patellofemoral pain syndrome (SPF) is one of the most frequent pathologies generated by the knee joint. Conservative treatment with physiotherapy exercises reduces pain and improves functional capacity in the short and medium term. The purpose of this study was to evaluate the therapeutic effect of combining a program of muscle strengthening exercises for the core, hip and knee on anterior knee pain in non-athletic patients with SPF. Materials and methods: Randomized controlled trial clinical trial, designed to evaluate the effect of two muscle strengthening programs in people with SPF (Group A: exercises for core, hip and knee, Group B: exercises for hip and knee), during eight weeks of intervention in people between 15 and 40 years of age, with a clinical diagnosis of SPF, with a level of mild to moderate physical activity. The Kujala test was used to measure pain and quality of life.

Detailed description: Experimental study: controlled clinical trial, designed to evaluate the effect of two muscle strengthening programs in people with patellofemoral pain syndrome.

Young adults between 15 and 40 years old, with clinical diagnosis of patellofemoral pain syndrome (by means of Computerized Axial Tomography and medical concept of a specialist Orthopedist in knee), in the last three years, non-athletes with a level of physical activity between mild and moderate, affiliated to the health care institution CAFAM (Caja de Compensación Familiar is a compensation fund of Colombia that has pharmacies, hotels, Convention Center, Recreation Club, School, among others and offers Subsidy Services, Credits, Insurance, Tourism, Health, Education, Housing).

All the procedures developed within the study had as a reference the standards of good clinical practice and ethical principles for medical research in humans. The participants signed the informed consent where they accepted their participation in the present study.

The participants were randomized with the SNOSE (sequentially numbered, opaque sealed envelopes) method to two protocols of muscular strengthening (Group A: Exercises for core, hip and knee and Group B: Exercises for Hip and Knee).

Eligibility criteria: Inclusion Criteria:

* Patients with a clinical diagnosis of patellofemoral misalignment with knee CT, aged between 15 and 40 years.
* Patients with clinical signs of retropatellar pain at rest or in the following activities: going up or down stairs, jumping, running, doing squats, kneeling, or sitting for a long time.
* Pain or apprehension to the mobilization of the patella.
* Crepitus with pain when performing squats.
* Confirmatory CT of unilateral or bilateral patellofemoral misalignment.

Exclusion Criteria:

* Clinical history or clinical evidence of patellofemoral dislocation, subluxation or osteoarthrosis of the knees.
* Dysfunction of the ligaments, bursa, meniscus, patellar tendon or synovial plica of the knee.
* Traumatic lesions of ligaments or meniscus or patients with osteoarthrosis secondary to congenital conditions.
* Clinical history of orthopedic surgery in lower limbs.

Primary outcomes:
measure: Assessment of Change in Pain and Function Before and After Treatment With Kujala´s Test: Presented as Percentages and 95% Confidence Interval.
timeFrame: The next table shows the distribution of the 13 domains of the Kujala´Test by intervention group at baseline (Time point 1, one day before intervention). "Assessed at baseline and after treatment, only baseline pre-specified to be reported".
measure: Assessment of Change in Pain With Visual Analogue Scale
timeFrame: The pain assessment will be done at two different time points (Time point 1 is baseline, one day before intervention and Time point 2 is 8 weeks post-intervention)
Secondary outcomes:
measure: Change in Patellofemoral Misalignment With Q Angle´s Exam
timeFrame: The Q angle assessment will be done at two different time points (Time point 1 is baseline, one day before intervention and Time point 2 is 8 weeks post-intervention).
measure: Change in Core Strength With McGill´s Exam
timeFrame: The Core strength assessment will be done at two different time points (Time point 1 is baseline, one day before intervention and Time point 2 is 8 weeks post-intervention)
measure: Change in Quadriceps and Gluteus Strength With Squat´s Test
timeFrame: Quadriceps and gluteus Strength assessment will be done at two different time points (Time point 1 is baseline, one day before intervention and Time point 2 is 8 weeks post-intervention)
measure: Change in Static Balance With Single Leg Stance
timeFrame: Static Balance assesment will be done at two different time points (Time point 1 is baseline, one day before intervention and Time point 2 is 8 weeks post-intervention)
measure: Change in the Total Amount (Work, Transport, Home and Recreation) of Physical Activity Reported in Minutes and Measured With The International Physical Activity Questionnaire-Long Form
timeFrame: Physical Activity will be measured at two different time points (Time point 1 is baseline, one day before intervention and Time point 2 is 8 weeks post-intervention)
Other outcomes:
Locations:
city: Bogotá
country: Colombia
facility: Universidad Nacional de Colombia
Study officials:
affiliation: Universidad Nacional de Colombia
name: Juan Alzate Granados
role: STUDY_CHAIR
References:
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citation: Bloomer BA, Durall CJ. Does the Addition of Hip Strengthening to a Knee-Focused Exercise Program Improve Outcomes in Patients With Patellofemoral Pain Syndrome? J Sport Rehabil. 2015 Nov;24(4):428-33. doi: 10.1123/jsr.2014-0184. Epub 2014 Oct 29.
citation: De Blaiser C, Roosen P, Willems T, Danneels L, Bossche LV, De Ridder R. Is core stability a risk factor for lower extremity injuries in an athletic population? A systematic review. Phys Ther Sport. 2018 Mar;30:48-56. doi: 10.1016/j.ptsp.2017.08.076. Epub 2017 Aug 24.