Multiple sclerosis (M.S). Multiple sclerosis
Conditions
Interventions
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)
Sponsors
Mashhad University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Definitive diagnosis of MS based on McDonald's 2017 criteria by a neurologist EDSS<7 Moderate to severe spasticity reported by the patient as NRS score=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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactMalika Vaez Tehrani
Mashhad University of Medical Sciences
Outcome results
None listed