Patellofemoral Pain SyndromePhase 3NCT02379364

Diacutaneous Fibrolysis and Patellofemoral Pain Syndrome

A Phase 3 study testing Diacutaneous Fibrolysis in people with Patellofemoral Pain Syndrome, run by Universidad de Zaragoza at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

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. Read more about this study

Who is it for?: Ages 16 to 40 years
Conditions the study is for: Patellofemoral Pain Syndrome
What is being tested?: Diacutaneous Fibrolysis
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 60 participants
Where: 1 siteSpain
Study dates: May 2015to May 2016
Phase: Phase 3
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 16 to 40 years
All sexes
No healthy volunteers
Child, Adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

Spain1 site

Unidad de Investigación en Fisioterapia. Universidad de Zaragoza
Zaragoza, 50009

Other trials in Spain

About this study

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

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.

Conditions: Patellofemoral Pain Syndrome
Being tested: Diacutaneous Fibrolysis
Keywords: Physiotherapy, Patellofemoral Pain Syndrome, Manual therapy
Medical subject headings: Patellofemoral Pain Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT02379364
Study group	Role	What they receive
Intervention group	Experimental	Diacutaneous Fibrolysis treatment Receives: Device: Diacutaneous Fibrolysis

What is being measured

The primary outcome is the main question the study is designed to answer.

Change from baseline in pain intensity
Visual analogue scale (VAS)
Measured: 2 weeks

Secondary outcomes (6)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2015May 2016

First posted4 Mar 2015 (estimated)
Study startMay 2015
Primary completionFeb 2016
Study completionMay 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Patellofemoral Pain SyndromeStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 60 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02379364
Sponsor's protocol ID: PI/01
Status last verified: May 2017
First submitted: 9 Feb 2015
Last updated: 11 May 2017
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
Effects of Telerehabilitation Versus Supervised Rehabilitation Protocol on Pain, Range of Motion and Functional Recovery in Patients With Patellofemoral Pain Syndrome.
Patello Femoral Pain Syndrome
RecruitingObservational study
MRI Study of Musculoskeletal Function
Abnormalities, Imaging
Not yet recruiting
Comparison of High-Intensity and Conventional Physical Therapy in Musculoskeletal Disorders
Low Back Pain, Radicular Syndrome
Active, not recruiting
Stabilization vs Corrective Exercise in PFP
Patellofemoral Pain Syndrome
Not yet recruiting
Effectiveness of Selected Traditional Chinese Medicine Topical Agents on Long Distance Runner Versus Exercise Therapy as Control for Patellofemoral Pain Syndrome
Patellar Femoral Syndrome, TCMO (Ng's Prescription)

All Patellofemoral Pain Syndrome trials

Study at a glance

From the registry record, last updated by the sponsor on 11 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effectiveness of Diacutaneous Fibrolysis Technique on Pain, Range of Motion, Strength and Function in Patients With Patellofemoral Pain Syndrome
ClinicalTrials.gov ID: NCT02379364
Acronym / sponsor ID: PI/01
Conditions: Patellofemoral Pain Syndrome
Keywords: Physiotherapy, Patellofemoral Pain Syndrome, Manual therapy
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 60 participants (actual)
Lead sponsor: Universidad de ZaragozaUniversity, hospital or other
Study start: May 2015
Primary completion: Feb 2016 (actual)
Study completion: May 2016 (actual)
First posted: 4 Mar 2015 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The present study evaluates the effectiveness of Diacutaneous Fibrolysis technique applied in the soft tissues more related with patellofemoral pain.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Intervention group	Experimental	Device: Diacutaneous FibrolysisDiacutaneous Fibrolysis treatment

Who may qualify

Ages: 16 to 40 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult

Key inclusion criteria (5 listed)

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.

Key exclusion criteria (7 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Diacutaneous FibrolysisDiacutaneous 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	Device	Intervention group

Primary outcome

Change from baseline in pain intensity
Time frame: 2 weeks
Visual analogue scale (VAS)

6 secondary outcomes

Pressure Pain Threshold
Time frame: 2 weeks
Muscle Length Test
Time frame: 2 weeks
Isometric Strength of Quadriceps Muscle
Time frame: 2 weeks
Functional Capacity
Time frame: 2 weeks
Functional Status and disability
Time frame: 2 weeks
Global Rating of Change Scale
Time frame: 2 weeks

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2017.

Related trials for Patellofemoral Pain Syndrome

Recruiting
Effects of Telerehabilitation Versus Supervised Rehabilitation Protocol on Pain, Range of Motion and Functional Recovery in Patients With Patellofemoral Pain Syndrome.
Patello Femoral Pain Syndrome
RecruitingObservational study
MRI Study of Musculoskeletal Function
Abnormalities, Imaging
Not yet recruiting
Comparison of High-Intensity and Conventional Physical Therapy in Musculoskeletal Disorders
Low Back Pain, Radicular Syndrome
Active, not recruiting
Stabilization vs Corrective Exercise in PFP
Patellofemoral Pain Syndrome
Not yet recruiting
Effectiveness of Selected Traditional Chinese Medicine Topical Agents on Long Distance Runner Versus Exercise Therapy as Control for Patellofemoral Pain Syndrome
Patellar Femoral Syndrome, TCMO (Ng's Prescription)

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Pablo Fanlo, PhD principal investigator

Unidad de Investigación en Fisioterapia. Universidad de Zaragoza

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Diacutaneous Fibrolysis in people with Patellofemoral Pain Syndrome, run by Universidad de Zaragoza at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 May 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline in pain intensity (time frame: 2 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02379364.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2017.