This study is designed to investigate the clinical effectiveness of acupuncture combined with routine treatment to routine treatment alone on quality of life of patients with relapsing-remitting multiple sclerosis.
Design
A randomized controlled parallel group trial on 80 patients with equal randomization (1:1 ratio) by Excel Rand function.
Settings and conduct
Study location: Ahmadie Clinic; School of Persian Medicine; Tehran University of Medical Sciences.
Study Participants: The patients are recruited from Iran multiple sclerosis (MS) society in collaboration with MS Research Institute of Sina Hospital. In this study blinding is not applied.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Male or female patients aged 18 to 65 with relapsing-remitting multiple sclerosis, at least 6 months have passed since their definitive diagnosis and have not been treated with steroids or any other complementary medicine treatment in the last 3 months.
No-entry criteria: Having an underlying disease or not being able to come regularly to receive treatment.
Intervention groups
Intervention group: Acupuncture plus routine treatment
Control group: Routine treatment alone
Main outcome variables
Quality of life
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20171007036614N5
Registration date:2024-04-03, 1403/01/15
Registration timing:prospective
Last update:2024-04-03, 1403/01/15
Update count:0
Registration date
2024-04-03, 1403/01/15
Registrant information
Name
Mohammad Sadegh Adel-Mehraban
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3624 3214
Email address
sadeghadel@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-05-21, 1403/03/01
Expected recruitment end date
2025-05-22, 1404/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of acupuncture on the quality of life of patients with multiple sclerosis (MS): randomized controlled clinical trial
Public title
Effect of acupuncture on MS quality of life
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
RRMS patients with at least 6 months after definite diagnosis
Exclusion criteria:
Receiving other complementary treatments past 3 months
Receiving steroids in past 3 months
Other underlying disease
Inability to attend acupuncture sessions regularly
Age
From 18 years old to 65 years old
Gender
Both
Phase
2-3
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be randomized equally to intervention and control groups by simple individualized randomization method. For allocation of the participants, an Excel generated list of random numbers will be used. The allocation sequence will be concealed in sealed, opaque envelopes. After the initial evaluation and obtaining the written consent of enrolled participants, the corresponding envelopes will be opened, and the treatment allocation will be revealed.
Blinding (investigator's opinion)
Single blinded
Blinding description
The person who measures the intended outcomes and the person who analyzes the statistics will be unaware of the type of intervention.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of Neuroscience Institute - Tehran University of Medical Sciences
Street address
Emam Khomeini St.
City
Tehran
Province
Tehran
Postal code
1136746911
Approval date
2024-02-24, 1402/12/05
Ethics committee reference number
IR.TUMS.NI.REC.1402.055
Health conditions studied
1
Description of health condition studied
Multiple sclerosis
ICD-10 code
G35
ICD-10 code description
Multiple sclerosis
Primary outcomes
1
Description
Score of quality of life
Timepoint
Before intervention and 8 weeks after intervention
Method of measurement
Multiple sclerosis quality of life 54 (MSQOL-54) questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Intervention group: Patients come for acupuncture for 8 weeks (2 times a week for the first 4 weeks and 1 time a week for the second 4 weeks, a total of 12 sessions). The acupuncture protocol is manual acupuncture and the points used will be ST36, ST, 40, LR2, LR3, KD3, KD6, CV4, CV6, GV20, GV24, shenmen, Yintang. All patients, including the control group, receive the routine treatment. Sterile stainless acupuncture needles (0.25 mm × 40 mm, manufactured by Zhong Yang Taihe China Co., Ltd.) are inserted vertically at a depth of 10-15 mm into the acupuncture points and left for 20 minutes.
Category
Treatment - Other
2
Description
Control group: The control group receives only the routine treatment.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Sina hospital
Full name of responsible person
Abdolreaza Naser Moghadasi
Street address
Emam Khomeini St.
City
Tehran
Province
Tehran
Postal code
1136746911
Phone
+98 21 6634 8500
Email
abdorrezamoghadasi@gmail.com
2
Recruitment center
Name of recruitment center
Ahmadie clinid
Full name of responsible person
Amir Hooman Kazemi
Street address
Taleqani St.
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8897 4535
Email
amirhoomank@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Ali Akbari Sari
Street address
Enqelab St., Tehran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1417613151
Phone
+98 21 8897 8745
Email
info@tpcf.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Mohammad Sadegh Adel Mehraban
Position
PhD student
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
Taleqani St., Ahmadie Clinic
City
Tehran
Province
Tehran
Postal code
1417613151
Phone
+98 21 8897 4535
Email
sadeghadel@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Amirhooman Kazemi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
Taleqani St., Ahmadie clinic
City
Tehran
Province
Tehran
Postal code
1417613151
Phone
+98 21 8897 4535
Email
amirhoomank@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammad Sadegh Adel Mehraban
Position
PhD student
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
Taleqani St., Ahmadie Clinic
City
Tehran
Province
Tehran
Postal code
1417613151
Phone
+98 21 8897 4535
Email
sadeghadel@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be 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
Not applicable
Informed Consent Form
No - There is not 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