This study is designed to investigate the clinical effectiveness of acupuncture combined with Interferon β-1a and Amantadine compared to IFN-β-1a and Amantadine alone on fatigue and quality of life of patients with relapsing-remitting multiple sclerosis in remission stage of disease.
Design
A randomized controlled parallel group trial on 60 patients with equal randomization (1:1 ratio) by Excel Rand function.
Settings and conduct
Study location: Heravi 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: being at the age of 18 years old and above; with relapsing-remitting multiple sclerosis; in remission stage of disease; fatigue severity scale greater than 4.
Non-inclusion criteria: History of other major primary disease (fatigue caused by a severe or malignant disease); acute relapse or corticosteroid therapy in the last 30 days before inclusion
Intervention groups
Intervention group: Acupuncture combined with Interferon β-1a (immunomodulator) and Amantadine (a medication used for fatigue in multiple sclerosis patients)
Control group: Only medications
Main outcome variables
Fatigue severity scale; quality of life
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180914041035N2
Registration date:2021-09-19, 1400/06/28
Registration timing:prospective
Last update:2021-09-19, 1400/06/28
Update count:0
Registration date
2021-09-19, 1400/06/28
Registrant information
Name
Amir Hooman Kazemi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2298 8548
Email address
hooman_k@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-09-23, 1400/07/01
Expected recruitment end date
2021-10-23, 1400/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the Effectiveness of Acupuncture Treatment with Routine Treatment on Fatigue among Patients with Multiple Sclerosis
Public title
Acupuncture effect in MS Associated Fatigue
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Multiple sclerosis patients
Relapsing remitting type
In remission stage of disease
Confirmed by a neurologist
Suffer from fatigue severity scale greater than or equal to 4
Age of 18 years old and above
Signing the written informed consent for participating in the study
Exclusion criteria:
History of other major primary disease (fatigue caused by a severe or malignant disease)
Acute relapse or corticosteroid therapy in the last 30 days before study
Cognitive impairment and inability of cooperation
Using any herbal or other alternative treatments
Pregnancy or breastfeeding
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
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)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of School of Medicine- Tehran University of Medical Sciences
Street address
No. 67, West Jamali Alley., Wafamanesh Avenue, Heravi Square
City
Tehran
Province
Tehran
Postal code
1668753961
Approval date
2021-08-14, 1400/05/23
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1400.542
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 Fatigue Severity
Timepoint
Fatigue Severity Scale (FSS) is evaluated before treatment, after 2 and 4 weeks.
Method of measurement
Fatigue Severity Scale Questionnaire
Secondary outcomes
1
Description
Score of Multiple sclerosis quality of life
Timepoint
Multiple sclerosis quality of life 54 (MSQOL-54) questionnaire is assessed before and after intervention.
Method of measurement
Multiple sclerosis quality of life 54 (MSQOL-54) questionnaire
Intervention groups
1
Description
Intervention group: The acupuncture group will receive acupuncture treatment through 10 sessions, 2-3 times per week (totally 4 weeks). All patients will also receive routine treatment with Interferon β-1a and Amantadine. According to textbooks and literature review, major selected acupoints for fatigue include Taixi (KI 3), Taichong (LR 3), Sanyinjiao (SP 6), Xuehai (SP 10), Zusanli (ST 36), Yanglingquan (GB 34), Guanyuan (CV 4), Qihai (CV 6), and Hegu (LI 4). Sterile stainless steel acupuncture needles (0.25mm × 40mm, Zhongyan Taihe medical instrument, Beijing, China) were inserted perpendicularly at a depth of 10-15 mm into the acupoints and will be retained for 20 minutes.
Category
Treatment - Other
2
Description
Control group: Control group will receive routine treatment with Interferon β-1a and Amantadine. IFN-β-1a (Avonex), 30 μg, is administered by intramuscular injection once every week. Amantadine 100mg will be used orally once a day.
Category
Treatment - Drugs
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
۱۴۱۷۶۵۳۷۶۱
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
Amir Hooman Kazemi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
No. 27, North Sarparast St, West Taleghani St, Felestin Square
City
Tehran
Province
Tehran
Postal code
۱۴۱۷۶۵۳۷۶۱
Phone
+98 21 2298 8548
Fax
Email
hooman_k@tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Amir Hooman Kazemi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
No. 27, North Sarparast St, West Taleghani St, Felestin Square
City
Tehran
Province
Tehran
Postal code
۱۴۱۷۶۵۳۷۶۱
Phone
+98 21 2298 8548
Fax
Email
hooman_k@tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Amir Hooman Kazemi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
No. 27, North Sarparast St, West Taleghani St, Felestin Square
City
Tehran
Province
Tehran
Postal code
۱۴۱۷۶۵۳۷۶۱
Phone
+98 21 2298 8548
Fax
Email
hooman_k@tums.ac.ir
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