Diacutaneous Fibrolysis and Patellofemoral Pain Syndrome

NCT ID: NCT02379364

Last Updated: 2017-05-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-05-31

Study Completion Date

2016-05-31

Brief Summary

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The aim of the study will be to assess the effectiveness of Diacutaneous Fibrolysis technique on pain, range of motion (Patellofemoral joint mobility test and muscle length test), strength and function in patients with Patellofemoral Pain Syndrome and muscle shortening.

Muscle imbalance is one of most important factor associated with Patellofemoral Pain Syndrome. Shortening of lateral muscles of the thigh have a close relationship with patella position and tracking and patellofemoral pain. The scientific evidence for effectiveness of any soft tissue mobilization technique in patellofemoral pain syndrome patients is poor.

Diacutaneous Fibrolysis is a non-invasive physiotherapeutic technique to release adherences and fibrosis between the different musculoskeletal structures. Diacutaneous Fibrolysis is applied by a set of metallic hooks having the advantage of allowing a deeper and more precise application, which could not be achieved manually.

The present study evaluates the effectiveness of Diacutaneous Fibrolysis technique applied in the soft tissues more related with patellofemoral pain.

Detailed Description

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Conditions

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Patellofemoral Pain Syndrome

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Intervention group

Diacutaneous Fibrolysis treatment

Group Type EXPERIMENTAL

Diacutaneous Fibrolysis

Intervention Type DEVICE

Diacutaneous Fibrolysis is a non invasive physiotherapeutic technique applied by means a set of metallic hooks having the advantage of allowing a deeper and more precise application, which could not be achieved manually

Interventions

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Diacutaneous Fibrolysis

Diacutaneous Fibrolysis is a non invasive physiotherapeutic technique applied by means a set of metallic hooks having the advantage of allowing a deeper and more precise application, which could not be achieved manually

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Unilateral or bilateral patellofemoral pain longer than three months
* Anterior or retropatellar pain of non-traumatic origin that is provoked by at least two of the following activities: prolonged sitting or kneeling, squatting, running, hopping, jumping, or stair ascending/descending.
* The presence of pain on palpation of the patellar facets, on step down from 25 cm step, or during a double leg squat.
* Pain over the previous week equal to or greater than 3 on a 10-cm visual analogue scale.
* The presence of muscle shortening in rectus femoris or tensor fascia lata muscle length test and/or hypo-mobility or stiffness in the compartmental muscle play.

Exclusion Criteria

* Previous knee surgery or traumatic lesions
* Concomitant injury or pathology of other knee structures
* History of patella subluxation or dislocation
* Evidence of knee joint effusion
* Pain in and/or referred from the hip or lumbar spine
* Currently undergoing physiotherapy treatment for Patellofemoral pain syndrome or use anti-inflammatories or corticosteroid medication at the same time of the study.
* Subjects unable or unwilling to give informed to written consent or fulfil questionnaires.
Minimum Eligible Age

16 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universidad de Zaragoza

OTHER

Sponsor Role lead

Responsible Party

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Pablo Fanlo Mazas

Unidad de Investigación en Fisioterapia

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Pablo Fanlo, PhD

Role: PRINCIPAL_INVESTIGATOR

Unidad de Investigación en Fisioterapia. Universidad de Zaragoza

Locations

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Unidad de Investigación en Fisioterapia. Universidad de Zaragoza

Zaragoza, , Spain

Site Status

Countries

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Spain

Other Identifiers

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PI/01

Identifier Type: -

Identifier Source: org_study_id

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