To evaluate the effectiveness of acupuncture compared to sham acupuncture on cognitive functioning of relapsing remitting multiple sclerosis (RRMS) patients
Design
Block randimized double blind sham controlled clinical trial with a parallel group design of 60 patients. For randomization Excel RAND function will be used
Settings and conduct
Study location: Sina Hospital, Tehran University of Medical Sciences
Patients are collected from MS Clinic of Sina Hospital . Preliminary assessments are performed at MS Research Center of Sina Hospital, and then participants visit the Sina MS Clinic twice a week for acupuncture treatments.
Patients and the psychologist evaluating the primary outcome are blinded to assignment of patients to intervention and control groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Relapsing remitting multiple sclerosis patients; aged 18 to 55 years; with expanded disability status scale < 5.5. Non-inclusion criteria: History of other severe or malignant disease; Acute relapse or corticosteroid therapy in the last 30 days before inclusion
Intervention groups
Intervention group: Acupuncture treatment twice a week for 24 sessions (12 weeks). Control group: sham acupuncture; tiny needles will be inserted very shallow (1-2 mm) at nonspecific locations, with no known acupuncture influence, not on any known meridian at least 2 centimetres away from the actual acupuncture points
Main outcome variables
Brief International Cognitive Assessment for multiple sclerosis (BICAMS); Pittsburgh Sleep Quality index (PSQI); Symptom Checklist 90- Revised (SCL-90-R); Fatigue Severity scale (FSS)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220101053582N1
Registration date:2022-01-04, 1400/10/14
Registration timing:prospective
Last update:2022-01-04, 1400/10/14
Update count:0
Registration date
2022-01-04, 1400/10/14
Registrant information
Name
Abdorreza Naser Moghadasi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 937 438 1919
Email address
abdorrezamoghadasi@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-01-21, 1400/11/01
Expected recruitment end date
2022-06-22, 1401/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the Effectiveness of Acupuncture with Sham Acupuncture on Cognitive Functioning in Multiple Sclerosis Patients
Public title
Acupuncture and Cognitive Impairment in MS
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with relapsing-remitting multiple sclerosis
Expanded disability status scale (EDSS) ≤ 5.5
Age 18 to 55 years
Sign the written informed consent
Exclusion criteria:
History of cognitive impairment caused by other chronic or malignant disease
Acute relapse or corticosteroid therapy in the last 30 days before inclusion
Previous use of acupuncture or using any herbal or other alternative treatments
Pregnancy or breastfeeding
Age
From 18 years old to 55 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Participants will be randomized to acupuncture and sham acupuncture groups by block randomization method. Random blocks with size of four are generated by Excel Rand function. Allocations are placed inside sealed folders. After the researcher has assessed eligibility, obtained the patient’s consent, and completed all baseline assessments of the enrolled participants, folders are opened and allocation of treatment for the patients will be determined.
Blinding (investigator's opinion)
Double blinded
Blinding description
The patients and interviewer who measures the outcomes will be blinded to the randomization status. It is not possible to blind the acupuncturist due to the nature of the intervention. Blinding also will be maintained for data management, outcome assessment and data analysis.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of Neuroscience Institute
Street address
Room No. 605, 6th floor, Tehran University of Medical Sciences, Keshavarz Blvd. Tehran
City
Tehran
Province
Tehran
Postal code
1417653761
Approval date
2021-12-08, 1400/09/17
Ethics committee reference number
IR.TUMS.NI.REC.1400.061
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 cognitive functioning assessment test
Timepoint
Measurement of cognitive function before the intervention and after 24 sessions of acupuncture during 12 weeks
Method of measurement
Brief International Cognitive Assessment for multiple sclerosis (BICAMS) questionnaire
Secondary outcomes
1
Description
Score of Sleep Quality index
Timepoint
Before the intervention and after 24 sessions of acupuncture during 12 weeks
Method of measurement
Pittsburgh Sleep Quality index questionnaire
2
Description
Score of psychological problems checklist
Timepoint
Before the intervention and after 24 sessions of acupuncture during 12 weeks
Method of measurement
Symptom Checklist 90- Revised questionnaire
3
Description
Score of fatigue severity
Timepoint
Before the intervention and after 24 sessions of acupuncture during 12 weeks
Method of measurement
Fatigue severity scale questionnaire
Intervention groups
1
Description
Intervention group: The acupuncture group will receive acupuncture treatment 2 times per week for 12 weeks (24 sessions). Patients will receive their routine medications for MS. Major selected acupoints for cognitive dysfunction include Baihui (GV 20), Sishencong (EX-HN 1), Shenting (GV 24), Yintang (GV 29), Fengchi (GB 20), Zhongwan (CV 12), Tianshu (ST 25), Qihai (CV 6), Guanyuan (CV 4), Neiguan (PC 6), Shenmen (HT 7), Zusanli (ST 36), Sanyinjiao (SP 6), Taixi (KI 3) and Taichong (LR 3). Sterile stainless steel acupuncture needles (0.25 x 40 mm, Huan-Qiu, Japan) will be inserted 5-30 mm into selected acupoints with even manipulation method and will be retained for 30 minutes.
Category
Treatment - Other
2
Description
Control group: In sham acupuncture group, tiny needles (0.16 x 13 mm) will be inserted very shallow (1-2 mm) without manipulation at nonspecific locations, with no known acupuncture influence, not on any known meridian at least 2 centimetres away from the actual acupuncture points. Patients will receive their routine medications for MS.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Sina Hospital
Full name of responsible person
Faezeh Khodaie
Street address
Sina Hospital, Imam Khomeini Ave.
City
Tehran
Province
Tehran
Postal code
1136746911
Phone
+98 21 6634 8571
Email
faezeh.khodaie@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammad Ali Sahraian
Street address
6th Floor, Tehran University of Medical Sciences, Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8163 3698
Email
vcr@tums.ac.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
Faezeh Khodaie
Position
Research assistant
Latest degree
Medical doctor
Other areas of specialty/work
Neurology
Street address
MS research center, Sina Hospital, Imam Khomeini Ave.
City
Tehran
Province
Tehran
Postal code
1136746911
Phone
+98 21 6634 8571
Email
faezeh.khodaie@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Faezeh Khodaie
Position
Research assistant
Latest degree
Medical doctor
Other areas of specialty/work
Neurology
Street address
MS research center, Sina Hospital, Imam Khomeini Ave.
City
Tehran
Province
Tehran
Postal code
1136746911
Phone
+98 21 6634 8571
Email
faezeh.khodaie@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Faezeh Khodaie
Position
Research assistant
Latest degree
Medical doctor
Other areas of specialty/work
Neurology
Street address
MS research center, Sina Hospital, Imam Khomeini Ave.
City
Tehran
Province
Tehran
Postal code
1136746911
Phone
+98 21 6634 8571
Email
faezeh.khodaie@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
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