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IRCT20160221026674N9 IRCT 2026-01-24 Shiraz University of Medical Sciences Studying the effect of needling muscles attached to the iliotibial band on clinical symptoms of patients with iliotibial band syndrome Comparing of the effect of gluteus maximus, gluteus medius, and tensor fascia lata muscle needling versus sham needling on the findings of clinical tests and symptoms in patients with iliotibial band syndrome: A randomized clinical trial 2026-01-31 anticipated 30 Recruiting https://irct.ir/trial/87924 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The randomization method in this study will be the permutation block method, which will be generated using the PASS 2021 software. A desired random list, consisting of 5 blocks of 6, will be generated. The project manager will carry out this process. The allocation of samples will be done in a 1:1 ratio. In order to conceal the allocation, opaque and sealed envelopes will be used, which will be opened by the therapist after the evaluation process is completed by the evaluator, Blinding description: The assessor and the therapist are two separate individuals, and the assessor is blind to the intervention groups. Patients are unaware of the intervention when receiving the sham needling technique. 3 Iliotibial band syndrome. Intervention 1: Intervention group:10 sessions of Burst TENS with a pulse frequency of 100 Hz and a burst frequency of 10 Hz, a pulse width of 200 microseconds, for 20 minutes10 sessions of continuous ultrasound (duty cycle 100%), with a frequency of 3 MHz, an intensity of 1 W/cm2, and a duration of 5 minutes10 sessions of hot packs for 20 minutes10 sessions of stretching exercises for the tensor fascia lata, gluteus maximus, and gluteus medius muscles in four sets of 30 seconds5 sessions (every other day) of static dry needling in the motor points of the tensor fascia lata, gluteus maximus, and gluteus medius muscles for 20 minutes. Intervention 2: Control group: 10 sessions of Burst TENS with a pulse frequency of 100 Hz and a burst frequency of 10 Hz, a pulse width of 200 microseconds, for 20 minutes10 sessions of continuous ultrasound (duty cycle 100%), with a frequency of 3 MHz, an intensity of 1 W/cm2, and a duration of 5 minutes10 sessions of hot packs for 20 minutes10 sessions of stretching exercises for the tensor fascia lata, gluteus maximus, and gluteus medius muscles in four sets of 30 seconds5 sessions (every other day) of sham dry needling in the the tensor fascia lata, gluteus maximus, and gluteus medius muscles with guide pressure and without entering the patient's body. Yes - There is a plan to make this available What will be shared: Data collection form including primary and secondary outcomes, informed consent form, and SPSS file When: After the publication of the study results To whom: Researchers working in academic and scientific institutions Conditions: Recording information in scientific databases Where to obtain: Correspondence with the project manager by email. mohamadm@sums.ac.ir How to obtain: Maximum one month after sending the request by email Comments:
public Marzieh Mohamadi
School of Rehabilitation Sciences, after Amir-al-Momenin Burn Accident Hospital, Shahid Doran Campus, Sadra Town Road
Shiraz Iran (Islamic Republic of) 7198754361 +98 71 3212 2600 mohamadm@sums.ac.ir Shiraz University of Medical Sciences scientific Marzieh Mohamadi
School of Rehabilitation Sciences, after Amir-al-Momenin Burn Accident Hospital, Shahid Doran Campus, Sadra Town Road
Shiraz Iran (Islamic Republic of) 7198754361 +98 71 3212 2600 mohamadm@sums.ac.ir Shiraz University of Medical Sciences Iran (Islamic Republic of) Patients with iliotibial band syndrome in the subacute or chronic phase of the disease Aged between 18 and 45 years Presence of pain and tenderness (4 or higher on the numerical pain scale) at the site of attachment of the band to the lateral epicondyle of the femur Activity level 5 to 10 according to the Tegner scale 18 years 45 years Both Body mass index greater than 30 Any orthopedic or neurological disorder A history of knee injury or history of knee physiotherapy in the previous 12 months Limited range of motion Fibromyalgia or chronic pain syndrome Systemic inflammatory diseases Corticosteroid injections or use of anti-inflammatory drugs in the past month Phobia of needles Use of anticoagulant drugs Uncontrolled diabetes Any musculoskeletal disorder in the lower extremities except iliotibial band syndrome M76.3 Iliotibial band syndrome Rehabilitation Rehabilitation Intervention group:10 sessions of Burst TENS with a pulse frequency of 100 Hz and a burst frequency of 10 Hz, a pulse width of 200 microseconds, for 20 minutes10 sessions of continuous ultrasound (duty cycle 100%), with a frequency of 3 MHz, an intensity of 1 W/cm2, and a duration of 5 minutes10 sessions of hot packs for 20 minutes10 sessions of stretching exercises for the tensor fascia lata, gluteus maximus, and gluteus medius muscles in four sets of 30 seconds5 sessions (every other day) of static dry needling in the motor points of the tensor fascia lata, gluteus maximus, and gluteus medius muscles for 20 minutes Control group: 10 sessions of Burst TENS with a pulse frequency of 100 Hz and a burst frequency of 10 Hz, a pulse width of 200 microseconds, for 20 minutes10 sessions of continuous ultrasound (duty cycle 100%), with a frequency of 3 MHz, an intensity of 1 W/cm2, and a duration of 5 minutes10 sessions of hot packs for 20 minutes10 sessions of stretching exercises for the tensor fascia lata, gluteus maximus, and gluteus medius muscles in four sets of 30 seconds5 sessions (every other day) of sham dry needling in the the tensor fascia lata, gluteus maximus, and gluteus medius muscles with guide pressure and without entering the patient's body Pain intensity. Timepoint: Before, one day after and two weeks after treatment. Method of measurement: Visual Analogue Scale. Lower Limb Function. Timepoint: Before, one day after and two weeks after treatment. Method of measurement: Lower extremity functional scale. The findings from the Rene, Noble, Uber, and modified Thomas diagnostic tests. Timepoint: Before, one day after and two weeks after treatment. Method of measurement: Positive or negative test result. Personal Approved 2025-12-03 Ethics committee of Shiraz University of Medical Sciences Ethics committee, Research and Technology Vice-Chancellor, 7th floor, central building of Shiraz University of Medical Sciences, Zand Street Shiraz Fars Iran (Islamic Republic of)