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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03174379
Recruitment Status : Recruiting
First Posted : June 2, 2017
Last Update Posted : November 19, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Multiple Sclerosis Procedure: Standard of Care with no acupuncture Procedure: Acupuncture Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: A Pilot Study to Analyze the Effect of Acupuncture on Mobility And Quality of Life in Multiple Sclerosis
Actual Study Start Date : June 5, 2017
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : July 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Control Group
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
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

Active Comparator: Treatment Group
60-minute treatment session twice a week for three weeks
Procedure: 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.




Primary Outcome Measures :
  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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03174379


Contacts
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Contact: olanta chandler 212 263 0844 olanta.chandler@nyumc.org

Locations
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United States, New York
New York University School of Medicine Recruiting
New York, New York, United States, 10016
Contact: Olanta Chandler    212-263-0844    olanta.chandler@nyumc.org   
Principal Investigator: Barbara Siminovich-blok, MD         
Sponsors and Collaborators
NYU Langone Health
Investigators
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Principal Investigator: Barbara Siminovich-blok NYU Langone Health
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Responsible Party: NYU Langone Health
ClinicalTrials.gov Identifier: NCT03174379    
Other Study ID Numbers: 15-00440
First Posted: June 2, 2017    Key Record Dates
Last Update Posted: November 19, 2019
Last Verified: November 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Multiple Sclerosis
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases