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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06410781
Other study ID # P.T.REC/012/004959
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date May 20, 2024
Est. completion date November 20, 2024

Study information

Verified date May 2024
Source Cairo University
Contact Mohamed Elmogy, master
Phone 0 103 252 8827
Email mohamedmedomogy@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 60
Est. completion date November 20, 2024
Est. primary completion date November 20, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 55 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Cairo University

Outcome

Type Measure Description Time frame Safety issue
Primary iliotibial band thickness ultrasonography device will be used to assess iliotibial band thickness up to six weeks
Secondary 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
Secondary pressure pain threshold pressure algometer will be used to assess pressure pain threshold up to six weeks
Secondary 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
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