NCT03281421

Brief Summary

Anterior Knee Pain or Patellofemoral Pain (PFP) is one of the most common disorders that affecting knee in the physically active population, being a condition that typically presents as diffuse knee pain in the anterior region and retro- or peri-patellar area, mainly in activities that increase compression force in patellofemoral joint, such as squatting, running, stair ascent and descent. The overall prevalence of PFP has been reported as between 15-45% of the population, and its incidence is higher among women. The literature cites as etiology of PFP the ocorrence of dysfunctions in the local (knee), proximal (trunk, pelvis and hip complex) and distal (ankle and foot regions) factores. Actually, there is a lack of studies that investigate the interventions influences on distal factors in outcomes clinical in persons with PFP. Thus, the aim of this study is analyze the effect of ankle mobilization techiniques in ankle dorsiflexion range of motion closed kinetic chain in women with patellofemoral pain and with dorsoflexion restriction.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
117

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 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

September 11, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 13, 2017

Completed
1 day until next milestone

Study Start

First participant enrolled

September 14, 2017

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2018

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 25, 2018

Completed
Last Updated

February 22, 2019

Status Verified

February 1, 2019

Enrollment Period

7 months

First QC Date

September 11, 2017

Last Update Submit

February 21, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • Range of motion of ankle dorsiflexion.

    Closed kinetic chain evaluation to find the greatest distance between the foot and the wall without compensations.

    Immediatly after intervention day.

Secondary Outcomes (4)

  • Range of motion of ankle dorsiflexion.

    Two days after intervention day.

  • Angle of projection in the frontal plane in the lower limb.

    Immediatly and two days after intervention day.

  • Numeric Pain Scale.

    Immediatly and two days after intervention day.

  • Global Effect Perception Scale for Treatment

    Immediatly and two days after intervention day.

Study Arms (3)

Group from posterior to anterior (GPA)

EXPERIMENTAL

Participants in group GPA will receive a manual therapy intervention, through the technique of mobilization with movement in the ankle joint, with a slip sense from posterior to anterior. The physiotherapist will be positioned in front the participant's ankle, and a belt will be posicioned above the participant's malleolus and around physiotherapist's pelvis. The therapist applies with belt a anterior slip sustained in the tibia of the participant, while the talus are secured with the space between the thumb and the second finger of the hand of both hands on the physiotherapist´s. The participant will be instructed to perform a slow dorsiflexion movement at its maximum amplitude and hold five seconds in that position, returning to the initial position at the end of the five seconds.

Other: Manual Therapy

Group from anterior to posterior (GAP)

ACTIVE COMPARATOR

Participants in group GAP will receive a manual therapy intervention, through the technique of mobilization with movement in the ankle joint, with a slip sense from anterior to posterior. The physiotherapist will be positioned behind the participant's ankle. An belt will be posicioned above the participant's malleolus and around physiotherapist's trunk. The therapist applies with belt a posterior slip sustained in the tibia of the participant, while the heel and rearfoot are secured with the space between the thumb and the second finger of the hand of both hands on the physiotherapist´s. The participant will be instructed to perform a slow dorsiflexion movement at its maximum amplitude and hold five seconds in that position, returning to the initial position at the end of the five seconds.

Other: Manual Therapy

Group GPA-AP

ACTIVE COMPARATOR

Participants in group GAP will receive a manual therapy intervention, through the technique of mobilization with movement in the ankle joint, with a slip sense both from posterior to anterior and anterior to posterior. In the group GPA-AP, will be apllied both the procedure described for the group GPA as for the group GAP. To standardized the sequence of mobilization, the first two sets will be performed with slip sense from posterior to anterior, and the last two sets will be performede with slip sense from anterior to posterior.

Other: Manual Therapy

Interventions

The manual therapy intervention, through the technique of mobilization with movement in the ankle joint (following the specific sense direction of the group), will be performed in a protocol that consists of four sets of five repetitions, with rest time between series of one minute.

Also known as: Manual Physical Therapy
Group GPA-APGroup from anterior to posterior (GAP)Group from posterior to anterior (GPA)

Eligibility Criteria

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

You may qualify if:

  • Presence of localized pain in the anterior region of the knee and / or around the patella, reproduced with at least two of the following activities: climbing / descending stairs, crouching, kneeling, long sitting, isometric contraction of the quadriceps, running and jump.
  • Existence of a report of pain for at least three months, beginning incidental and unrelated to some traumatic event in the knee.
  • Pain with intensity of at least three points in the Visual Analogue Scale (VAS) of pain in the last week.
  • Limitation of the ankle dorsiflexion range of motion measured by the Lunge Test in the lower limb with Patellofemoral Pain.

You may not qualify if:

  • History of surgery in the lumbar spine, hip, knee and / or ankle;
  • History of fractures in the lumbar spine, hip, knee and / or ankle;
  • History of patellar dislocation;
  • Presence of edema in the knee joint;
  • Presence of meniscal injury;
  • Injury of cruciate ligament and / or collateral ligaments;
  • Presence of tendonopathy in the patellar tendon, tendons of the goose and / or band leg tibial ilium;
  • Presence of Osgood-Schlatter Syndrome or Sinding-Larsen-Johansson Syndromes.
  • Presence of pain in the lumbar spine and / or 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

Interventions

Musculoskeletal Manipulations

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Officials

  • Gabriel PL Almeida, MSc

    Federal University of Ceará (UFC), Brazil.

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

September 11, 2017

First Posted

September 13, 2017

Study Start

September 14, 2017

Primary Completion

March 31, 2018

Study Completion

September 25, 2018

Last Updated

February 22, 2019

Record last verified: 2019-02

Data Sharing

IPD Sharing
Will not share

Locations