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IRCT20260209068810N1 IRCT 2026-08-31 Artesh University of Medical Sciences effects of electroacupuncture on urinary disorders in patients with multiple sclerosis A comparison of the effects of electroacupuncture and posterior tibial nerve electrical stimulation on urinary disorders in patients with multiple sclerosis in Tehran Imamreza hospital 2026-10-01 anticipated 38 Pending https://irct.ir/trial/92740 interventional Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment. 2-3 Multiple sclerosis. Intervention 1: Intervention group: Treatment protocol for the first group: 12 sessions (two sessions per week for 6 weeks) Electrical stimulation of the posterior tibial nerve by placing a surface electrode behind the medial malleolus and a needle electrode 5 cm cephalad and 1.5 cm behind the medial malleolus with a stimulation frequency of 20 Hz, a pulse width of 200 milliseconds, a voltage of 9 mV, and the stimulation intensity is increased to the point of causing thumb flexion, and then the stimulation is reduced to the point of causing a burning sensation. The duration of each session is 20 to 30 minutes. Intervention 2: Intervention group: Treatment protocol for the second group: 12 sessions (two sessions per week for 6 weeks) of acupuncture with electrical stimulation at specific points related to urinary incontinence with a frequency of 20 Hz and the intensity of stimulation is at the level of a tingling sensation felt by the patient. The duration of each session is 20 to 30 minutes. Acupuncture points include:DU 20: Midline connecting the earlobesLI4: Midline of the FDI muscle, side of He8Ren3: One chin below the navelRen4: Two chins below the navel1.5 Ren6: Two chins below the navelRen7: One chin below the navelSP6: Three chins above the medial tip of the medial malleolus of the tibiaSP9: A hole inside the tibial tuberosity, almost on the posterior anserine bursaUB23: 1.5 chins lateral to the spinous process of the L2 vertebraUB28: 1.5 chins lateral to the spinous process of the S2 vertebraUB40: In the popliteal fossa and in the middle of the popliteal fossa. Yes - There is a plan to make this available What will be shared: All data is potentially shareable after de-identifying individuals. When: Access period begins after results are printed. To whom: Only for researchers working in academic and scientific institutions Conditions: The conditions mentioned above Where to obtain: Shadi Askari How to obtain: I haven't decided yet. Comments:
public Shadi Askari
No 49,mashahir Ave,ghaem magham Blvd,haftetir SQ
Tehran Iran (Islamic Republic of) 1589853113 +98 21 8881 6923 shadi.askari7@gmail.com Artesh University of Medical Sciences scientific seyed Morteza Tabatabae
West Fatemi Street, before reaching Shahid Chamran Highway, Etemadzadeh Street
Tehran Iran (Islamic Republic of) 1411718546 +98 21 8609 6350 smt.1368@gmail.com Artesh University of Medical Sciences Iran (Islamic Republic of) 18 years of age or older diagnosis of MS by a neurologist are stable in terms of disease progression (operationally no change in physical or mental symptoms in the past 4 months), no Exacerbation Disability Status Score (EDSS) less than 6. If taking antipsychotic medications, self-medication can be included only if the medication has been taken for at least 3 months prior to the study and has not changed during the study. have sufficient cognitive capacity to complete the assessment and treatment protocol 18 years no limit Both pregnancy, previous gynecological, urological, and/or neurosurgery, cesarean section or vaginal delivery in the past 6 months pelvic prolapse greater than stage I on the Pelvic Prolapse Quantification System (POP-Q) examination performed by a physical therapist urinary tract infection confirmed by laboratory tests, or self-reported perimenopause or menopause. f participants reported any worsening of their primary MS symptoms during the study, they were reassessed by a neurologist using the EDSS. They were excluded if their EDSS score increased by more than 0.5 from baseline during data collection. G35 Demyelinating diseases of the central nervous system Multiple sclerosisIncl.: Multiple sclerosis (of): NOS brain stem cord disseminated generalized Treatment - Devices Treatment - Devices Intervention group: Treatment protocol for the first group: 12 sessions (two sessions per week for 6 weeks) Electrical stimulation of the posterior tibial nerve by placing a surface electrode behind the medial malleolus and a needle electrode 5 cm cephalad and 1.5 cm behind the medial malleolus with a stimulation frequency of 20 Hz, a pulse width of 200 milliseconds, a voltage of 9 mV, and the stimulation intensity is increased to the point of causing thumb flexion, and then the stimulation is reduced to the point of causing a burning sensation. The duration of each session is 20 to 30 minutes. Intervention group: Treatment protocol for the second group: 12 sessions (two sessions per week for 6 weeks) of acupuncture with electrical stimulation at specific points related to urinary incontinence with a frequency of 20 Hz and the intensity of stimulation is at the level of a tingling sensation felt by the patient. The duration of each session is 20 to 30 minutes. Acupuncture points include:DU 20: Midline connecting the earlobesLI4: Midline of the FDI muscle, side of He8Ren3: One chin below the navelRen4: Two chins below the navel1.5 Ren6: Two chins below the navelRen7: One chin below the navelSP6: Three chins above the medial tip of the medial malleolus of the tibiaSP9: A hole inside the tibial tuberosity, almost on the posterior anserine bursaUB23: 1.5 chins lateral to the spinous process of the L2 vertebraUB28: 1.5 chins lateral to the spinous process of the S2 vertebraUB40: In the popliteal fossa and in the middle of the popliteal fossa Urinary symptoms Conceptual definition: Urinary disorders in patients with multiple sclerosis (MS) are a set of functional abnormalities in the bladder and urinary tract that occur mainly due to the involvement of the central nervous system in urinary control. These disorders often include symptoms such as urinary frequency, urgency, nocturia, and urinary incontinence. Operational definition: In this study, the presence of urinary disorders in patients with MS is determined based on the score obtained from the ICIQ-OAB questionnaire. This questionnaire is a valid and standardized tool for measuring symptoms of overactive bladder, which includes 4 main questions about urinary frequency during the day, urgency, nocturia, and urge incontinence, and each item is scored from 0 to 4 (maximum score 16). Timepoint: Before the intervention, the end of the intervention, and three months after the end. Method of measurement: ICIQ-OAB quastionare. Quality of life. Timepoint: Before the intervention, the end of the intervention, and three months after the end. Method of measurement: SF-12 quastionare. Physical health level. Timepoint: Before the intervention, the end of the intervention, and three months after the end. Method of measurement: ICIQ-OAB QuestionnairePart One. Level of mental health. Timepoint: Before the intervention, the end of the intervention, and three months after the end. Method of measurement: ICIQ-OAB QuestionnairePart Two. Artesh University of Medical Sciences Approved 2026-02-15 Ethics committee of Artesh University of Medical Sciences Haft Tir Square, Ghaem Maqam Street, Mashahir Street, No.49 Tehran Tehran Iran (Islamic Republic of)