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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04011436
Recruitment Status : Completed
First Posted : July 8, 2019
Last Update Posted : July 8, 2019
Sponsor:
Information provided by (Responsible Party):
Luisa Fernanda Prieto Garcia, Universidad Nacional de Colombia

Tracking Information
First Submitted Date  ICMJE June 21, 2019
First Posted Date  ICMJE July 8, 2019
Last Update Posted Date July 8, 2019
Actual Study Start Date  ICMJE August 15, 2018
Actual Primary Completion Date January 13, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 5, 2019)
  • Assessment of change in pain and function before and after treatment with kujala´s Test [ Time Frame: The pain assessment and the functionality 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). ]
    Kujala is a numeric scale from 0 to 100 to evaluate pain and function with 13 question (been 0 worse pain and dysfunction and 100 no pain and good function)
  • Assessment of change in pain with Visual Analogue Scale [ Time Frame: 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) ]
    Visual Analogue Scale (VAS) is a numeric scale from 0 to 10 to measure pain (been 0 no pain and 10 worse pain).
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: July 5, 2019)
  • Patellofemoral misalignment with Q angle´s Exam [ Time Frame: 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) ]
    Q angle is formed between the border of the anterosuperior iliac spine, the center of the patella and the center of the tibia, measured in degrees.
  • Core strength with McGill´s Exam [ Time Frame: 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) ]
    The strength is the ability to generate maximum intramuscular tension before a resistance, regardless of whether or not it generates movement. McGill Exam used to assess the strenght of the core muscles.
  • Quadriceps and gluteus Strength with Squat´s Test [ Time Frame: 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) ]
    Squat Test is a field test, easy and simple to assess the Gluteus and quadriceps muscles strenght.
  • Tensor fascia lata Muscle Length with Ober´s Test [ Time Frame: Tensor fascia lata Muscle Length 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) ]
    Ober's test is used in physical examination to identify tightness of the iliotibial band (The test result is positive if the patient is unable to adduct the leg parallel to the table in a neutral position).
  • Hamstrings Muscle Length with Passive knee extension´s Test [ Time Frame: Hamstrings Muscle Length 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) ]
    The purpose of the Passive knee extension test is to examine the joint range, quality of movement and to measure tightness of the hamstring muscles (the knee angle is measure with a goniometer and represents the hamstring tightness).
  • Quadriceps Muscle Length with Ely´s Test [ Time Frame: Quadriceps Muscle Length 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) ]
    Ely's test or Duncan-Ely test is used to assess rectus femoris tightness (The test is positive when the heel can not touch the buttocks, the hip of the tested side rises up from the table, the patient feels pain or tingling in the back or legs).
  • Gastrocnemius Muscle Length with Weightbearing Measurement [ Time Frame: Gastrocnemius Muscle Length 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) ]
    The purpose of the Weight Measurement or the Wall Test is to measure the lack of mobility of the ankle or the narrowness of the gastrocnemius (if the test measures less than 11 cm, the ankle is generally thought to be lacking mobility or is shortened).
  • Static Balance with Single Leg stance [ Time Frame: Static Balance asessment 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) ]
    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).
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Therapeutic Effect of Two Muscle Strengthening Programs in Patients With Patellofemoral Pain Syndrome
Official Title  ICMJE TTherapeutic Effect of Two Muscle Strengthening Programs in Patients With Patellofemoral Pain Syndrome From Bogota, Colombia. Experimental Study, Clinical Controlled Trial
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).

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
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).
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description:
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.
Primary Purpose: Treatment
Condition  ICMJE Patellofemoral Pain Syndrome
Intervention  ICMJE 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

Study Arms  ICMJE
  • Experimental: Core, Hip and knee.
    Physical Exercises to strengthen the core, hip and knee.
    Intervention: Other: Strengthening program
  • Sham Comparator: Hip and Knee
    Physical Exercises to strengthen the hip and knee.
    Intervention: Other: Strengthening program
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 5, 2019)
40
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 13, 2019
Actual Primary Completion Date January 13, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 15 Years to 40 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Colombia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04011436
Other Study ID Numbers  ICMJE Patellofemoral Pain Syndrome
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
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.
Responsible Party Luisa Fernanda Prieto Garcia, Universidad Nacional de Colombia
Study Sponsor  ICMJE Universidad Nacional de Colombia
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Juan Alzate Granados Universidad Nacional de Colombia
PRS Account Universidad Nacional de Colombia
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP