NCT02379364

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started May 2015

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 9, 2015

Completed
23 days until next milestone

First Posted

Study publicly available on registry

March 4, 2015

Completed
2 months until next milestone

Study Start

First participant enrolled

May 1, 2015

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
Last Updated

May 11, 2017

Status Verified

May 1, 2017

Enrollment Period

9 months

First QC Date

February 9, 2015

Last Update Submit

May 10, 2017

Conditions

Patellofemoral Pain Syndrome

Keywords

PhysiotherapyPatellofemoral Pain SyndromeManual therapy

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in pain intensity

    Visual analogue scale (VAS)

    2 weeks

Secondary Outcomes (6)

  • Pressure Pain Threshold

    2 weeks

  • Muscle Length Test

    2 weeks

  • Isometric Strength of Quadriceps Muscle

    2 weeks

  • Functional Capacity

    2 weeks

  • Functional Status and disability

    2 weeks

  • +1 more secondary outcomes

Study Arms (1)

Intervention group

EXPERIMENTAL

Diacutaneous Fibrolysis treatment

Device: Diacutaneous Fibrolysis

Interventions

Diacutaneous FibrolysisDEVICE

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 group

Eligibility Criteria

Age16 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unidad de Investigación en Fisioterapia. Universidad de Zaragoza

Zaragoza, 50009, Spain

Location

MeSH Terms

Conditions

Patellofemoral Pain Syndrome

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal Diseases

Study Officials

  • Pablo Fanlo, PhD

    Unidad de Investigación en Fisioterapia. Universidad de Zaragoza

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Unidad de Investigación en Fisioterapia

Study Record Dates

First Submitted

February 9, 2015

First Posted

March 4, 2015

Study Start

May 1, 2015

Primary Completion

February 1, 2016

Study Completion

May 1, 2016

Last Updated

May 11, 2017

Record last verified: 2017-05

Locations

ES(1)