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

Not Applicable

Completed

• Conditions: Multiple Sclerosis
• Interventions: Procedure: Standard of Care with no acupuncture; Procedure: Acupuncture

• Registration Number: NCT03174379
• Lead Sponsor: NYU Langone Health

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2017-05-31
• Study First Submitted QC: 2017-06-01
• Study First Posted: 2017-06-02
• Study Start: 2017-06-05
• Primary Completion: 2019-06-06
• Study Completion: 2019-06-06
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-07
• Last Update Posted: 2022-03-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Group	Standard of Care with no acupuncture	Standard of Care (SOC) treatment will be based upon Traditional Chinese Medicine (TCM) interpretation of 4 phases of MS.
Treatment Group	Acupuncture	60-minute treatment session twice a week for three weeks

Primary Outcome Measures

Name	Time	Method
Gait measured by 6-minute walk test	14 Weeks	Assesses distance walked over 6 minutes as a sub-maximal test of aerobic capacity/endurance
Balance measured by 25-foot walk test	14 Weeks	The T25-FW is a quantitative mobility and leg function performance test based on a timed 25-walk.
fatigue severity scale	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.
Medical Outcomes Study Pain Effects Scale	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

Trial Locations

Locations (1)

New York University School of Medicine; 🇺🇸 New York, New York, United States