Shock Wave Therapy Versus Neuromuscular Training in Women With Patellofemoral Pain

Study Overview
=================
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

Official Title
-----------------
Shock Wave Therapy Versus Neuromuscular Training in Women With Patellofemoral Pain

Conditions
-----------------
Patellofemoral Pain Syndrome, Knee Pain Chronic

Intervention / Treatment
-----------------
* Other: Neuromuscular Training
* Other: Extracorporeal Shock Wave Therapy (ESWT)


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 30 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Neuromuscular Training<br>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<br>* 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<br>|
| Active Comparator: Shock Wave Therapy<br>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)<br>* 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<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | Outcome measures are obtained at baseline (pre-intervention) | 
| 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) | Outcome measures are obtained, at five weeks after intervention. | 
| 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) | Outcome measures are obtained at three months after intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Outcome measures are obtained at baseline (pre-intervention) | 
| 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 | Outcome measures are obtained, at five weeks after intervention. | 
| 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 | Outcome measures are obtained at three months after intervention | 
| 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. | Outcome measures are obtained at baseline (pre-intervention) | 
| 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. | Outcome measures are obtained, at five weeks after intervention. | 
| 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. | Outcome measures are obtained at three months after intervention | 
| 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 | Outcome measures are obtained at baseline (pre-intervention) | 
| 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 | Outcome measures are obtained, at five weeks after intervention. | 
| 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 | Outcome measures are obtained at three months after intervention |