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

January 29, 2024 updated by: Zeynep İnce, Ankara City Hospital Bilkent
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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Zeynep İNCE KESKİN, Medical doctor

Study Locations

  • Turkey
    • Bilkent-Cankaya
      • Ankara, Bilkent-Cankaya, Turkey, 06800
        • Recruiting
        • Ankara Bilkent City Hospital Physical Therapy and Rehabilitation Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: conventional rehabilitation
20 multiple sclerosis patients will receive conventional rehabilitation
Other: Conventional Rehabilitation
20 patients with multiple sclerosis meeting the criteria will undergo conventional rehabilitation
Active Comparator: conventional rehabilitation and acupuncture
20 multiple sclerosis patients will receive conventional rehabilitation and acupuncture treatment.
Other: Acupuncture
20 patients with multiple sclerosis meeting the criteria will undergo conventional rehabilitation and acupuncture treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Timed 25 Foot Walk Test Score
Time Frame: 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
Baseline, after 1 month and 3 month changes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Neurogenic Bladder Symptom Scoring
Time Frame: 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
Baseline, after 1 month and 3 month changes
Incontinence Quality of Life Questionnaire
Time Frame: 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
Baseline, after 1 month and 3 month changes
Multiple Sclerosis Quality of Life-54 (MSQOL-54)
Time Frame: 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
Baseline, after 1 month and 3 month changes
Fatigue Severity Scale
Time Frame: 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.
Baseline, after 1 month and 3 month changes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ankara City Hospital Bilkent

Investigators

  • Principal Investigator: Zeynep İNCE KESKİN, Medical Doctor, Ankara Bilkent City Hospital
  • Study Director: Müyesser ARAS, Professor Doctor, Ankara Bilkent City Hospital
  • Study Chair: Semra MUNGAN, Associate Professor, Ankara Bilkent City Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 18, 2023

Primary Completion (Estimated)

January 31, 2024

Study Completion (Estimated)

April 15, 2024

Study Registration Dates

First Submitted

November 6, 2023

First Submitted That Met QC Criteria

December 18, 2023

First Posted (Actual)

December 20, 2023

Study Record Updates

Last Update Posted (Actual)

January 30, 2024

Last Update Submitted That Met QC Criteria

January 29, 2024

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10026391

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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