NCT06178029

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable multiple-sclerosis

Timeline
Completed

Started Jun 2023

Shorter than P25 for not_applicable multiple-sclerosis

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 18, 2023

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

November 6, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 20, 2023

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 15, 2024

Completed
Last Updated

July 12, 2024

Status Verified

July 1, 2024

Enrollment Period

8 months

First QC Date

November 6, 2023

Last Update Submit

July 11, 2024

Conditions

Multiple Sclerosis

Keywords

AcupunctureGaitFatigue

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Neurogenic Bladder Symptom Scoring

    Baseline, after 1 month and 3 month changes

  • Incontinence Quality of Life Questionnaire

    Baseline, after 1 month and 3 month changes

  • Multiple Sclerosis Quality of Life-54 (MSQOL-54)

    Baseline, after 1 month and 3 month changes

  • Fatigue Severity Scale

    Baseline, after 1 month and 3 month changes

Study Arms (2)

conventional rehabilitation

ACTIVE COMPARATOR

20 multiple sclerosis patients will receive conventional rehabilitation

Other: Conventional Rehabilitation

conventional rehabilitation and acupuncture

ACTIVE COMPARATOR

20 multiple sclerosis patients will receive conventional rehabilitation and acupuncture treatment.

Other: Acupuncture

Interventions

AcupunctureOTHER

20 patients with multiple sclerosis meeting the criteria will undergo conventional rehabilitation and acupuncture treatment.

conventional rehabilitation and acupuncture
Conventional RehabilitationOTHER

20 patients with multiple sclerosis meeting the criteria will undergo conventional rehabilitation

conventional rehabilitation

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara Bilkent City Hospital Physical Therapy and Rehabilitation Hospital

Ankara, Bilkent-Cankaya, 06800, Turkey (Türkiye)

Location

Related 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.

    PMID: 28410453RESULT

MeSH Terms

Conditions

Multiple SclerosisFatigue

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeutics

Study Officials

  • Zeynep İNCE KESKİN, Medical Doctor

    Ankara City Hospital Bilkent

    PRINCIPAL INVESTIGATOR

  • Müyesser ARAS, Professor Doctor

    Ankara City Hospital Bilkent

    STUDY DIRECTOR

  • Semra MUNGAN, Associate Professor

    Ankara City Hospital Bilkent

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Doctor

Study Record Dates

First Submitted

November 6, 2023

First Posted

December 20, 2023

Study Start

June 18, 2023

Primary Completion

January 31, 2024

Study Completion

April 15, 2024

Last Updated

July 12, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)