Immediate Effects of Ankle Mobilization on Dorsiflexion Range of Motion in Women With Patellofemoral Pain. (Mestrado)

February 21, 2019 updated by: Gabriel Peixoto Leão Almeida, Universidade Federal do Ceara

Immediate Effects of Ankle Mobilization on Dorsiflexion Range of Motion in Closed Kinetic Chain in Women With Patellofemoral Pain: A Random Clinical Trial

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.

Study Overview

Status

Completed

Intervention / Treatment

Detailed Description

The sample of this study will be formed by 117 lower limbs of women with PFP who have ankle dorsoflexion restriction, divided into three groups. Each group will contain 39 lower limbs and receive an ankle mobilization technique with a specific sense of mobilization. The group nominated GAP will receive an mobilization technique with slip sense from anterior to posterior. The group nominated GPA will receive an mobilization technique with slip sense from posterior to anterior. The group nominated GPA-AP will receive an mobilization technique with slip sense both from posterior to anterior and from anterior to posterior.

Each group will receive a single intervention, which will consist of four sets of five repetitions of the ankle mobilization technique (according to the specific slip direction of each group), with rest time between series of one minute. In the group GPA-AP, to standardized the sequence of mobilization, the first two sets will be performed with slip sense from anterior to posterior, and the last two sets will be performede with slip sense from posterior to anterior. There will be randomisation allocation of individuals in the groups and because of the nature of the interventions only the evaluator may be blind.

The Kolmogorov - Smirnov test is used to verify the data distribution normality. The characterization of the participants is performed by means of descriptive statistical analysis. Parametric or non-parametric tests will be used according to the data distribution normality for comparison between groups at baseline. The evaluator blinding will be tested using the chi -square test by comparing the randomization code with the evaluator opinion. The difference between the groups and their respective confidence intervals will be calculated by linear mixed models using interaction term of "time versus group".

Study Type

Interventional

Enrollment (Actual)

117

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Ceará
      • Fortaleza, Ceará, Brazil, 60430-160
        • Federal University of Ceará

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 35 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Group from posterior to anterior (GPA)
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.
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.
Other Names:
  • Manual Physical Therapy
ACTIVE_COMPARATOR: Group from anterior to posterior (GAP)
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.
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.
Other Names:
  • Manual Physical Therapy
ACTIVE_COMPARATOR: Group GPA-AP
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.
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.
Other Names:
  • Manual Physical Therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Range of motion of ankle dorsiflexion.
Time Frame: Immediatly after intervention day.
Closed kinetic chain evaluation to find the greatest distance between the foot and the wall without compensations.
Immediatly after intervention day.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Range of motion of ankle dorsiflexion.
Time Frame: Two days after intervention day.
Closed kinetic chain evaluation to find the greatest distance between the foot and the wall without compensations.
Two days after intervention day.
Angle of projection in the frontal plane in the lower limb.
Time Frame: Immediatly and two days after intervention day.
Will be measured during the conduct of the Forward Step-Down Test through captured footage using a digital camera that will be positioned within two meters of the participant.
Immediatly and two days after intervention day.
Numeric Pain Scale.
Time Frame: Immediatly and two days after intervention day.
Pain was assessed by use of an Numeric Pain Scale of eleven point, where zero corresponded to no pain and ten corresponded to worst imaginable pain
Immediatly and two days after intervention day.
Global Effect Perception Scale for Treatment
Time Frame: Immediatly and two days after intervention day.
Global Effect Perception Scale for Treatment was assessed by use f an numeric scale of eleven point, where the lowest score corresponds to the extremely worst condition and the highest score corresponds to the fully recovered condition.
Immediatly and two days after intervention day.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Gabriel PL Almeida, MSc, Federal University of Ceará (UFC), Brazil.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 14, 2017

Primary Completion (ACTUAL)

March 31, 2018

Study Completion (ACTUAL)

September 25, 2018

Study Registration Dates

First Submitted

September 11, 2017

First Submitted That Met QC Criteria

September 11, 2017

First Posted (ACTUAL)

September 13, 2017

Study Record Updates

Last Update Posted (ACTUAL)

February 22, 2019

Last Update Submitted That Met QC Criteria

February 21, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • Mestrado_Bruno

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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