Iliotibial Band SyndromeITBNCT06410781
Effect of Radial Extracorporeal Shockwave Therapy on Ultrasonography Changes in Patients With Iliotibial Band Syndrome
A study testing Radial Extracorporeal Shockwave and traditional therapy in people with Iliotibial Band Syndrome, run by Cairo University.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Iliotibial Band Syndrome
- What is being tested?
- Radial Extracorporeal Shockwave and traditional therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 20 May 2024to 20 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Sixty patients suffer from ITBS.
- The age of patients ranges from (18-55) years.
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
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
Read the 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.
- Conditions
- Iliotibial Band Syndrome
- Being tested
- Radial Extracorporeal Shockwave, traditional therapy
- Keywords
- iliotibial band syndrome, Radial Extracorporeal Shockwave, ultrasonography changes
- 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.
Radial Extracorporeal ShockwaveOther
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.
traditional therapyOther
the patients will receive traditional therapy in the form of stretching exercise, manual therapy and ultrasound on iliotibial band.
| Study group | Role | What they receive |
|---|---|---|
| Radial Extracorporeal Shockwave | Experimental | thirty patients with iliotibial band syndrome will receive Radial Extracorporeal Shockwave and traditional therapy three times a week for six weeks. Receives: Other: Radial Extracorporeal Shockwave; Other: traditional therapy |
| traditional therapy | Active comparator | Thirty patients with iliotibial band syndrome will receive traditional therapy three times a week for six weeks. Receives: Other: traditional therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
iliotibial band thickness
ultrasonography device will be used to assess iliotibial band thickness
Measured: up to six weeks
Secondary outcomes (3)
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.
Measured: up to six weeks
pressure pain threshold
pressure algometer will be used to assess pressure pain threshold
Measured: 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
Measured: up to six weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2024
- Study start20 May 2024 (estimated)
- Primary completion20 Nov 2024 (estimated)
- Study completion20 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Model description
- Radial Extracorporeal Shockwave Therapy and traditional therapy
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nabil Mahmoud Ismail Abdel-Aal, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06410781
- Sponsor's protocol ID
- P.T.REC/012/004959
- Acronym
- ITB
- Status last verified
- May 2024
- First submitted
- 8 May 2024
- Last updated
- 13 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Radial Extracorporeal Shockwave Therapy on Ultrasonography Changes in Patients With Iliotibial Band Syndrome
- ClinicalTrials.gov ID
- NCT06410781
- Acronym / sponsor ID
- ITB / P.T.REC/012/004959
- Conditions
- Iliotibial Band Syndrome
- Keywords
- iliotibial band syndrome, Radial Extracorporeal Shockwave, ultrasonography changes
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 20 May 2024 (estimated)
- Primary completion
- 20 Nov 2024 (estimated)
- Study completion
- 20 Nov 2024 (estimated)
- First posted
- 13 May 2024 (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.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Radial Extracorporeal Shockwave Therapy and traditional therapy
| Arm | Type | Receives |
|---|---|---|
| Radial Extracorporeal Shockwave | Experimental | Other: Radial Extracorporeal Shockwave, Other: traditional therapythirty patients with iliotibial band syndrome will receive Radial Extracorporeal Shockwave and traditional therapy three times a week for six weeks. |
| traditional therapy | Active comparator | Other: traditional therapyThirty patients with iliotibial band syndrome will receive traditional therapy three times a week for six weeks. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Sixty patients suffer from ITBS.
- The age of patients ranges from (18-55) years.
Key exclusion criteria (7 listed)
- 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.
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 |
|---|---|---|
| Radial Extracorporeal ShockwaveTreatment 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 | Radial Extracorporeal Shockwave |
| traditional therapythe patients will receive traditional therapy in the form of stretching exercise, manual therapy and ultrasound on iliotibial band. | Other | Radial Extracorporeal Shockwave, traditional therapy |
Primary outcome
iliotibial band thickness
Time frame: up to six weeks
ultrasonography device will be used to assess iliotibial band thickness
3 secondary outcomes
pain intensity
Time frame: up to six weeks
pressure pain threshold
Time frame: up to six weeks
lower extremity function
Time frame: up to six weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2024.
Related trials for Iliotibial Band Syndrome
Recruiting
Progressive Resistance Training for Adults With External Snapping Hip
External Snapping Hip, Coxa Saltans External
Not yet recruiting
Exercise Program for ITB Syndrome
Iliotibial Band Syndrome
Recruiting
Radial Extracorporeal Shockwave Therapy in Individuals With Iliotibial Band Syndrome
Iliotibial Band Syndrome
Recruiting
Evaluation of TENEX for Greater Trochanteric Pain Syndrome (GTPS)
Greater Trochanteric Pain Syndrome
Recruiting
Autogenic Inhibition Versus Reciprocal Inhibition Muscle Energy Techniques in Iliotibial Band Syndrome
Iliotibial Band Syndrome
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. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing Radial Extracorporeal Shockwave and traditional therapy in people with Iliotibial Band Syndrome, run by Cairo University.
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 2 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 13 May 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mohamed Elmogy, master (0 103 252 8827, mohamedmedomogy@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
iliotibial band thickness (time frame: up to six weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 May 2024.