Clinical trial NCT03324204: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Patellofemoral Pain Syndrome
Knee Pain Chronic
Lead sponsor: Medical University of Silesia
Sponsor class: OTHER
First posted: 2017-10-27
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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.

Primary outcomes:
measure: Visual Analog Scale is used to assess the subjective Pain.
timeFrame: Outcome measures are obtained at baseline (pre-intervention)
measure: Visual Analog Scale is used to assess the subjective Pain.
timeFrame: Outcome measures are obtained, at five weeks after intervention.
measure: Visual Analog Scale is used to assess the subjective Pain.
timeFrame: Outcome measures are obtained at three months after intervention
Secondary outcomes:
measure: Gait analysis using the Zebris FDM-TDL instrumented treadmill with pressure sensors.
timeFrame: Outcome measures are obtained at baseline (pre-intervention)
measure: Gait analysis using the Zebris FDM-TDL instrumented treadmill with pressure sensors.
timeFrame: Outcome measures are obtained, at five weeks after intervention.
measure: Gait analysis using the Zebris FDM-TDL instrumented treadmill with pressure sensors.
timeFrame: Outcome measures are obtained at three months after intervention
measure: Muscle strength is tested using the Micro Fet Handheld Dynamometer.
timeFrame: Outcome measures are obtained at baseline (pre-intervention)
measure: Muscle strength is tested using the Micro Fet Handheld Dynamometer.
timeFrame: Outcome measures are obtained, at five weeks after intervention.
measure: Muscle strength is tested using the Micro Fet Handheld Dynamometer.
timeFrame: Outcome measures are obtained at three months after intervention
measure: The self-reported health status is measured using the Lysholm Questionaire (LQ)
timeFrame: Outcome measures are obtained at baseline (pre-intervention)
measure: The self-reported health status is measured using the Lysholm Questionaire (LQ)
timeFrame: Outcome measures are obtained, at five weeks after intervention.
measure: The self-reported health status is measured using the Lysholm Questionaire (LQ)
timeFrame: Outcome measures are obtained at three months after intervention
Other outcomes:
Locations:
city: Katowice
country: Poland
facility: Department of Kinesitherapy and Special Methods, SHS in Katowice, Medical University of Silesia, Katowice, Poland
state: Śląskie
Study officials:
affiliation: Department of Kinesitherapy and Special Methods, SHS in Katowice, Medical University of Silesia, Katowice, Poland
name: Mgdalena Dabrowska-Galas, PhD
role: STUDY_CHAIR
References: