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

Multiple Sclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03174379
• Other study ID #: 15-00440
• Status: Completed
• Phase: N/A
• Start date: June 5, 2017
• Est. completion date: June 6, 2019

Study information

• Verified date: March 2022
• Source: NYU Langone Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: June 6, 2019
• Est. primary completion date: June 6, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Procedure:
• 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
• 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.

Locations

Country	Name	City	State
United States	New York University School of Medicine	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
NYU Langone Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Gait measured by 6-minute walk test	Assesses distance walked over 6 minutes as a sub-maximal test of aerobic capacity/endurance	14 Weeks
Primary	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