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

NCT03174379 | Completed

• 1 other identifier: 15-00440
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis

Outcome Measures

Primary Outcomes (4)

• fatigue severity scale

  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.

  14 Weeks

• Medical Outcomes Study Pain Effects Scale

  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

  14 Weeks

• Gait measured by 6-minute walk test

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

  14 Weeks

• Balance measured by 25-foot walk test

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

  14 Weeks

Study Arms (2)

Control Group

PLACEBO COMPARATOR

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

Procedure: Standard of Care with no acupuncture

Treatment Group

ACTIVE COMPARATOR

60-minute treatment session twice a week for three weeks

Procedure: Acupuncture

Interventions

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

Control Group

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.

Treatment Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

New York University School of Medicine

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Standard of Care; Acupuncture Therapy

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Complementary Therapies; Therapeutics

Study Officials

• Barbara Siminovich-blok

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 31, 2017
• First Posted: June 2, 2017
• Study Start: June 5, 2017
• Primary Completion: June 6, 2019
• Study Completion: June 6, 2019
• Last Updated: March 21, 2022

Record last verified: 2022-03

Locations

US (1)