Radial Extracorporeal Shockwave Therapy in Individuals With Iliotibial Band Syndrome
ConditionIliotibial Band Syndrome
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-45
SponsorCairo University
About this trial
The goal of this Clinical Trial Study is to evaluate the clinical effectiveness of Radial Electrocorporeal Shockwave Therapy (rESWT) combined with exercise in individuals with iliotibial band syndrome (ITBS).The main question it aims to answer is : Does the addition of rESWT to standard ITBS exercise program reduce pain intensity and pain pressure threshold while improving lower extremity function and hip muscle strength in Individuals with Iliotibial Band syndrome (ITBS). Participants will be divided into two groups to be compared : The ShamTherapy Group (Control Group) that will receive the standard ITBS exercise program in addition to Sham rESWT, while the experimental group will receive the standard ITBS exercise program in addition to Radial Extracorporeal Shockwave Therapy.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Physically active individuals aged 18 and 45 years
Have a clinical diagnosis of iliotibial band syndrome (ITBS) confirmed by physician within the previous four weeks.
Report lateral knee pain during running or other functional activities
No history of direct trauma
Disqualifiers
History of knee surgery,fracture , meniscal or ligamentous injury within the past year
Any fracture involving the lower extremity within the previous six months
Neurological disorders
Lumbar radiculopathy
Trial design
Design model
Parallel
Treatments tested in this trial
Standard ITBS Exercise Program
Other interventionStandard ITBS Exercise Program : Flexibility and Strengthening Exercises will be delivered three times weekly over a 4-week period
Radial Extracorporeal Shockwave Therapy
DeviceRadial Extracorporeal Shockwave Therapy will be delivered once weekly for 4 weeks only.
Sham Extracorporal Shockwave Therapy
DeviceSham Extracorporal Shockwave therapy will be administered once a week for 4 weeks.
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: Sham rESWT and Standard ITBS Exercise ProgramActive comparator 2 interventions
Group B: rESWT combined with exercise programExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Numerical Pain Rating Scale Score (NPRS)
To assess lateral knee pain intensity at rest and during activity Scores range from 0 (no pain) to 10 (worst pain)
Time frame
baseline , immediately after the 4-week intervention period ( post intervention ) ,4 weeks after the intervention cessation as follow-up.Secondary outcomes
1
Lower extremity Functional Scale (LEFS)
to assess the functional status of lower extremities. It consists of 20 items, each item is scored according to its difficulty : from 0 (extreme difficulty) to 4 (no difficulty),with a maximum score of 80 ( full function).
Time frame
baseline , immediately after the 4-week intervention period ( post intervention ) ,4 weeks after the intervention cessation as follow-up.2
Hip muscle strength dynamometer testing
Hip ABD , ADD , IR and ER strength will be measured. Each strength will be measured twice using a hand held dynamometer . The mean value of the two values will be calculated.
Time frame
baseline , immediately after the 4-week intervention period ( post intervention ) ,4 weeks after the intervention cessation as follow-up.3
Pain Pressure Threshold algometry testing (PPT)
PPT is measured three times using algometry that applies a gradually increasing pressure over the lateral femoral condyle\\distal ITB region until PPT is reached. The average of the 3 measurements will be calculated.
Time frame
baseline , immediately after the 4-week intervention period ( post intervention ) ,4 weeks after the intervention cessation as follow-up.Sponsors and contacts
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Source ClinicalTrials.gov