Effect of Thread Embedding Acupuncture on Spasticity of M.S

Phase 3

Recruiting

Conditions: Multiple sclerosis (M.S).
Multiple sclerosis

Registration Number: IRCT20121228011912N8

Lead Sponsor: Mashhad University of Medical Sciences

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 38

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

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

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.