]>
IRCT20220101053582N1 IRCT 2022-01-04 Tehran University of Medical Sciences Acupuncture and Cognitive Impairment in MS Comparison of the Effectiveness of Acupuncture with Sham Acupuncture on Cognitive Functioning in Multiple Sclerosis Patients 2022-01-21 anticipated 60 Complete https://irct.ir/trial/60998 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, 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 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. N/A Multiple Sclerosis. Intervention 1: 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. Intervention 2: 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. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no more information
public Faezeh Khodaie
MS research center, Sina Hospital, Imam Khomeini Ave.
Tehran Iran (Islamic Republic of) 1136746911 +98 21 6634 8571 faezeh.khodaie@gmail.com Tehran University of Medical Sciences scientific Faezeh Khodaie
MS research center, Sina Hospital, Imam Khomeini Ave.
Tehran Iran (Islamic Republic of) 1136746911 +98 21 6634 8571 faezeh.khodaie@gmail.com Tehran University of Medical Sciences Iran (Islamic Republic of) Patients with relapsing-remitting multiple sclerosis Expanded disability status scale (EDSS) ≤ 5.5 Age 18 to 55 years Sign the written informed consent 18 years 55 years Both 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 G35 Multiple sclerosis Treatment - Other Other 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. 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. 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. 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. 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. Score of fatigue severity. Timepoint: Before the intervention and after 24 sessions of acupuncture during 12 weeks. Method of measurement: Fatigue severity scale questionnaire. Tehran University of Medical Sciences Approved 2021-12-08 Research Ethics Committees of Neuroscience Institute Room No. 605, 6th floor, Tehran University of Medical Sciences, Keshavarz Blvd. Tehran Tehran Tehran Iran (Islamic Republic of)