Shock Wave Therapy Versus Neuromuscular Training in Women With Patellofemoral Pain

NCT ID: NCT03324204

Last Updated: 2017-10-27

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-08-01
• Study Completion Date: 2019-01-01

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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

Group Type: EXPERIMENTAL

Neuromuscular Training

Intervention Type: 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

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.

Group Type: ACTIVE_COMPARATOR

Extracorporeal Shock Wave Therapy (ESWT)

Intervention Type: 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

Interventions

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

Intervention Type: 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

Intervention Type: OTHER

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:

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 30 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Medical University of Silesia

OTHER

Sponsor Role: lead

Responsible Party

Piotr Michalik

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mgdalena Dabrowska-Galas, PhD

Role: STUDY_CHAIR

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

Locations

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

Katowice, Silesian Voivodeship, Poland

Site Status: RECRUITING

Countries

Poland

Central Contacts

Piotr Michalik

Role: CONTACT

Phone: 694979743

Email: piotrmichalikk@gmail.com

Tomasz Michalski

Role: CONTACT

Phone: 693862340

Email: michalski@fascia.com.pl

Facility Contacts

Magdalena Dąbrowska-Galas, Phd

Role: primary

Other Identifiers

kolanostudentki

Identifier Type: -

Identifier Source: org_study_id