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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Multiple Sclerosis

Intervention / Treatment
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* Procedure: Standard of Care with no acupuncture
* Procedure: Acupuncture


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Control Group<br>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<br>* 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<br>|
| Active Comparator: Treatment Group<br>60-minute treatment session twice a week for three weeks | Procedure: Acupuncture<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |