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Diacutaneous Fibrolysis and Patellofemoral Pain Syndrome

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ClinicalTrials.gov Identifier: NCT02379364
Recruitment Status : Completed
First Posted : March 4, 2015
Last Update Posted : May 11, 2017
Sponsor:
Information provided by (Responsible Party):
Pablo Fanlo Mazas, Universidad de Zaragoza

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Patellofemoral Pain Syndrome Device: Diacutaneous Fibrolysis Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effectiveness of Diacutaneous Fibrolysis Technique on Pain, Range of Motion, Strength and Function in Patients With Patellofemoral Pain Syndrome
Study Start Date : May 2015
Actual Primary Completion Date : February 2016
Actual Study Completion Date : May 2016

Arm Intervention/treatment
Experimental: Intervention group
Diacutaneous Fibrolysis treatment
Device: 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




Primary Outcome Measures :
  1. Change from baseline in pain intensity [ Time Frame: 2 weeks ]
    Visual analogue scale (VAS)


Secondary Outcome Measures :
  1. Pressure Pain Threshold [ Time Frame: 2 weeks ]
    Pressure algometry

  2. Muscle Length Test [ Time Frame: 2 weeks ]
    Range of motion measured by digital inclinometer in hip adduction for iliotibial band, knee flexion for rectus femoris muscle and knee extension for hamstrings muscles

  3. Isometric Strength of Quadriceps Muscle [ Time Frame: 2 weeks ]
    digital dynamometer

  4. Functional Capacity [ Time Frame: 2 weeks ]
    Unilateral squat test and step test for assessing functional capacity

  5. Functional Status and disability [ Time Frame: 2 weeks ]
    Anterior Knee Pain Scale

  6. Global Rating of Change Scale [ Time Frame: 2 weeks ]
    global improvement on a five point Likert scale and visual analogue scale



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Ages Eligible for Study:   16 Years to 40 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

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): NCT02379364


Locations
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Spain
Unidad de Investigación en Fisioterapia. Universidad de Zaragoza
Zaragoza, Spain, 50009
Sponsors and Collaborators
Universidad de Zaragoza
Investigators
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Principal Investigator: Pablo Fanlo, PhD Unidad de Investigación en Fisioterapia. Universidad de Zaragoza

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Responsible Party: Pablo Fanlo Mazas, Unidad de Investigación en Fisioterapia, Universidad de Zaragoza
ClinicalTrials.gov Identifier: NCT02379364     History of Changes
Other Study ID Numbers: PI/01
First Posted: March 4, 2015    Key Record Dates
Last Update Posted: May 11, 2017
Last Verified: May 2017

Keywords provided by Pablo Fanlo Mazas, Universidad de Zaragoza:
Physiotherapy
Patellofemoral Pain Syndrome
Manual therapy

Additional relevant MeSH terms:
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Syndrome
Somatoform Disorders
Patellofemoral Pain Syndrome
Disease
Pathologic Processes
Mental Disorders
Joint Diseases
Musculoskeletal Diseases