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

NCT ID: NCT04011436

Last Updated: 2021-11-23

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-15

Study Completion Date

2019-04-13

Brief Summary

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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

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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).

Conditions

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Patellofemoral Pain Syndrome

Keywords

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anterior knee pain patellofemoral pain syndrome AND treatment patellofemoral pain AND diagnosis patellofemoral pain syndrome AND exercise patellofemoral pain AND physiotherapy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors
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.

Study Groups

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Core, Hip and knee.

Physical Exercises to strengthen the core, hip and knee.

Group Type EXPERIMENTAL

Strengthening program

Intervention Type 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

Hip and Knee

Physical Exercises to strengthen the hip and knee.

Group Type SHAM_COMPARATOR

Strengthening program

Intervention Type 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

Interventions

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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

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

15 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Universidad Nacional de Colombia

OTHER

Sponsor Role lead

Responsible Party

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Luisa Fernanda Prieto Garcia

Physical Therapist and Master´ candidate in Physical Therapist in Sport and Physical Activity

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Juan Alzate Granados

Role: STUDY_CHAIR

Universidad Nacional de Colombia

Locations

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Universidad Nacional de Colombia

Bogotá, , Colombia

Site Status

Countries

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Colombia

References

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

Reference Type BACKGROUND
PMID: 28437495 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 8866275 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26158920 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26834185 (View on PubMed)

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

Reference Type BACKGROUND
PMID: 15995421 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25365356 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29246794 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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Patellofemoral Pain Syndrome

Identifier Type: -

Identifier Source: org_study_id