Effectiveness of Acupuncture Treatment Applied in Addition to the Rehabilitation Program in Multiple Sclerosis Patients

Not Applicable

Completed

• Conditions: Multiple Sclerosis
• Interventions: Other: Acupuncture; Other: Conventional Rehabilitation

• Registration Number: NCT06178029
• Lead Sponsor: Ankara City Hospital Bilkent

Brief Summary

The purpose of the study is to assess the effect of acupuncture treatment combinated with conventional rehabilitation methods on gait, fatigue, quality of life and bladder functions in patients with multiple sclerosis

Detailed Description

After being informed about study and potential risks, all patient giving written informed consent will undergo screening period determine eligibility for study entry. The patients who meet the eligibility recruitments will get treatment into two groups in a conventional rehabilitation and acupuncture combined with conventional rehabilitation

Study Timeline

• Study Start: 2023-06-18
• Study First Submitted: 2023-11-06
• Study First Submitted QC: 2023-12-18
• Study First Posted: 2023-12-20
• Primary Completion: 2024-01-31
• Study Completion: 2024-04-15
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-11
• Last Update Posted: 2024-07-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Being diagnosed with MS according to McDonald criteria
• EDSS score between 1-6
• The patient is clinically stable
• Having not had a new MS attack in the last 3 months
• Being cognitively suitable to participate in the study

Exclusion Criteria

• Being clinically unstable
• Inability to cognitively participate in tests
• Having received acupuncture treatment in the last 6 months

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
conventional rehabilitation and acupuncture	Acupuncture	20 multiple sclerosis patients will receive conventional rehabilitation and acupuncture treatment.
conventional rehabilitation	Conventional Rehabilitation	20 multiple sclerosis patients will receive conventional rehabilitation

Primary Outcome Measures

Name	Time	Method
Timed 25 Foot Walk Test Score	Baseline, after 1 month and 3 month changes	The Timed 25 Foot Walk test assesses a patient's ability to walk 25 feet distance.Patient's walking speed in m/s calculate

Secondary Outcome Measures

Name	Time	Method
Neurogenic Bladder Symptom Scoring	Baseline, after 1 month and 3 month changes	The Neurogenic Bladder Symptom Score (NBSS) is a validated 24 item questionnaire that measures bladder symptoms across 3 different domains: incontinence (scored 0-29), storage and voiding (scored 0-22), and consequences (scored 0-23); there is a single general urinary QOL question scored from 0 (pleased) to 4 (unhappy). For all domains, a higher score represents a worse symptom burden or QOL
Fatigue Severity Scale	Baseline, after 1 month and 3 month changes	The FAS is a 10-item scale evaluating symptoms of chronic fatigue. As the score increases in FAS, the severity of the patient's fatigue also increases.
Incontinence Quality of Life Questionnaire	Baseline, after 1 month and 3 month changes	There are 22 questions. The 22 items can be further grouped into 3 subscales: Avoidance and Limiting Behaviour (8 items), Psychosocial Impacts (9 items), and Social Embarrassment (5 items). The total I-QOL and 3 subscale scores are calculated by summing the unweighted item score and transforming them to a 100 point scale where 0 = most severe, and 100 = no problem . The instrument has been widely used and has been successfully validated for people with uriner incontinence
Multiple Sclerosis Quality of Life-54 (MSQOL-54)	Baseline, after 1 month and 3 month changes	The MSQOL-54 is a multidimensional health-related quality of life measure that combines both generic and MS-specific items into a single instrument

Trial Locations

Locations (1)

Ankara Bilkent City Hospital Physical Therapy and Rehabilitation Hospital; 🇹🇷 Ankara, Bilkent-Cankaya, Turkey