Comparison of the Effectiveness of Acupuncture Treatment With Conventional Rehabilitation Methods in Multiple Sclerosis Patients

Multiple Sclerosis Clinical Trial

Official title:

Comparison of the Effectiveness of Acupuncture Treatment With Conventional Rehabilitation Methods in Multiple Sclerosis Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06178029
• Other study ID #: 10026391
• Status: Recruiting
• Phase: N/A
• Start date: June 18, 2023
• Est. completion date: April 15, 2024

Study information

• Verified date: December 2023
• Source: Ankara City Hospital Bilkent
• Contact: Müyesser ARAS, Professor Doctor
• Phone: +905055839103
• Email: drmuyesser[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: April 15, 2024
• Est. primary completion date: January 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Other:
• Acupuncture
20 patients with multiple sclerosis meeting the criteria will undergo conventional rehabilitation and acupuncture treatment.
• Conventional Rehabilitation
20 patients with multiple sclerosis meeting the criteria will undergo conventional rehabilitation

Locations

Country	Name	City	State
Turkey	Ankara Bilkent City Hospital Physical Therapy and Rehabilitation Hospital	Ankara	Bilkent-Cankaya

Sponsors (1)

Lead Sponsor	Collaborator
Ankara City Hospital Bilkent

Country where clinical trial is conducted

Turkey, 

References & Publications (1)

Criado MB, Santos MJ, Machado J, Goncalves AM, Greten HJ. Effects of Acupuncture on Gait of Patients with Multiple Sclerosis. J Altern Complement Med. 2017 Nov;23(11):852-857. doi: 10.1089/acm.2016.0355. Epub 2017 Apr 14. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Timed 25 Foot Walk Test Score	The Timed 25 Foot Walk test assesses a patient's ability to walk 25 feet distance.Patient's walking speed in m/s calculate	Baseline, after 1 month and 3 month changes
Secondary	Neurogenic Bladder Symptom Scoring	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	Baseline, after 1 month and 3 month changes
Secondary	Incontinence Quality of Life Questionnaire	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	Baseline, after 1 month and 3 month changes
Secondary	Multiple Sclerosis Quality of Life-54 (MSQOL-54)	The MSQOL-54 is a multidimensional health-related quality of life measure that combines both generic and MS-specific items into a single instrument	Baseline, after 1 month and 3 month changes
Secondary	Fatigue Severity Scale	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.	Baseline, after 1 month and 3 month changes