Therapeutic Effect of Two Muscle Strengthening Programs in Patients With Patellofemoral Pain Syndrome

Therapeutic Effect of Two Muscle Strengthening Programs in Patients With Patellofemoral Pain Syndrome From Bogota, Colombia. Experimental Study, Clinical Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Patellofemoral Pain Syndrome
• Intervention / Treatment: Other: Strengthening program

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).

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Colombia
  • Bogotá, Colombia, 111321
    • Universidad Nacional de Colombia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 40 years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Core, Hip and knee.; Physical Exercises to strengthen the core, hip and knee.	Other: Strengthening program; Both protocols lasted eight (8) weeks, the anatomical conditioning phase was carried out in two weeks of intervention, followed by 4 weeks of strengthening or strength increase and two additional weeks as a final or maintenance phase, at the end of which performed the final evaluations to identify if there were differences in the groups after the physiotherapeutic intervention. Group A: 28 exercises Group B: 24 exercises
Sham Comparator: Hip and Knee; Physical Exercises to strengthen the hip and knee.	Other: Strengthening program; Both protocols lasted eight (8) weeks, the anatomical conditioning phase was carried out in two weeks of intervention, followed by 4 weeks of strengthening or strength increase and two additional weeks as a final or maintenance phase, at the end of which performed the final evaluations to identify if there were differences in the groups after the physiotherapeutic intervention. Group A: 28 exercises Group B: 24 exercises

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of Change in Pain and Function Before and After Treatment With Kujala´s Test: Presented as Percentages and 95% Confidence Interval.	The Kujala patellofemoral pain scale, is an assessment tool developed to assesses pain and function in patients with disorders of the patellofemoral joint and consists of 13 questions, each with three to five response options, scored from 0 to 5, or 0 to 10, depending on the question. The lowest possible total value is 0 and corresponds to patients who are in a worse functional health condition. The highest possible total value is 100, for those that do not have any alteration and are in optimal condition. The results below, are presented as percentages and 95% confidence interval.	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".
Assessment of Change in Pain With Visual Analogue Scale	Visual Analogue Scale (VAS) is a numeric scale from 0 to 10 to measure pain (been 0 no pain and 10 worse pain).	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Patellofemoral Misalignment With Q Angle´s Exam	We measured the Q angle (degrees) between the border of the anterosuperior iliac spine, the center of the patella and the center of the tibia. the data result, shows the median values, and the interquartile range (IR) with a Delta change between measure number 1 and number 2.	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).
Change in Core Strength With McGill´s Exam	The protocol consists of 3 tests that measure all aspects of torso strength via isometric muscle endurance 1.Trunk flexor test, 2.Trunk extensor test 3. Lateral musculature test (rigth and left side). t is a timed test involving a static, isometric contraction, until the individual exhibits fatigue and can no longer hold the assumed position. The goal of the test is to hold each position for as long as possible.	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)
Change in Quadriceps and Gluteus Strength With Squat´s Test	Squat Test is a field test, easy and simple to assess the Gluteus and quadriceps muscles strength.	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)
Change in Static Balance With Single Leg Stance	This test is used to evaluate the control of postural and static balance with the eyes open and closed in seconds. (if the participant does not complete the 45 seconds framework is thought to be lacking of equilibrium).	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)
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	The amount of physical activity places patients in 1 to 3 categories: 1. Low/inactive: do not meet criteria for categories 2 or 3. 2. Moderate: meet 1 the following: a. 3 or more days with at least 20 minutes of vigorous activity b. 5 or more days with at least 30 minutes of moderate-intensity activity or walking. c. 5 or more days with any combination of walking, moderate-intensity, or vigorous intensity activities with at least 600 MET-min/week. 3. High: meet 1 of the following: a. 3 or more days of vigorous-intensity activity and at least 1500 MET-min/week. b. 7 days of any combination of walking moderate-intensity, or vigorous intensity activities with at least 3000 MET-min/week. We decided to add the time in minutes for each category of the IPAQ (work, transport, home and recreation), to obtain a more objective calculation, and to be able to make comparisons between the two different time points.	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)

Collaborators and Investigators

• Sponsor: Universidad Nacional de Colombia
• Investigators: Study Chair: Juan Alzate Granados, Universidad Nacional de Colombia

Publications and helpful links

General Publications

• 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.
• Van Der Heijden RA, Lankhorst NE, Van Linschoten R, Bierma-Zeinstra SM, Van Middelkoop M. Exercise for treating patellofemoral pain syndrome: an abridged version of Cochrane systematic review. Eur J Phys Rehabil Med. 2016 Feb;52(1):110-33. Epub 2015 Jul 9.
• Fulkerson JP. A Practical Guide to Understanding and Treating Patellofemoral Pain. Am J Orthop (Belle Mead NJ). 2017 Mar/Apr;46(2):101-103.
• Witvrouw E, Sneyers C, Lysens R, Victor J, Bellemans J. Reflex response times of vastus medialis oblique and vastus lateralis in normal subjects and in subjects with patellofemoral pain syndrome. J Orthop Sports Phys Ther. 1996 Sep;24(3):160-5. doi: 10.2519/jospt.1996.24.3.160.
• Selfe J, Janssen J, Callaghan M, Witvrouw E, Sutton C, Richards J, Stokes M, Martin D, Dixon J, Hogarth R, Baltzopoulos V, Ritchie E, Arden N, Dey P. Are there three main subgroups within the patellofemoral pain population? A detailed characterisation study of 127 patients to help develop targeted intervention (TIPPs). Br J Sports Med. 2016 Jul;50(14):873-80. doi: 10.1136/bjsports-2015-094792. Epub 2016 Feb 1.
• Grelsamer RP. Patellar nomenclature: the Tower of Babel revisited. Clin Orthop Relat Res. 2005 Jul;(436):60-5.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 15, 2018
• Primary Completion (Actual): January 13, 2019
• Study Completion (Actual): April 13, 2019

Study Registration Dates

• First Submitted: June 21, 2019
• First Submitted That Met QC Criteria: July 5, 2019
• First Posted (Actual): July 8, 2019

Study Record Updates

• Last Update Posted (Actual): November 23, 2021
• Last Update Submitted That Met QC Criteria: October 22, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: anterior knee pain; patellofemoral pain syndrome AND treatment; patellofemoral pain AND diagnosis; patellofemoral pain syndrome AND exercise; patellofemoral pain AND physiotherapy
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Disease; Joint Diseases; Musculoskeletal Diseases; Syndrome; Somatoform Disorders; Patellofemoral Pain Syndrome
• Other Study ID Numbers: patellofemoral pain syndrome

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The investigators are not yet sure of sharing the IPD (individual participant data) of this study because they want to publish an article first and then decide.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No