A Study to Analyze the Effect of Acupuncture on Mobility And Quality of Life in Multiple Sclerosis

NCT ID: NCT03174379

Last Updated: 2022-03-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

13 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-06-05

Study Completion Date

2019-06-06

Brief Summary

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The purpose of this two-center study is to examine the effectiveness of acupuncture treatments in addressing mobility deficits, sensorimotor impairment, and quality of life (QOL) limitations in persons with Multiple Sclerosis (MS). It is hypothesized that acupuncture will result in an improvement in these limitations.

Detailed Description

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This research study will examine the effects of acupuncture on various symptoms experienced by persons with MS. Persons with MS often use acupuncture as a way of controlling the symptoms of the disease. However, there is little research on whether or not acupuncture has any effect on MS symptoms related to movement. This study intends to look at the effects of acupuncture treatment on walking, balance, and mood in persons with MS.

Conditions

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Multiple Sclerosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Control Group

Standard of Care (SOC) treatment will be based upon Traditional Chinese Medicine (TCM) interpretation of 4 phases of MS.

Group Type PLACEBO_COMPARATOR

Standard of Care with no acupuncture

Intervention Type PROCEDURE

The control group will lie on a treatment table in the acupuncturist's office for the same amount of time that the treatment group did, but receive no acupuncture

Treatment Group

60-minute treatment session twice a week for three weeks

Group Type ACTIVE_COMPARATOR

Acupuncture

Intervention Type PROCEDURE

The first set consists of core point selection, used in an MS Standard of Care (SOC). The second set of points will be individualized to the patient's needs as determined by the acupuncturist. SOC treatment will be based upon Traditional Chinese Medicine (TCM) interpretation of 4 phases of MS.

Interventions

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Standard of Care with no acupuncture

The control group will lie on a treatment table in the acupuncturist's office for the same amount of time that the treatment group did, but receive no acupuncture

Intervention Type PROCEDURE

Acupuncture

The first set consists of core point selection, used in an MS Standard of Care (SOC). The second set of points will be individualized to the patient's needs as determined by the acupuncturist. SOC treatment will be based upon Traditional Chinese Medicine (TCM) interpretation of 4 phases of MS.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* diagnosis of MS
* ability to walk unaided for 6 minutes with or without assistive device

Exclusion Criteria

* bleeding precautions
* trypanophobia
* inability to lie still for 30 minutes
* active cancer, current exacerbation, and history of previous acupuncture treatment
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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NYU Langone Health

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Barbara Siminovich-blok

Role: PRINCIPAL_INVESTIGATOR

NYU Langone Health

Locations

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New York University School of Medicine

New York, New York, United States

Site Status

Countries

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United States

Other Identifiers

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15-00440

Identifier Type: -

Identifier Source: org_study_id

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