Back to resultsA Study to Analyze the Effect of Acupuncture on Mobility And Quality of Life in Multiple Sclerosis
Primary Purpose
Multiple Sclerosis
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Standard of Care with no acupuncture
Acupuncture
Sponsored by
About this trial
This is an interventional treatment trial for Multiple Sclerosis
Eligibility Criteria
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
Sites / Locations
- New York University School of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
Control Group
Treatment Group
Arm Description
Standard of Care (SOC) treatment will be based upon Traditional Chinese Medicine (TCM) interpretation of 4 phases of MS.
60-minute treatment session twice a week for three weeks
Outcomes
Primary Outcome Measures
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.
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
Gait measured by 6-minute walk test
Assesses distance walked over 6 minutes as a sub-maximal test of aerobic capacity/endurance
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03174379
Brief Title
A Study to Analyze the Effect of Acupuncture on Mobility And Quality of Life in Multiple Sclerosis
Official Title
A Pilot Study to Analyze the Effect of Acupuncture on Mobility And Quality of Life in Multiple Sclerosis
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
June 5, 2017 (Actual)
Primary Completion Date
June 6, 2019 (Actual)
Study Completion Date
June 6, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
13 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control Group
Arm Type
Placebo Comparator
Arm Description
Standard of Care (SOC) treatment will be based upon Traditional Chinese Medicine (TCM) interpretation of 4 phases of MS.
Arm Title
Treatment Group
Arm Type
Active Comparator
Arm Description
60-minute treatment session twice a week for three weeks
Intervention Type
Procedure
Intervention Name(s)
Standard of Care with no acupuncture
Intervention Description
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
Intervention Name(s)
Acupuncture
Intervention Description
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 Outcome Measure Information:
Title
fatigue severity scale
Description
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.
Time Frame
14 Weeks
Title
Medical Outcomes Study Pain Effects Scale
Description
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
Time Frame
14 Weeks
Title
Gait measured by 6-minute walk test
Description
Assesses distance walked over 6 minutes as a sub-maximal test of aerobic capacity/endurance
Time Frame
14 Weeks
Title
Balance measured by 25-foot walk test
Description
The T25-FW is a quantitative mobility and leg function performance test based on a timed 25-walk.
Time Frame
14 Weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Barbara Siminovich-blok
Organizational Affiliation
NYU Langone Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York University School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Study to Analyze the Effect of Acupuncture on Mobility And Quality of Life in Multiple Sclerosis
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