Diacutaneous Fibrolysis and Patellofemoral Pain Syndrome

Sponsor

Universidad de Zaragoza (Other)

Overall Status

Completed

CT.gov ID

NCT02379364

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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

Study Design

Study Type:

Interventional

Actual Enrollment :

60 participants

Allocation:

N/A

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 1, 2015

Actual Primary Completion Date :

Feb 1, 2016

Actual Study Completion Date :

May 1, 2016

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Change from baseline in pain intensity [2 weeks]
Visual analogue scale (VAS)

Secondary Outcome Measures

Pressure Pain Threshold [2 weeks]
Pressure algometry
Muscle Length Test [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
Isometric Strength of Quadriceps Muscle [2 weeks]
digital dynamometer
Functional Capacity [2 weeks]
Unilateral squat test and step test for assessing functional capacity
Functional Status and disability [2 weeks]
Anterior Knee Pain Scale
Global Rating of Change Scale [2 weeks]
global improvement on a five point Likert scale and visual analogue scale

Eligibility Criteria

Criteria

Ages Eligible for Study:

16 Years to 40 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.