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Shock Wave Therapy Versus Neuromuscular Training in Women With Patellofemoral Pain

Primary Purpose

Patellofemoral Pain Syndrome, Knee Pain Chronic

Status
Unknown status
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
Neuromuscular Training
Extracorporeal Shock Wave Therapy (ESWT)
Sponsored by
Medical University of Silesia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Patellofemoral Pain Syndrome

Eligibility Criteria

18 Years - 30 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Department of Kinesitherapy and Special Methods, SHS in Katowice, Medical University of Silesia, Katowice, PolandRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Neuromuscular Training

Shock Wave Therapy

Arm Description

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

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.

Outcomes

Primary Outcome Measures

Visual Analog Scale is used to assess the subjective Pain.
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)
Visual Analog Scale is used to assess the subjective Pain.
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)
Visual Analog Scale is used to assess the subjective Pain.
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)

Secondary Outcome Measures

Gait analysis using the Zebris FDM-TDL instrumented treadmill with pressure sensors.
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
Gait analysis using the Zebris FDM-TDL instrumented treadmill with pressure sensors.
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
Gait analysis using the Zebris FDM-TDL instrumented treadmill with pressure sensors.
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
Muscle strength is tested using the Micro Fet Handheld Dynamometer.
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.
Muscle strength is tested using the Micro Fet Handheld Dynamometer.
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.
Muscle strength is tested using the Micro Fet Handheld Dynamometer.
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.
The self-reported health status is measured using the Lysholm Questionaire (LQ)
The participants are asked to complete the eight-item questionnaire, scored on a 0-100 weighted scale
The self-reported health status is measured using the Lysholm Questionaire (LQ)
The participants are asked to complete the eight-item questionnaire, scored on a 0-100 weighted scale
The self-reported health status is measured using the Lysholm Questionaire (LQ)
The participants are asked to complete the eight-item questionnaire, scored on a 0-100 weighted scale

Full Information

First Posted
July 18, 2017
Last Updated
October 24, 2017
Sponsor
Medical University of Silesia
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1. Study Identification

Unique Protocol Identification Number
NCT03324204
Brief Title
Shock Wave Therapy Versus Neuromuscular Training in Women With Patellofemoral Pain
Official Title
Shock Wave Therapy Versus Neuromuscular Training in Women With Patellofemoral Pain
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Unknown status
Study Start Date
August 1, 2014 (Actual)
Primary Completion Date
June 1, 2018 (Anticipated)
Study Completion Date
January 1, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of Silesia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Patellofemoral Pain Syndrome, Knee Pain Chronic

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Neuromuscular Training
Arm Type
Experimental
Arm Description
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
Arm Title
Shock Wave Therapy
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Neuromuscular Training
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Extracorporeal Shock Wave Therapy (ESWT)
Intervention Description
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
Primary Outcome Measure Information:
Title
Visual Analog Scale is used to assess the subjective Pain.
Description
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)
Time Frame
Outcome measures are obtained at baseline (pre-intervention)
Title
Visual Analog Scale is used to assess the subjective Pain.
Description
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)
Time Frame
Outcome measures are obtained, at five weeks after intervention.
Title
Visual Analog Scale is used to assess the subjective Pain.
Description
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)
Time Frame
Outcome measures are obtained at three months after intervention
Secondary Outcome Measure Information:
Title
Gait analysis using the Zebris FDM-TDL instrumented treadmill with pressure sensors.
Description
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
Time Frame
Outcome measures are obtained at baseline (pre-intervention)
Title
Gait analysis using the Zebris FDM-TDL instrumented treadmill with pressure sensors.
Description
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
Time Frame
Outcome measures are obtained, at five weeks after intervention.
Title
Gait analysis using the Zebris FDM-TDL instrumented treadmill with pressure sensors.
Description
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
Time Frame
Outcome measures are obtained at three months after intervention
Title
Muscle strength is tested using the Micro Fet Handheld Dynamometer.
Description
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.
Time Frame
Outcome measures are obtained at baseline (pre-intervention)
Title
Muscle strength is tested using the Micro Fet Handheld Dynamometer.
Description
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.
Time Frame
Outcome measures are obtained, at five weeks after intervention.
Title
Muscle strength is tested using the Micro Fet Handheld Dynamometer.
Description
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.
Time Frame
Outcome measures are obtained at three months after intervention
Title
The self-reported health status is measured using the Lysholm Questionaire (LQ)
Description
The participants are asked to complete the eight-item questionnaire, scored on a 0-100 weighted scale
Time Frame
Outcome measures are obtained at baseline (pre-intervention)
Title
The self-reported health status is measured using the Lysholm Questionaire (LQ)
Description
The participants are asked to complete the eight-item questionnaire, scored on a 0-100 weighted scale
Time Frame
Outcome measures are obtained, at five weeks after intervention.
Title
The self-reported health status is measured using the Lysholm Questionaire (LQ)
Description
The participants are asked to complete the eight-item questionnaire, scored on a 0-100 weighted scale
Time Frame
Outcome measures are obtained at three months after intervention

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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: ascending or descending the stairs, prolonged sitting with flexed knee, running or jumping, squatting or kneeling. Exclusion Criteria: Orthopaedic diagnosis other than PFP. Patients with neurological disorders, history of injury or operations within the symptomatic leg, rheumatoid disease, or pregnancy were also excluded from the study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Piotr Michalik
Phone
694979743
Ext
0048
Email
piotrmichalikk@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Tomasz Michalski
Phone
693862340
Ext
0048
Email
michalski@fascia.com.pl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mgdalena Dabrowska-Galas, PhD
Organizational Affiliation
Department of Kinesitherapy and Special Methods, SHS in Katowice, Medical University of Silesia, Katowice, Poland
Official's Role
Study Chair
Facility Information:
Facility Name
Department of Kinesitherapy and Special Methods, SHS in Katowice, Medical University of Silesia, Katowice, Poland
City
Katowice
State/Province
Śląskie
ZIP/Postal Code
40-752
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Magdalena Dąbrowska-Galas, Phd
Phone
515321323
Ext
048
Email
magdalena.j.dabrowska@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
The datasets used and/or analysed during the current study will be available from the corresponding author on reasonable request.

Learn more about this trial

Shock Wave Therapy Versus Neuromuscular Training in Women With Patellofemoral Pain

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