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IRCT20121228011912N8 IRCT 2024-03-22 Mashhad University of Medical Sciences Effect of Thread Embedding Acupuncture on Spasticity of M.S Comparison of the Effectiveness of True and Sham Thread Embedding Acupuncture on Spasticity in Multiple Sclerosis Patients 2024-04-03 anticipated 38 Complete https://irct.ir/trial/74172 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Other design features: The control group in acupuncture studies is called sham. Embedding studies are limited and the use of sham is not common in them. In this study, the sham is designed in such a way that all the embedding steps are performed, but the thread is not placed in the body tissue, Randomization description: Using the online site www.sealedenvelope.com, random allocation is done in two groups A (intervention) and group B (control). Block Randomization will be done with block sizes of 4 and 6 for random allocation. The prepared blocks will be placed inside the envelope. One of the envelopes will be randomly selected according to the order of patients' arrival, and patients will be assigned to groups. Allocation concealment is done using sealed opaque envelopes. By one of the team members, random numbers will be prepared and placed inside the envelope. The envelopes will be closed and their contents will not be visible from the outside. First, the purpose of the study is explained to the person with entry requirement critrias. Then, the person signs the informed consent form and one envelope will be taken and opened and patient will be entered into one of the two groups, Blinding description: In this study, the intervention group is True embedding group and the Sham group is designed as a control group, and the participants are thus blinded. The statistical analyst evaluates the information based on group A and B and is blinded to which group is belongs to A or B. 3 Multiple sclerosis (M.S). Intervention 1: Intervention group: True 2cm Polydioxanon Thread Embedding Acupuncture in 30 acupoints (GV14, GV20, CV4, CV12, BL18, BL20, BL23, SP6, SP9, ST36, KI3, GB20, GB34, LI11 , LR3, LI4, BL57) in one session after disinfection. Intervention 2: Control group: Sham group, Needling of 30 acupoints mentioned above without embedded thread in one session. 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 further information.
public Malika Vaez Tehrani
Traditional and Complementary Medicine Faculty, Shahid Kharazmi Complex, Mashhad University of Medical Science Campus, Azadi Square
Mashhad Iran (Islamic Republic of) 9177899191 +98 51388489316 Vaeztehrany@gmail.com Mashhad University of Medical Sciences scientific Hamidreza Bahrami Taghanaki
Traditional and Complementary Medicine Faculty, Shahid Kharazmi Complex, Mashhad University of Medical Science Campus, Azadi Square
Mashhad Iran (Islamic Republic of) 9177899191 +98 51388489316 bahramihr@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Definitive diagnosis of MS based on McDonald's 2024 criteria by a neurologist EDSS<7 Moderate to severe spasticity reported by the patient as NRS scoreā‰„4 with poor response to usual antispasmodics Willingness to participate in the study and sign informed consent Not taking anticoagulants No history of any coagulopathy No history of acupuncture in the last 6 months No history of relapse phase in the last 2 months No change in maintenance treatments during the last 2 months No history of sensivity to cephalosporins No history of sensivity to each components of the thread No history of incurable chronic systemic diseases and cancers Not being pregnant or breastfeeding and using a safe contraceptive method 18 years no limit Both Imbalance to continue cooperation with the study Incidence of sensivity reaction to the embedded thread Incidence of resistant bleeding requires medicinal intervention Incidence of the relapse phase requires receiving a medicinal pulse G35 Multiple sclerosis Rehabilitation Placebo Intervention group: True 2cm Polydioxanon Thread Embedding Acupuncture in 30 acupoints (GV14, GV20, CV4, CV12, BL18, BL20, BL23, SP6, SP9, ST36, KI3, GB20, GB34, LI11 , LR3, LI4, BL57) in one session after disinfection Control group: Sham group, Needling of 30 acupoints mentioned above without embedded thread in one session Disability Status Score. Timepoint: Before intervention and 4 and 12 weeks after intervention. Method of measurement: Expanded Disability Status Scale (EDSS). Spasticity Score. Timepoint: Before intervention and 4 and 12 weeks after intervention. Method of measurement: Numerical Rating Scale (NRS). Quality of Walking Score. Timepoint: Before intervention and 4 and 12 weeks after intervention. Method of measurement: Multiple Sclerosis Walking Scale-12 (MSWS-12). Activities of Daily Living (ADL) Score. Timepoint: Before intervention and 4 and 12 weeks after intervention. Method of measurement: Barthel Index. Pain Score. Timepoint: Before intervention and 4 and 12 weeks after intervention. Method of measurement: McGill pain questionnaire. Fatigue Score. Timepoint: Before intervention and 4 and 12 weeks after intervention. Method of measurement: Modified Fatigue Impact Scale (MFIS) questionnaire. Quality of Sleep score. Timepoint: Before intervention and 4 and 12 weeks after intervention. Method of measurement: Pittsburgh Sleep Quality Index (PSQI-P). Urinary Symptoms Score. Timepoint: Before intervention and 4 and 12 weeks after intervention. Method of measurement: Actionable Bladder Symptom Screening Tool (ABSST). Depression Score. Timepoint: Before intervention and 4 and 12 weeks after intervention. Method of measurement: Hospital Anxiety and Depression Scale (HADS) questionnaire. Quality of Life Score. Timepoint: Before intervention and 4 and 12 weeks after intervention. Method of measurement: EuroQoL Quality of Life questionnaire. Intervention Satisfaction Score. Timepoint: Before intervention and 4 and 12 weeks after intervention. Method of measurement: Scoring (1-10) for satisfaction with the treatment outcomes, willingness to repeat the treatment, and recommendation to other patients. Mashhad University of Medical Sciences Approved 2024-03-09 Ethics committee of Mashhad University of Medical Sciences Ghoreyshi complex, University Ave Mashhad Razavi Khorasan Iran (Islamic Republic of)