Diacutaneous Fibrolysis and Patellofemoral Pain Syndrome | NCT02379364

Studies
Diacutaneous Fibrolysis and Patellofemoral Pain Syndrome

NCT02379364

Sponsor

Universidad de Zaragoza

Status

Completed

Last Update Posted

May 11, 2017Actual

Enrollment

60Actual

Phase

Phase 3

Conditions

Patellofemoral Pain Syndrome

Interventions

Diacutaneous Fibrolysis

Countries

Spain

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2015

Primary Completion Date

Feb 2016Actual

Completion Date

May 2016Actual

First Submitted Date

Feb 9, 2015

First Submission Date that Met QC Criteria

Feb 26, 2015

First Posted Date

Mar 4, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 10, 2017

Last Update Posted Date

May 11, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Intervention group	Experimental	Diacutaneous Fibrolysis treatment	Device: Diacutaneous Fibrolysis

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Diacutaneous Fibrolysis	Device	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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change from baseline in pain intensity	Visual analogue scale (VAS)	2 weeks

Secondary Outcomes

Measure	Description	Time Frame
Pressure Pain Threshold	Pressure algometry	2 weeks
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

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

16 Years

Maximum Age

40 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Pablo Fanlo, PhD	Unidad de Investigación en Fisioterapia. Universidad de Zaragoza	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Unidad de Investigación en Fisioterapia. Universidad de Zaragoza		Zaragoza		50009	Spain

ID	Term
D007592	Joint Diseases
D009140	Musculoskeletal Diseases