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

NCT04011436 | Completed Results

• 1 other identifier: Patellofemoral Pain Syndrome
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• Change in Patellofemoral Misalignment With Q Angle´s Exam

  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 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

  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

  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

  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)

Study Arms (2)

Core, Hip and knee.

EXPERIMENTAL

Physical Exercises to strengthen the core, hip and knee.

Other: Strengthening program

Hip and Knee

SHAM COMPARATOR

Physical Exercises to strengthen the hip and knee.

Other: Strengthening program

Interventions

Strengthening program OTHER

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

Core, Hip and knee.; Hip and Knee

Eligibility Criteria

• Age: 15 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad Nacional de Colombia: lead

Study Sites (1)

Universidad Nacional de Colombia

Bogotá, 111321, Colombia

Location

Related Publications (7)

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

  PMID: 28437495 BACKGROUND

• 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.

  PMID: 8866275 BACKGROUND

• 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.

  PMID: 26158920 BACKGROUND

• 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.

  PMID: 26834185 BACKGROUND

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

  PMID: 15995421 BACKGROUND

• 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.

  PMID: 25365356 BACKGROUND

• 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.

  PMID: 29246794 BACKGROUND

MeSH Terms

Conditions

Patellofemoral Pain Syndrome

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Results Point of Contact

• Title: Pt. Luisa Prieto
• Organization: Universidad Nacional de Colombia

lfprietog@unal.edu.co

+57 3202082723

Study Officials

• Juan Alzate Granados

  Universidad Nacional de Colombia

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: SNOSE: Sequentially Numbered, Opaque Sealed Envelopes. The forty subjects of the experimental procedure were assigned to the two intervention groups from three steps: 1. A paper / charcoal sheet was placed on an Assignation paper marked with Group A or Group B, 2. Then they were lined with aluminum foil, also rectangular and 3. They were finally inserted in a white envelope which was sealed with glue. Forty of these envelopes were made, twenty for Group A and the other half for Group B, after that, they were mixed in a cardboard box and then enumerated one by one at random until the 40 envelopes were completed. Each envelope was delivered in order of numbering to each of the patients who were entering the treatment. The investigator directed the strengthening program and another Physical Therapist addressed the tests.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physical Therapist and Master´ candidate in Physical Therapist in Sport and Physical Activity

Model Details: 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).

Study Record Dates

• First Submitted: June 21, 2019
• First Posted: July 8, 2019
• Study Start: August 15, 2018
• Primary Completion: January 13, 2019
• Study Completion: April 13, 2019
• Last Updated: November 23, 2021
• Results First Posted: November 23, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

CO (1)