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

NCT ID: NCT06410781

Last Updated: 2024-05-13

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-20
• Study Completion Date: 2024-11-20

Brief 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

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Radial Extracorporeal Shockwave

thirty patients with iliotibial band syndrome will receive Radial Extracorporeal Shockwave and traditional therapy three times a week for six weeks.

Group Type: EXPERIMENTAL

Radial Extracorporeal Shockwave

Intervention Type: OTHER

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 therapy

Intervention Type: OTHER

the patients will receive traditional therapy in the form of stretching exercise, manual therapy and ultrasound on iliotibial band.

traditional therapy

Thirty patients with iliotibial band syndrome will receive traditional therapy three times a week for six weeks.

Group Type: ACTIVE_COMPARATOR

traditional therapy

Intervention Type: OTHER

the patients will receive traditional therapy in the form of stretching exercise, manual therapy and ultrasound on iliotibial band.

Interventions

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.

Intervention Type: OTHER

traditional therapy

the patients will receive traditional therapy in the form of stretching exercise, manual therapy and ultrasound on iliotibial band.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Nabil Mahmoud Ismail Abdel-Aal

principle investigator nabil mahmoud ismail abdel-aal

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Mohamed Elmogy, master

Role: CONTACT

mohamedmedomogy@gmail.com

0 103 252 8827

Other Identifiers

P.T.REC/012/004959

Identifier Type: -

Identifier Source: org_study_id