Shock Wave Therapy Versus Neuromuscular Training in Women With Patellofemoral Pain

October 24, 2017 updated by: Piotr Michalik, Medical University of Silesia
The aim of the trial is to compare the efficacy of extracorporeal shock wave therapy (ESWT) versus neuromuscular training (TR) in reducing pain in women with patellofemoral pain (PFP). Women with PFP will be randomly divided into two therapeutic groups: ESWT and TR. The ESWT group will undergo extracorporeal shock wave therapy to the iliotibial band and tensor fascia latae. The TR group will be treated with neuromuscular training. The women's gait will be analysed and the strength of hip abductors and internal rotators will be measured. Additionally, the women's pain and health status will be assessed with the visual analogue scale and the Lysholm Scale. Outcomes will be registered at baseline, and then at five weeks and at three months post-therapy

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Poland
    • Śląskie
      • Katowice, Śląskie, Poland, 40-752
        • Recruiting
        • Department of Kinesitherapy and Special Methods, SHS in Katowice, Medical University of Silesia, Katowice, Poland

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 30 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

Knee pain for more than three months greater than three on the visual analogue scale (VAS) during at least two out of four typical activities:

  1. ascending or descending the stairs,
  2. prolonged sitting with flexed knee,
  3. running or jumping,
  4. squatting or kneeling.

Exclusion Criteria:

  1. Orthopaedic diagnosis other than PFP.
  2. Patients with neurological disorders, history of injury or operations within the symptomatic leg, rheumatoid disease, or pregnancy were also excluded from the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Neuromuscular Training
Each session lasted 30 minutes and consisted of three sets of exercises with 20-30 repetitions. Emphasis is placed on proper knee alignment during exercise. Most of the women exhibit excessive medial rotation and adduction of the femur, resulting in knee valgus. The women will be instructed how to correct their abnormalities using mirrors as visual feedback. All exercises will be completed without pain. If the exercises are too easy, the level of difficulty will be increased individually in accordance with the rehabilitation protocol
Other: Neuromuscular Training
Each session lasted 30 minutes and consisted of three sets of exercises with 20-30 repetitions. Emphasis was placed on proper knee alignment during exercise. Most of the women exhibited excessive medial rotation and adduction of the femur, resulting in knee valgus, although knee varus was also observed. The women were instructed how to correct their abnormalities using mirrors as visual feedback. All exercises were completed without pain. If the exercises were too easy, the level of difficulty was increased individually in accordance with the rehabilitation protocol
Active Comparator: Shock Wave Therapy
The ESWT group will will meet the therapist twice in the first week, and once a week after it. ESWT will be applied to the iliotibial band and tensor fascia latae with the following parameters: pressure - 4.5 bar, emission frequency -8 Hz, number of pulses per dose -2,500 per session.
Other: Extracorporeal Shock Wave Therapy (ESWT)
ESWT will be applied to the iliotibial band and tensor fascia latae muscle with the following parameters: pressure - 4.5 bar, emission frequency -8 Hz, number of pulses per dose -2,500 per session

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Visual Analog Scale is used to assess the subjective Pain.
Time Frame: Outcome measures are obtained at baseline (pre-intervention)
The participants are asked to make a mark on a 10 cm line that corresponds to the perceived maximal pain, peripatellar or retropatellar, they experienced during any activity or position (0 = no pain, 10 = the worst pain possible)
Outcome measures are obtained at baseline (pre-intervention)
Visual Analog Scale is used to assess the subjective Pain.
Time Frame: Outcome measures are obtained, at five weeks after intervention.
The participants are asked to make a mark on a 10 cm line that corresponds to the perceived maximal pain, peripatellar or retropatellar, they experienced during any activity or position (0 = no pain, 10 = the worst pain possible)
Outcome measures are obtained, at five weeks after intervention.
Visual Analog Scale is used to assess the subjective Pain.
Time Frame: Outcome measures are obtained at three months after intervention
The participants are asked to make a mark on a 10 cm line that corresponds to the perceived maximal pain, peripatellar or retropatellar, they experienced during any activity or position (0 = no pain, 10 = the worst pain possible)
Outcome measures are obtained at three months after intervention

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Gait analysis using the Zebris FDM-TDL instrumented treadmill with pressure sensors.
Time Frame: Outcome measures are obtained at baseline (pre-intervention)
The women walk on the treadmill barefoot for three minutes in order to become accustomed to the speed belt. After that time, the angles of the joints are measured for 30 seconds. Internal rotation is demarcated at the highest peak in midstance when the contralateral limb is in the terminal stance (toe-off phase). Hip adduction is determined at the highest peak in midstance
Outcome measures are obtained at baseline (pre-intervention)
Gait analysis using the Zebris FDM-TDL instrumented treadmill with pressure sensors.
Time Frame: Outcome measures are obtained, at five weeks after intervention.
The women walk on the treadmill barefoot for three minutes in order to become accustomed to the speed belt. After that time, the angles of the joints are measured for 30 seconds. Internal rotation is demarcated at the highest peak in midstance when the contralateral limb is in the terminal stance (toe-off phase). Hip adduction is determined at the highest peak in midstance
Outcome measures are obtained, at five weeks after intervention.
Gait analysis using the Zebris FDM-TDL instrumented treadmill with pressure sensors.
Time Frame: Outcome measures are obtained at three months after intervention
The women walk on the treadmill barefoot for three minutes in order to become accustomed to the speed belt. After that time, the angles of the joints are measured for 30 seconds. Internal rotation is demarcated at the highest peak in midstance when the contralateral limb is in the terminal stance (toe-off phase). Hip adduction is determined at the highest peak in midstance
Outcome measures are obtained at three months after intervention
Muscle strength is tested using the Micro Fet Handheld Dynamometer.
Time Frame: Outcome measures are obtained at baseline (pre-intervention)
Muscle strength of lateral rotators, abductors of the hip is tested. Three repetitions of muscle strength testing are performed with two 30-second intervals. The participants a of re asked to press against the Dynamometer with the maximum effort for 5-7 seconds.
Outcome measures are obtained at baseline (pre-intervention)
Muscle strength is tested using the Micro Fet Handheld Dynamometer.
Time Frame: Outcome measures are obtained, at five weeks after intervention.
Muscle strength of lateral rotators, abductors of the hip is tested. Three repetitions of muscle strength testing are performed with two 30-second intervals. The participants a of re asked to press against the Dynamometer with the maximum effort for 5-7 seconds.
Outcome measures are obtained, at five weeks after intervention.
Muscle strength is tested using the Micro Fet Handheld Dynamometer.
Time Frame: Outcome measures are obtained at three months after intervention
Muscle strength of lateral rotators, abductors of the hip is tested. Three repetitions of muscle strength testing are performed with two 30-second intervals. The participants a of re asked to press against the Dynamometer with the maximum effort for 5-7 seconds.
Outcome measures are obtained at three months after intervention
The self-reported health status is measured using the Lysholm Questionaire (LQ)
Time Frame: Outcome measures are obtained at baseline (pre-intervention)
The participants are asked to complete the eight-item questionnaire, scored on a 0-100 weighted scale
Outcome measures are obtained at baseline (pre-intervention)
The self-reported health status is measured using the Lysholm Questionaire (LQ)
Time Frame: Outcome measures are obtained, at five weeks after intervention.
The participants are asked to complete the eight-item questionnaire, scored on a 0-100 weighted scale
Outcome measures are obtained, at five weeks after intervention.
The self-reported health status is measured using the Lysholm Questionaire (LQ)
Time Frame: Outcome measures are obtained at three months after intervention
The participants are asked to complete the eight-item questionnaire, scored on a 0-100 weighted scale
Outcome measures are obtained at three months after intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Medical University of Silesia

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Mgdalena Dabrowska-Galas, PhD, Department of Kinesitherapy and Special Methods, SHS in Katowice, Medical University of Silesia, Katowice, Poland

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2014

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2018

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 18, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 24, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 27, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 27, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 24, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • kolanostudentki

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

The datasets used and/or analysed during the current study will be available from the corresponding author on reasonable request.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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