A Study to Analyze the Effect of Acupuncture on Mobility And Quality of Life in Multiple Sclerosis
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|ClinicalTrials.gov Identifier: NCT03174379|
Recruitment Status : Recruiting
First Posted : June 2, 2017
Last Update Posted : November 19, 2019
|Condition or disease||Intervention/treatment||Phase|
|Multiple Sclerosis||Procedure: Standard of Care with no acupuncture Procedure: Acupuncture||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|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|
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
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.
- 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.
- 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
- 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
- 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.
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
|Contact: olanta chandler||212 263 firstname.lastname@example.org|
|United States, New York|
|New York University School of Medicine||Recruiting|
|New York, New York, United States, 10016|
|Contact: Olanta Chandler 212-263-0844 email@example.com|
|Principal Investigator: Barbara Siminovich-blok, MD|
|Principal Investigator:||Barbara Siminovich-blok||NYU Langone Health|