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

Patellofemoral Pain Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04011436
• Other study ID #: Patellofemoral Pain Syndrome
• Status: Completed
• Phase: N/A
• Start date: August 15, 2018
• Est. completion date: April 13, 2019

Study information

• Verified date: October 2021
• Source: Universidad Nacional de Colombia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: April 13, 2019
• Est. primary completion date: January 13, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 15 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Patellofemoral Pain Syndrome
• Somatoform Disorders
• Syndrome

Intervention

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

Locations

Country	Name	City	State
Colombia	Universidad Nacional de Colombia	Bogotá

Sponsors (1)

Lead Sponsor	Collaborator
Universidad Nacional de Colombia

Country where clinical trial is conducted

Colombia, 

References & Publications (7)

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. Review. — View 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. Review. — View Citation

Fulkerson JP. A Practical Guide to Understanding and Treating Patellofemoral Pain. Am J Orthop (Belle Mead NJ). 2017 Mar/Apr;46(2):101-103. Review. — View Citation

Grelsamer RP. Patellar nomenclature: the Tower of Babel revisited. Clin Orthop Relat Res. 2005 Jul;(436):60-5. Review. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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".
Primary	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	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).
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)