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Completed

NCT Number: NCT02379364

Diacutaneous Fibrolysis and Patellofemoral Pain Syndrome

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.

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Key information

Age range

16 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Unidad de Investigación en Fisioterapia. Universidad de Zaragoza

Zaragoza, 50009, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Primary outcomes

  1. Change from baseline in pain intensity

    Time frame: 2 weeks

    Visual analogue scale (VAS)

Secondary outcomes

  1. Pressure Pain Threshold

    Time frame: 2 weeks

    Pressure algometry

  2. Muscle Length Test

    Time frame: 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

  3. Isometric Strength of Quadriceps Muscle

    Time frame: 2 weeks

    digital dynamometer

  4. Functional Capacity

    Time frame: 2 weeks

    Unilateral squat test and step test for assessing functional capacity

  5. Functional Status and disability

    Time frame: 2 weeks

    Anterior Knee Pain Scale

  6. Global Rating of Change Scale

    Time frame: 2 weeks

    global improvement on a five point Likert scale and visual analogue scale

Sponsors and collaborators

Lead sponsor

Universidad de Zaragoza

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Mar 4, 2015
Registry last updated
May 11, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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