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
To investigate the effect of acupuncture with electrical stimulation (EA) compared with electrical stimulation of the posterior tibial nerve (PTNS) in urinary disorders in patients with multiple sclerosis
Design
Phase 3 randomized, parallel-group clinical trial (using a random number table) on 38 patients
Settings and conduct
protocol for the first group: 12 sessions 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, /protocol for the second group: 12 sessions stimulation at specific points related to urinary incontinence with a frequency of 20 Hz
Participants/Inclusion and exclusion criteria
Inclusion: Individuals 18 years of age or older / diagnosed with MS by a neurologist who are stable in terms of disease progression (operationally without change in physical or mental symptoms in the past 4 months) / have an EDSS score of less than 6.5 / have sufficient cognitive capacity to complete the evaluation and treatment protocol Exclusion: Pregnancy, previous gynecological, urological and/or neurosurgery, cesarean section or vaginal delivery in the past 6 months, pelvic organ prolapse greater than stage I / have a urinary tract infection / increase in EDSS score of more than 0.5 from baseline
Intervention groups
The first intervention group examined the effect of electroacupuncture/the second intervention group examined the effect of PTNS.
Main outcome variables
Age/Gender/Urinary Symptoms/Quality of Life/Intervention/Level of Physical Health/Level of Mental Health
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20260209068810N1
Registration date:2026-08-31, 1405/06/09
Registration timing:prospective
Last update:2026-08-31, 1405/06/09
Update count:0
Registration date
2026-08-31, 1405/06/09
Registrant information
Name
Shadi Askari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8881 6923
Email address
shadi.askari7@gmail.com
Recruitment status
Not yet recruiting
Funding source
Expected recruitment start date
2026-10-01, 1405/07/09
Expected recruitment end date
2027-03-19, 1405/12/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
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
Public title
effects of electroacupuncture on urinary disorders in patients with multiple sclerosis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
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
Exclusion criteria:
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.
Age
From 18 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
38
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Artesh University of Medical Sciences
Street address
Haft Tir Square, Ghaem Maqam Street, Mashahir Street, No.49
City
Tehran
Province
Tehran
Postal code
1589863113
Approval date
2026-02-15, 1404/11/26
Ethics committee reference number
IR.AJAUMS.REC.1404.351
Health conditions studied
1
Description of health condition studied
Multiple sclerosis
ICD-10 code
G35
ICD-10 code description
Demyelinating diseases of the central nervous system Multiple sclerosisIncl.: Multiple sclerosis (of): NOS brain stem cord disseminated generalized
Primary outcomes
1
Description
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
2
Description
quality of life
Timepoint
Before the intervention, the end of the intervention, and three months after the end
Method of measurement
SF-12 quastionare
3
Description
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
4
Description
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
Secondary outcomes
empty
Intervention groups
1
Description
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.
Category
Treatment - Devices
2
Description
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
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Tehran Imamreza hospital
Full name of responsible person
Shadi Askari
Street address
West Fatemi Street, Aitmadzadeh Street
City
Tehran
Province
Tehran
Postal code
1411718546
Phone
+98 21 8609 6352
Email
shadi.askari7@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Artesh University of Medical Sciences
Full name of responsible person
Dr. Armin Zareian
Street address
Tehran - West Fatemi Street - Shahid Etemadzadeh Street
City
Tehran
Province
Tehran
Postal code
۱۴۱۱۷۱۸۵۴۱
Phone
+98 21 8609 6350
Email
ajaums@gmail.com
Web page address
https://www.ajaums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Artesh University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Artesh University of Medical Sciences
Full name of responsible person
Shadi Askari
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Physical Medicine
Street address
No 49,mashahir Ave,ghaem magham Blvd,haftetir SQ
City
Tehran
Province
Tehran
Postal code
1589853113
Phone
+98 21 8881 6923
Fax
Email
shadi.askari7@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Artesh University of Medical Sciences
Full name of responsible person
seyed Morteza Tabatabae
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Physical Medicine
Street address
West Fatemi Street, before reaching Shahid Chamran Highway, Etemadzadeh Street
City
Tehran
Province
Tehran
Postal code
1411718546
Phone
+98 21 8609 6350
Email
smt.1368@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Artesh University of Medical Sciences
Full name of responsible person
Shadi Askari
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Physical Medicine
Street address
No 49,mashahir Ave,ghaem magham Blvd,haftetir SQ
City
Tehran
Province
Tehran
Postal code
1589863113
Phone
+98 21 8881 6923
Fax
Email
shadi.askari7@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
All data is potentially shareable after de-identifying individuals.
When the data will become available and for how long
Access period begins after results are printed.
To whom data/document is available
Only for researchers working in academic and scientific institutions
Under which criteria data/document could be used
The conditions mentioned above
From where data/document is obtainable
Shadi Askari
What processes are involved for a request to access data/document