Diacutaneous Fibrolysis and Patellofemoral Pain Syndrome

Patellofemoral Pain Syndrome Clinical Trial

Official title:

Effectiveness of Diacutaneous Fibrolysis Technique on Pain, Range of Motion, Strength and Function in Patients With Patellofemoral Pain Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02379364
• Other study ID #: PI/01
• Status: Completed
• Phase: Phase 3
• First received: February 9, 2015
• Last updated: May 10, 2017
• Start date: May 2015
• Est. completion date: May 2016

Study information

• Verified date: May 2017
• Source: Universidad de Zaragoza
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: May 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Patellofemoral Pain Syndrome
• Somatoform Disorders
• Syndrome

Intervention

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

Locations

Country	Name	City	State
Spain	Unidad de Investigación en Fisioterapia. Universidad de Zaragoza	Zaragoza

Sponsors (1)

Lead Sponsor	Collaborator
Universidad de Zaragoza

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in pain intensity	Visual analogue scale (VAS)	2 weeks
Secondary	Pressure Pain Threshold	Pressure algometry	2 weeks
Secondary	Muscle Length Test	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	2 weeks
Secondary	Isometric Strength of Quadriceps Muscle	digital dynamometer	2 weeks
Secondary	Functional Capacity	Unilateral squat test and step test for assessing functional capacity	2 weeks
Secondary	Functional Status and disability	Anterior Knee Pain Scale	2 weeks
Secondary	Global Rating of Change Scale	global improvement on a five point Likert scale and visual analogue scale	2 weeks