Clinical trial NCT03281421: Immediate Effects of Ankle Mobilization on Dorsiflexion Range of Motion in Women With Patellofemoral Pain.
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Patellofemoral Pain Syndrome
Lead sponsor: Universidade Federal do Ceara
Sponsor class: OTHER
First posted: 2017-09-13
Enrollment: 117
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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".

Eligibility 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.

Primary outcomes:
measure: Range of motion of ankle dorsiflexion.
timeFrame: Immediatly after intervention day.
Secondary outcomes:
measure: Range of motion of ankle dorsiflexion.
timeFrame: Two days after intervention day.
measure: Angle of projection in the frontal plane in the lower limb.
timeFrame: Immediatly and two days after intervention day.
measure: Numeric Pain Scale.
timeFrame: Immediatly and two days after intervention day.
measure: Global Effect Perception Scale for Treatment
timeFrame: Immediatly and two days after intervention day.
Other outcomes:
Locations:
city: Fortaleza
country: Brazil
facility: Federal University of Ceara
state: Ceará
Study officials:
affiliation: Federal University of Ceará (UFC), Brazil.
name: Gabriel PL Almeida, MSc
role: PRINCIPAL_INVESTIGATOR
References: