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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.
The Iliotibial Band Syndrome is a frequently occurring overuse condition among runners and active individuals that often leads to persistent lateral knee pain and reduced function. Although exercise, particularly hip abductor strengthening, is considered effective, the optimal rehabilitation approach remains unclear. Recent evidence suggests that combining Radial Extracorporeal Shockwave Therapy with exercise may improve pain and function more than exercise alone.Therefore, evaluating whether the combination of rESWT and exercise is more effective than exercise alone is clinically relevant.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sham rESWT and Standard ITBS Exercise Program | Active Comparator | This group will receive Sham rESWT and standard ITBS Exercise Program that will include ITB stretching and strengthening exercises mainly targeting hip abductors, hip external rotators and knee extensors. |
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| rESWT combined with exercise program | Experimental | The experimental group will receive the same standard exercise program in addition to rESWT on the distal portion of the ITB and the region of lateral femoral condyle. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard ITBS Exercise Program | Other | Standard ITBS Exercise Program : Flexibility and Strengthening Exercises will be delivered three times weekly over a 4-week period |
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| Measure | Description | Time Frame |
|---|---|---|
| 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) | baseline , immediately after the 4-week intervention period ( post intervention ) ,4 weeks after the intervention cessation as follow-up. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | baseline , immediately after the 4-week intervention period ( post intervention ) ,4 weeks after the intervention cessation as follow-up. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ahmad El Melhat, PhD | Contact | +20 11 12595022 | ahmed.elmelhat@cu.edu.lb |
| Name | Affiliation | Role |
|---|---|---|
| Ahmed El Melhat, PhD | Cairo University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cairo University Hospitals | Recruiting | Giza | Giza Governorate | 2356 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26406193 | Background | Weckstrom K, Soderstrom J. Radial extracorporeal shockwave therapy compared with manual therapy in runners with iliotibial band syndrome. J Back Musculoskelet Rehabil. 2016;29(1):161-70. doi: 10.3233/BMR-150612. | |
| 32448384 | Background | McKay J, Maffulli N, Aicale R, Taunton J. Iliotibial band syndrome rehabilitation in female runners: a pilot randomized study. J Orthop Surg Res. 2020 May 24;15(1):188. doi: 10.1186/s13018-020-01713-7. |
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| ID | Term |
|---|---|
| D058745 | Iliotibial Band Syndrome |
| ID | Term |
|---|---|
| D007718 | Knee Injuries |
| D007869 | Leg Injuries |
| D014947 | Wounds and Injuries |
| D012090 | Cumulative Trauma Disorders |
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| Radial Extracorporeal Shockwave Therapy | Device | Radial Extracorporeal Shockwave Therapy will be delivered once weekly for 4 weeks only. |
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| Sham Extracorporal Shockwave Therapy | Device | Sham Extracorporal Shockwave therapy will be administered once a week for 4 weeks. |
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| 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. | baseline , immediately after the 4-week intervention period ( post intervention ) ,4 weeks after the intervention cessation as follow-up. |
| 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. | baseline , immediately after the 4-week intervention period ( post intervention ) ,4 weeks after the intervention cessation as follow-up. |
| 34375405 | Background | Geisler PR. Current Clinical Concepts: Synthesizing the Available Evidence for Improved Clinical Outcomes in Iliotibial Band Impingement Syndrome. J Athl Train. 2021 Aug 1;56(8):805-815. doi: 10.4085/1062-6050-548-19. Epub 2020 Dec 22. |
| D013180 |
| Sprains and Strains |