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IRCT20220127053838N1 IRCT 2022-02-11 Radial extracorporeal shock wave therapy addition on routine physiotherapy treatment on the balance& pain & disability of patients with chronic non-specific low back pain caused by gluteal muscle trigger points The effect of radial extracorporeal shock wave therapy addition on routine physiotherapy treatment on the balance& pain & disability of patients with chronic non-specific low back pain caused by gluteal muscle trigger points 2022-04-08 anticipated 34 Complete https://irct.ir/trial/61597 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Single, Purpose: Treatment, Randomization description: In this study, we use the randomized permutation block method for random assignment. The procedure will be such that two and six blocks with a combination of A (intervention group) and B (control group) will be the criteria for operation.Depending on the different combinations, each of the blocks is assigned a number as follows: Block 1: BBABAA Block 2: BA Block 3: BBAABA Block 4: BABBAA Block 5: AB Block 6: AB Block 7: BA Block 8: AB Block 9: BAAABB Using a table of random numbers, considering the numbers 1 to 9 and deleting the number zero, the blocks are selected respectively and the method of assigning patients to one of the groups A and B is done according to the selected blocks. After preparing a randomization list for each patient, they will have a number in the order of enrollment (from 1 to 34) A sealed envelope is provided with A or B written inside the envelope based on the compiled list. The researcher who does not know the main list, after registering the person entered to study and check the number of the person, opens the relevant envelope and realizes the type of intervention based on the contents of the envelope. In this way, the researcher realizes the type of intervention only after the patient enters the study and determines his eligibility, by opening the envelope, and finally we will have two balanced groups, Blinding description: The person doing the assessment is different from the person doing the intervention. N/A Chronic nonspecific low back pain. Intervention 1: Intervention group: People in the intervention group, in addition to routine physiotherapy treatment, include 2 sessions per week for 5 weeks, a hot pack for 20 minutes, and ultrasound with a frequency of 1 MHz for 5 minutes, and TENS a frequency of 5 Hz for 15 minutes, and a shock wave for 2 sessions. Receives weekly for 5 weeks with intensityof 3, Frequency 10 and pulse 2000 for 7 minutes. Intervention 2: Control group: Control group two days a week for 5 weeks of routine physiotherapy treatment which includes a hot pack for 20 minutes and ultrasound with a frequency of 1 MHz for 5 minutes and TENS with a frequency of 5 Hz for 15 minutes with shock wave off. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no more information
public Dr. Rozita Hedayati
Semnan University of Medical Sciences and Health Services, Basij Boulevard, Semnan, Iran
Semnan Iran (Islamic Republic of) 3514799442 +98 23 3344 1022 rosehed@yahoo.com Semnan University of Medical Sciences scientific Seyed Ali Asghar Ashtiyani
Neuromuscular Rehabilitation Research Center, Next to Nemat Ice Cream, Quds Boulevard, Semnan, Iran
Semnan Iran (Islamic Republic of) 9837535196 +98 23 3332 8502 seyedashtiyani@gmail.com Semnan University of Medical Sciences Iran (Islamic Republic of) Age20-50 Have experienced back pain for at least more than 3 months The patient has an inability to function due to back pain The patient with low back pain has no history of lumbar surgery The patient's pain should be between 3 and 7 based on the visual pain questionnaire The patient has pain and trigger points in the gluteal area based on Travel and Simmons pain pattern Patient with gluteal muscle weakness on the dominant side compared to the healthy side based on manual muscle strength test (MMT) 20 years 50 years Both Symptoms of Horsetail Syndrome include: Changes in urinary and fecal control, Saddle anesthesia, General anesthesia and general numbness Any symptoms of a serious spinal involvement include: chest pain, extensive paresthesia in the limbs, weakness in the lower limbs Any major cognitive impairment and severe aphasia Spinal fractures Postural vertigo Pregnancy M54.5 Low back pain Rehabilitation Rehabilitation Intervention group: People in the intervention group, in addition to routine physiotherapy treatment, include 2 sessions per week for 5 weeks, a hot pack for 20 minutes, and ultrasound with a frequency of 1 MHz for 5 minutes, and TENS a frequency of 5 Hz for 15 minutes, and a shock wave for 2 sessions. Receives weekly for 5 weeks with intensityof 3, Frequency 10 and pulse 2000 for 7 minutes Control group: Control group two days a week for 5 weeks of routine physiotherapy treatment which includes a hot pack for 20 minutes and ultrasound with a frequency of 1 MHz for 5 minutes and TENS with a frequency of 5 Hz for 15 minutes with shock wave off. Static Balance. Timepoint: Sessions 1 and 10. Method of measurement: Biodex. Dynamic Balance. Timepoint: Sessions 1 and 10. Method of measurement: Biodex. Pain. Timepoint: Sessions 1 and 10. Method of measurement: VAS. Disability. Timepoint: Sessions 1 and 10. Method of measurement: Rolland-Morris. Approved 2022-01-29 Semnan University of Medical Sciences Semnan University of Medical Sciences and Health Services, Basij Street, Semnan, Iran Semnan Semnan Iran (Islamic Republic of)