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Completed

NCT Number: NCT06178029

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

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

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Fatigue Immune System Diseases Nervous System Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ankara Bilkent City Hospital Physical Therapy and Rehabilitation Hospital

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

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Acupuncture

Other

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

conventional rehabilitation

Other

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

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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.

Sponsors and collaborators

Lead sponsor

Ankara City Hospital Bilkent

Other

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Dec 20, 2023
Registry last updated
Jul 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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