Effect of Radial Extracorporeal Shockwave Therapy on Ultrasonography Changes in Patients With Iliotibial Band Syndrome (ITB)

this study will be conducted to investigate the effects of radial extracorporeal shockwave therapy on ultrasonography changes, pain intensity, pain pressure threshold and lower limb function in patient with iliotibial band syndrome

Study Overview

• Status: Not yet recruiting
• Conditions: Iliotibial Band Syndrome
• Intervention / Treatment: Other: Radial Extracorporeal Shockwave; Other: traditional therapy

Detailed Description

Iliotibial Band Syndrome is an overuse injury that affect the lateral aspect of the knee. It is common in endurance sport activities such as running and cycling. It is the most common running injury of the lateral knee. ITBS is a non-traumatic overuse injury caused by friction/rubbing of the distal portion of the iliotibial band (ITB) over the lateral femoral epicondyle with repeated flexion and extension of the knee. Females are twice as likely to sustain ITBS compared to male due to sex differences in frontal and transverse plane hip and knee joint angles.An alternative treatment strategy of ITBS is radial extracorporeal shockwave therapy (RESWT). It is considered safe as it results in minor adverse effects including worsening of symptoms over a short period, reversible local swelling, redness and hematoma. RESWT has also shown to be effective in the treatment of several chronic musculoskeletal pain conditions such as lateral epicondylitis, Achilles tendinopathy, plantar fasciitis, patellar tendinopathy, calcific tendinitis of the shoulder and chronic proximal hamstring tendinopathy. sixty patients with iliotibial band syndrome will be assigned randomly to two groups; the first one will receive radial extracorporeal shockwave and traditional therapy, the second one will receive traditional therapy alone.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mohamed Elmogy, master; Phone Number: 0 103 252 8827; Email: mohamedmedomogy@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Sixty patients suffer from ITBS.
• The age of patients ranges from (18-55) years.

Exclusion Criteria:

• Signs or symptoms of other pathologies of the knee.
• Previous treatment for ITBS in the last 6 months.
• Use of NSAID's or analgesics later than two weeks before baseline.
• Previous surgery on the affected knee.
• Pregnancy.
• Rheumatic disease.
• Previous shockwave treatment

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: Radial Extracorporeal Shockwave; thirty patients with iliotibial band syndrome will receive Radial Extracorporeal Shockwave and traditional therapy three times a week for six weeks.	Other: Radial Extracorporeal Shockwave; Treatment procedure will be initiated by palpation to locate the painful area around the lateral femoral condyle and the lateral side of the thigh. The therapist uses the principle of clinical focusing where the patient guides the therapist to the most painful area. The area will be treated in a circumferential pattern, starting at the point of maximum pain. At each of the session a total of 4600 pulses will be applied. RESWT will start with 500 pulses at (2 Bar) with the frequency of 15 Hz to the lateral femoral condyle to adjust to treatment.An additional 2000 pulses will be applied at (2- 4 Bar), 15 Hz, depending on pain tolerance. in addition,stretching exercise, manual therapy, and ultrasound on the iliotibial band.; Other: traditional therapy; the patients will receive traditional therapy in the form of stretching exercise, manual therapy and ultrasound on iliotibial band.
Active Comparator: traditional therapy; Thirty patients with iliotibial band syndrome will receive traditional therapy three times a week for six weeks.	Other: traditional therapy; the patients will receive traditional therapy in the form of stretching exercise, manual therapy and ultrasound on iliotibial band.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
iliotibial band thickness	ultrasonography device will be used to assess iliotibial band thickness	up to six weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
pain intensity	The visual analog scale (VAS) will be used to assess pain intensity. Scores are based on self-reported measures of symptoms that are recorded with a single handwritten mark placed at one point along the length of a 100mm line that represents a continuum between the two ends of the scale "no pain" on the left end of the scale and the "worst pain" on the right end of the scale.	up to six weeks
pressure pain threshold	pressure algometer will be used to assess pressure pain threshold	up to six weeks
lower extremity function	The lower extremity functional scale is a well-known and validated patient-rated outcome measure that can be used to measure lower extremity function. The score consists of 20 questions, which are subdivided into 4 groups. These groups consist of activities with increasing physical demands. Questions on activity vary from walking between rooms to running on uneven ground. Each item is scored on a scale of 0 to 4, with a higher score indicating better function. The total score ranges from 0 to 80, with higher scores indicating better lower limb function	up to six weeks

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Estimated): May 20, 2024
• Primary Completion (Estimated): November 20, 2024
• Study Completion (Estimated): November 20, 2024

Study Registration Dates

• First Submitted: May 8, 2024
• First Submitted That Met QC Criteria: May 8, 2024
• First Posted (Actual): May 13, 2024

Study Record Updates

• Last Update Posted (Actual): May 13, 2024
• Last Update Submitted That Met QC Criteria: May 8, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: iliotibial band syndrome; Radial Extracorporeal Shockwave; ultrasonography changes
• Additional Relevant MeSH Terms: Pathologic Processes; Wounds and Injuries; Leg Injuries; Disease; Cumulative Trauma Disorders; Sprains and Strains; Knee Injuries; Syndrome; Iliotibial Band Syndrome
• Other Study ID Numbers: P.T.REC/012/004959

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No