Diacutaneous Fibrolysis and Patellofemoral Pain Syndrome

Phase 3

Completed

• Conditions: Patellofemoral Pain Syndrome
• Interventions: Device: Diacutaneous Fibrolysis

• Registration Number: NCT02379364
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-02-09
• Study First Submitted QC: 2015-02-26
• Study First Posted: 2015-03-04
• Study Start: 2015-05
• Primary Completion: 2016-02
• Study Completion: 2016-05
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-10
• Last Update Posted: 2017-05-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intervention group	Diacutaneous Fibrolysis	Diacutaneous Fibrolysis treatment

Primary Outcome Measures

Name	Time	Method
Change from baseline in pain intensity	2 weeks	Visual analogue scale (VAS)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Unidad de Investigación en Fisioterapia. Universidad de Zaragoza; 🇪🇸 Zaragoza, Spain