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Completed

NCT Number: NCT03174379

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

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.

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Nervous System Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

New York University School of Medicine

New York, 10016, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Standard of Care with no acupuncture

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

Acupuncture

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.

Primary outcomes

  1. fatigue severity scale

    Time frame: 14 Weeks

    The Fatigue Severity Scale (FSS) is a method of evaluating the impact of fatigue. The FSS is a short questionnaire that requires patient to rate level of fatigue.

  2. Medical Outcomes Study Pain Effects Scale

    Time frame: 14 Weeks

    The MOS covers pain severity in terms of intensity, frequency, and duration while recording the impact on behaviours and moods. MOS contains twelve self report items on the severity of pain over the past four weeks and its effect on mood and behaviours

  3. Gait measured by 6-minute walk test

    Time frame: 14 Weeks

    Assesses distance walked over 6 minutes as a sub-maximal test of aerobic capacity/endurance

  4. Balance measured by 25-foot walk test

    Time frame: 14 Weeks

    The T25-FW is a quantitative mobility and leg function performance test based on a timed 25-walk.

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Jun 2, 2017
Registry last updated
Mar 21, 2022

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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