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

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ClinicalTrials.gov Identifier: NCT03281421
Recruitment Status : Completed
First Posted : September 13, 2017
Last Update Posted : February 22, 2019
Sponsor:
Information provided by (Responsible Party):
Gabriel Peixoto Leão Almeida, Universidade Federal do Ceara

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.

Condition or disease Intervention/treatment Phase
Patellofemoral Pain Syndrome Other: Manual Therapy Not Applicable

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".

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 117 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Immediate Effects of Ankle Mobilization on Dorsiflexion Range of Motion in Closed Kinetic Chain in Women With Patellofemoral Pain: A Random Clinical Trial
Actual Study Start Date : September 14, 2017
Actual Primary Completion Date : March 31, 2018
Actual Study Completion Date : September 25, 2018

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.
Other: Manual Therapy
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 Name: 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.
Other: Manual Therapy
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 Name: 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.
Other: Manual Therapy
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 Name: Manual Physical Therapy




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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

  4. 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.



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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03281421


Locations
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Brazil
Federal University of Ceara
Fortaleza, Ceará, Brazil, 60430-160
Sponsors and Collaborators
Universidade Federal do Ceara
Investigators
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Principal Investigator: Gabriel PL Almeida, MSc Federal University of Ceará (UFC), Brazil.
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Responsible Party: Gabriel Peixoto Leão Almeida, Professor, Universidade Federal do Ceara
ClinicalTrials.gov Identifier: NCT03281421    
Other Study ID Numbers: Mestrado_Bruno
First Posted: September 13, 2017    Key Record Dates
Last Update Posted: February 22, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Patellofemoral Pain Syndrome
Joint Diseases
Musculoskeletal Diseases