Shock Wave Therapy Versus Neuromuscular Training in Women With Patellofemoral Pain

NCT03324204 | Unknown

• 1 other identifier: kolanostudentki
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Conditions

Patellofemoral Pain Syndrome; Knee Pain Chronic

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (9)

• Gait analysis using the Zebris FDM-TDL instrumented treadmill with pressure sensors.

  Outcome measures are obtained at baseline (pre-intervention)

• Gait analysis using the Zebris FDM-TDL instrumented treadmill with pressure sensors.

  Outcome measures are obtained, at five weeks after intervention.

• Gait analysis using the Zebris FDM-TDL instrumented treadmill with pressure sensors.

  Outcome measures are obtained at three months after intervention

• Muscle strength is tested using the Micro Fet Handheld Dynamometer.

  Outcome measures are obtained at baseline (pre-intervention)

• Muscle strength is tested using the Micro Fet Handheld Dynamometer.

  Outcome measures are obtained, at five weeks after intervention.

Study Arms (2)

Neuromuscular Training

EXPERIMENTAL

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

Shock Wave Therapy

ACTIVE COMPARATOR

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)

Interventions

Neuromuscular Training OTHER

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

Neuromuscular Training

Extracorporeal Shock Wave Therapy (ESWT) OTHER

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

Shock Wave Therapy

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medical University of Silesia: lead

Study Sites (1)

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

Katowice, Silesian Voivodeship, 40-752, Poland

RECRUITING

MeSH Terms

Conditions

Patellofemoral Pain Syndrome

Interventions

Extracorporeal Shockwave Therapy

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Ultrasonic Therapy; Diathermy; Hyperthermia, Induced; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Mgdalena Dabrowska-Galas, PhD

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

  STUDY CHAIR

Central Study Contacts

Piotr Michalik

CONTACT

694979743; piotrmichalikk@gmail.com

Tomasz Michalski

CONTACT

693862340; michalski@fascia.com.pl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 18, 2017
• First Posted: October 27, 2017
• Study Start: August 1, 2014
• Primary Completion: June 1, 2018
• Study Completion: January 1, 2019
• Last Updated: October 27, 2017

Record last verified: 2017-10

Locations

PL (1)