Shock Wave Therapy Versus Neuromuscular Training in Women With Patellofemoral Pain

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: Unknown
• Conditions: Patellofemoral Pain Syndrome; Knee Pain Chronic
• Intervention / Treatment: Other: Neuromuscular Training; Other: Extracorporeal Shock Wave Therapy (ESWT)

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

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

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

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

Collaborators and Investigators

• Sponsor: Medical University of Silesia
• Investigators: Study Chair: Mgdalena Dabrowska-Galas, PhD, Department of Kinesitherapy and Special Methods, SHS in Katowice, Medical University of Silesia, Katowice, Poland

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2014
• Primary Completion (Anticipated): June 1, 2018
• Study Completion (Anticipated): January 1, 2019

Study Registration Dates

• First Submitted: July 18, 2017
• First Submitted That Met QC Criteria: October 24, 2017
• First Posted (Actual): October 27, 2017

Study Record Updates

• Last Update Posted (Actual): October 27, 2017
• Last Update Submitted That Met QC Criteria: October 24, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Patellofemoral Pain Syndrome
• Other Study ID 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