NCT03163290

Brief Summary

Patellofemoral Pain (PFP) is one of the most common disorders that affecting the physically active population, and its incidence is higher among women. Despite the high incidence, the etiologies of this painful syndrome are still unclear. Research has verified the influence of hip stabilizers on knee injurie and has demonstrated a deficit of strength of the hip lateral rotator, abductors and extensors muscles in patients with PFP. The aim of this study is to compare the effectiveness of strengthening the Posterolateral Hip Complex with the Anteromedial Hip Complex associated with quadriceps strengthening for pain reduction and improvement of functional capacity in patients with PFP.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 19, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 23, 2017

Completed
20 days until next milestone

Study Start

First participant enrolled

June 12, 2017

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 12, 2017

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 12, 2019

Completed
Last Updated

July 21, 2020

Status Verified

July 1, 2020

Enrollment Period

5 months

First QC Date

May 19, 2017

Last Update Submit

July 17, 2020

Conditions

Outcome Measures

Primary Outcomes (2)

  • Numeric Pain Scale

    Pain was assessed by use of an 11-point Numeric Pain Scale, where 0 corresponded to no pain and 10 corresponded to worst imaginable pain. to worst imaginable pain.

    Six weeks

  • Anterior Knee Pain Scale

    Anterior Knee Pain Scale assesses functional capacity and pain level during functional and specific activities for patients with PFP. This scale was translated and culturally adapted to the Brazilian Portuguese language,10 and the score ranges from 0 (worst) to 100 (best).

    Six weeks

Secondary Outcomes (7)

  • Numeric Pain Scale

    Six months

  • Anterior Knee Pain Scale

    Six months

  • Numeric Pain Scale on Step Down Test

    Six weeks

  • Dynamic Knee Valgus on Frontal Plane Projection Angle

    Six weeks

  • Global Effect Perception Scale

    Six weeks

  • +2 more secondary outcomes

Study Arms (2)

Posterolateral Hip Complex Exercises

EXPERIMENTAL

The intervention protocol will be composed of: Heating, lower limb stretching, strengthening the quadriceps, and hip abductors, lateral rotators and extensors. Posterolateral Hip Complex Exercises add extension knee in open kinetic chain, squat , abduction exercise, Clam exercise and external rotation exercise. Physiotherapy treatment sessions will last for an average of one hour, twice a week, for a period of six weeks.

Other: Posterolateral Hip Complex Exercises

Anteromedial Hip Complex Exercises

ACTIVE COMPARATOR

The intervention protocol will be composed of: Heating, lower limb stretching, strengthening the quadriceps, and hip aductors, medial rotators and flexors. Anteromedial Hip Complex Exercises add extension knee in open kinetic chain, squat ,hip adduction exercise, adduction with a ring between the thighs and internal rotation exercise. Physiotherapy treatment sessions will last for an average of one hour, twice a week, for a period of six weeks.

Other: Anteromedial Hip Complex Exercises

Interventions

The treatment protocol was composed of: Heating, lower limb stretching, strengthening the quadriceps e hip muscles. The following exercises were included: abduction exercise, Clam exercise and external rotation exercise

Posterolateral Hip Complex Exercises

The treatment protocol was composed of: Heating, lower limb stretching, strengthening the quadriceps e hip muscles. The following exercises were included: hip adduction exercise, adduction with a ring between the thighs and internal rotation exercise.

Anteromedial Hip Complex Exercises

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Practicing physical activity for at least 3 times a week for at least 30 minutes;
  • Pain localized specifically around the patellofemoral joint, pain reproduced or reported in at least two of the following criteria: up or down stairs, squatting, kneeling, sitting for a long time, isometric contraction of the quadriceps, jumping, running and pain on palpation of the lateral and / or medial facet of the patella;
  • Report pain of insidious onset and lasting at least three months;
  • Pain at least three in the Numerical Pain Scale during the last week;
  • Report a maximum of 86 points on the Anterior Knee Pain Scale (maximum = 100 points).

You may not qualify if:

  • Previous surgery on the hip, knee, ankle and / or spine;
  • History of patellar dislocation;
  • Clinical evidence of knee instability (anterior and posterior drawer test, Lachman, varus and valgus stress);
  • Meniscal lesions or intra-articular lesions;
  • Evidence of edema;
  • Osgood-Schlatter syndrome or Sinding-Larsen-Johansson;
  • Patellar tendinopathy;
  • Chondral lesion;
  • Osteoarthritis;
  • Muscle or joint injuries to the hip.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Federal University of Ceara

Fortaleza, Ceará, 60430-160, Brazil

Location

MeSH Terms

Conditions

Patellofemoral Pain Syndrome

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal Diseases

Study Officials

  • Gabriel PL Almeida, MSc

    Universidade Federal do Ceara

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 19, 2017

First Posted

May 23, 2017

Study Start

June 12, 2017

Primary Completion

November 12, 2017

Study Completion

March 12, 2019

Last Updated

July 21, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share

IPD will not be shared.

Locations