Back to resultsDiacutaneous Fibrolysis and Patellofemoral Pain Syndrome
Primary Purpose
Patellofemoral Pain Syndrome
Status
Completed
Phase
Phase 3
Locations
Spain
Study Type
Interventional
Intervention
Diacutaneous Fibrolysis
Sponsored by
About this trial
This is an interventional treatment trial for Patellofemoral Pain Syndrome focused on measuring Physiotherapy, Patellofemoral Pain Syndrome, Manual therapy
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.
Sites / Locations
- Unidad de Investigación en Fisioterapia. Universidad de Zaragoza
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Intervention group
Arm Description
Diacutaneous Fibrolysis treatment
Outcomes
Primary Outcome Measures
Change from baseline in pain intensity
Visual analogue scale (VAS)
Secondary Outcome Measures
Pressure Pain Threshold
Pressure algometry
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
Isometric Strength of Quadriceps Muscle
digital dynamometer
Functional Capacity
Unilateral squat test and step test for assessing functional capacity
Functional Status and disability
Anterior Knee Pain Scale
Global Rating of Change Scale
global improvement on a five point Likert scale and visual analogue scale
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02379364
Brief Title
Diacutaneous Fibrolysis and Patellofemoral Pain Syndrome
Official Title
Effectiveness of Diacutaneous Fibrolysis Technique on Pain, Range of Motion, Strength and Function in Patients With Patellofemoral Pain Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
May 2015 (undefined)
Primary Completion Date
February 2016 (Actual)
Study Completion Date
May 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad de Zaragoza
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Patellofemoral Pain Syndrome
Keywords
Physiotherapy, Patellofemoral Pain Syndrome, Manual therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention group
Arm Type
Experimental
Arm Description
Diacutaneous Fibrolysis treatment
Intervention Type
Device
Intervention Name(s)
Diacutaneous Fibrolysis
Intervention Description
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
Primary Outcome Measure Information:
Title
Change from baseline in pain intensity
Description
Visual analogue scale (VAS)
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
Pressure Pain Threshold
Description
Pressure algometry
Time Frame
2 weeks
Title
Muscle Length Test
Description
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
Time Frame
2 weeks
Title
Isometric Strength of Quadriceps Muscle
Description
digital dynamometer
Time Frame
2 weeks
Title
Functional Capacity
Description
Unilateral squat test and step test for assessing functional capacity
Time Frame
2 weeks
Title
Functional Status and disability
Description
Anterior Knee Pain Scale
Time Frame
2 weeks
Title
Global Rating of Change Scale
Description
global improvement on a five point Likert scale and visual analogue scale
Time Frame
2 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pablo Fanlo, PhD
Organizational Affiliation
Unidad de Investigación en Fisioterapia. Universidad de Zaragoza
Official's Role
Principal Investigator
Facility Information:
Facility Name
Unidad de Investigación en Fisioterapia. Universidad de Zaragoza
City
Zaragoza
ZIP/Postal Code
50009
Country
Spain
12. IPD Sharing Statement
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Diacutaneous Fibrolysis and Patellofemoral Pain Syndrome
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