Iliotibial Band SyndromeNCT07668011
Radial Extracorporeal Shockwave Therapy in Individuals With Iliotibial Band Syndrome
A study testing Standard ITBS Exercise Program and Radial Extracorporeal Shockwave Therapy in people with Iliotibial Band Syndrome, run by Cairo University at 1 site in Egypt.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Iliotibial Band Syndrome
- What is being tested?
- Standard ITBS Exercise Program and Radial Extracorporeal Shockwave Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Jun 2026to 30 Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
- Have a positive Noble compression or/and Ober test.
Who cannot join
- 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
- Systemic inflammatory disease
- Any medical condition affecting gat or lower extremity function.
Show all 9Show fewer
- Have received corticosteroid injection, shockwave therapy, or physical therapy treatment for ITBS within the previous six months
- Use of NDAID's or analgesics later than 2 weeks
- Individuals with contraindications to ESWT, including pregnancy, bleeding disorders, or use of anticoagulant medication.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Cairo University Hospitals
Giza, Giza Governorate, 2356
About this study
Official title: Effectiveness of Radial Extracorporeal Shockwave Therapy in Individuals With Iliotibial Band Syndrome
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.
Read the detailed description
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.
- Conditions
- Iliotibial Band Syndrome
- Being tested
- Standard ITBS Exercise Program, Radial Extracorporeal Shockwave Therapy, Sham Extracorporal Shockwave Therapy
- Keywords
- Iliotibial Band Syndrome, ITBS, ESWT, rESWT, Extracorporeal Shockwave Therapy, Radial Extracorporeal Shockwave Therapy
- Medical subject headings
- Iliotibial Band Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard ITBS Exercise ProgramOther
Standard ITBS Exercise Program : Flexibility and Strengthening Exercises will be delivered three times weekly over a 4-week period
Radial Extracorporeal Shockwave TherapyDevice
Radial Extracorporeal Shockwave Therapy will be delivered once weekly for 4 weeks only.
Sham Extracorporal Shockwave TherapyDevice
Sham Extracorporal Shockwave therapy will be administered once a week for 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Standard ITBS Exercise Program; Device: Sham Extracorporal Shockwave Therapy |
| 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. Receives: Other: Standard ITBS Exercise Program; Device: Radial Extracorporeal Shockwave Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: baseline , immediately after the 4-week intervention period ( post intervention ) ,4 weeks after the intervention cessation as follow-up.
Secondary outcomes (3)
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).
Measured: baseline , immediately after the 4-week intervention period ( post intervention ) ,4 weeks after the intervention cessation as follow-up.
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.
Measured: 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.
Measured: baseline , immediately after the 4-week intervention period ( post intervention ) ,4 weeks after the intervention cessation as follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2026
- Study start10 Jun 2026 (estimated)
- Primary completion10 Aug 2026 (estimated)
- Study completion30 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Iliotibial Band SyndromeStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed ElMelhat, Cairo University
- Investigators
- Ahmed El Melhat, PhD, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07668011
- Sponsor's protocol ID
- rESWT and exercises in ITBS
- Status last verified
- Jun 2026
- First submitted
- 19 Jun 2026
- Last updated
- 25 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 26406193McKay 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.
PubMed 32448384Geisler 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.
PubMed 34375405
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Radial Extracorporeal Shockwave Therapy in Individuals With Iliotibial Band Syndrome
- ClinicalTrials.gov ID
- NCT07668011
- Acronym / sponsor ID
- rESWT and exercises in ITBS
- Conditions
- Iliotibial Band Syndrome
- Keywords
- Iliotibial Band Syndrome, ITBS, ESWT, rESWT, Extracorporeal Shockwave Therapy, Radial Extracorporeal Shockwave Therapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 10 Jun 2026 (estimated)
- Primary completion
- 10 Aug 2026 (estimated)
- Study completion
- 30 Aug 2026 (estimated)
- First posted
- 25 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sham rESWT and Standard ITBS Exercise Program | Active comparator | Other: Standard ITBS Exercise Program, Device: Sham Extracorporal Shockwave TherapyThis 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. |
| rESWT combined with exercise program | Experimental | Other: Standard ITBS Exercise Program, Device: Radial Extracorporeal Shockwave TherapyThe 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
- Have a positive Noble compression or/and Ober test.
Key exclusion criteria (9 listed)
- 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
- Systemic inflammatory disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard ITBS Exercise ProgramStandard ITBS Exercise Program : Flexibility and Strengthening Exercises will be delivered three times weekly over a 4-week period | Other | Sham rESWT and Standard ITBS Exercise Program, rESWT combined with exercise program |
| Radial Extracorporeal Shockwave TherapyRadial Extracorporeal Shockwave Therapy will be delivered once weekly for 4 weeks only. | Device | rESWT combined with exercise program |
| Sham Extracorporal Shockwave TherapySham Extracorporal Shockwave therapy will be administered once a week for 4 weeks. | Device | Sham rESWT and Standard ITBS Exercise Program |
Primary outcome
Numerical Pain Rating Scale Score (NPRS)
Time frame: baseline , immediately after the 4-week intervention period ( post intervention ) ,4 weeks after the intervention cessation as follow-up.
To assess lateral knee pain intensity at rest and during activity Scores range from 0 (no pain) to 10 (worst pain)
3 secondary outcomes
Lower extremity Functional Scale (LEFS)
Time frame: baseline , immediately after the 4-week intervention period ( post intervention ) ,4 weeks after the intervention cessation as follow-up.
Hip muscle strength dynamometer testing
Time frame: 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)
Time frame: baseline , immediately after the 4-week intervention period ( post intervention ) ,4 weeks after the intervention cessation as follow-up.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2026.
- Background: PubMed 26406193Weckstrom 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.
- Background: PubMed 32448384McKay 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.
- Background: PubMed 34375405Geisler 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ahmed El Melhat, PhD principal investigator
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard ITBS Exercise Program and Radial Extracorporeal Shockwave Therapy in people with Iliotibial Band Syndrome, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ahmad El Melhat, PhD (+20 11 12595022, ahmed.elmelhat@cu.edu.lb), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numerical Pain Rating Scale Score (NPRS) (time frame: baseline , immediately after the 4-week intervention period ( post intervention ) ,4 weeks after the intervention cessation as follow-up.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07668011, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2026.