## Protocol Section
### Identification Module
**NCT ID:** 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

#### Organization Study ID Info
**ID:** 15-00440
#### Organization
**Class:** OTHER
**Full Name:** NYU Langone Health
### Status Module
#### Completion Date
**Date:** 2019-06-06

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2022-03-21

**Type:** ACTUAL

**Last Update Submit Date:** 2022-03-07

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2019-06-06

**Type:** ACTUAL

#### Start Date
**Date:** 2017-06-05

**Type:** ACTUAL

**Status Verified Date:** 2022-03

#### Study First Post Date
**Date:** 2017-06-02
**Type:** ACTUAL
**Study First Submit Date:** 2017-05-31
**Study First Submit QC Date:** 2017-06-01
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** NYU Langone Health

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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.

### Conditions Module

**Conditions:**

- Multiple Sclerosis

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** SINGLE

**Who Masked:**

- PARTICIPANT

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 13

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Standard of Care (SOC) treatment will be based upon Traditional Chinese Medicine (TCM) interpretation of 4 phases of MS.

**Intervention Names:**

- Procedure: Standard of Care with no acupuncture

**Label:** Control Group

**Type:** PLACEBO_COMPARATOR

#### Arm Group 2

**Description:** 60-minute treatment session twice a week for three weeks

**Intervention Names:**

- Procedure: Acupuncture

**Label:** Treatment Group

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Control Group

**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

**Name:** Standard of Care with no acupuncture

**Type:** PROCEDURE

#### Intervention 2

**Arm Group Labels:**

- Treatment Group

**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.

**Name:** Acupuncture

**Type:** PROCEDURE

### Outcomes Module

#### Primary Outcomes

**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.

**Measure:** fatigue severity scale

**Time Frame:** 14 Weeks

**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

**Measure:** Medical Outcomes Study Pain Effects Scale

**Time Frame:** 14 Weeks

**Description:** Assesses distance walked over 6 minutes as a sub-maximal test of aerobic capacity/endurance

**Measure:** Gait measured by 6-minute walk test

**Time Frame:** 14 Weeks

**Description:** The T25-FW is a quantitative mobility and leg function performance test based on a timed 25-walk.

**Measure:** Balance measured by 25-foot walk test

**Time Frame:** 14 Weeks

### Eligibility Module

**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

**Maximum Age:** 65 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** New York

**Country:** United States

**Facility:** New York University School of Medicine

**State:** New York

**Zip:** 10016

#### Overall Officials

**Official 1:**

**Affiliation:** NYU Langone Health

**Name:** Barbara Siminovich-blok

**Role:** PRINCIPAL_INVESTIGATOR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000010335

- Term: Pathologic Processes

- ID: D000020278

- Term: Demyelinating Autoimmune Diseases, CNS

- ID: D000020274

- Term: Autoimmune Diseases of the Nervous System

- ID: D000009422

- Term: Nervous System Diseases

- ID: D000003711

- Term: Demyelinating Diseases

- ID: D000001327

- Term: Autoimmune Diseases

- ID: D000007154

- Term: Immune System Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC10

- Name: Nervous System Diseases

- Abbrev: BC20

- Name: Immune System Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: BXM

- Name: Behaviors and Mental Disorders

### Condition Browse Module - Browse Leaves

- ID: M12060

- Name: Multiple Sclerosis

- Relevance: HIGH

- As Found: Multiple Sclerosis

- ID: M15415

- Name: Sclerosis

- Relevance: HIGH

- As Found: Sclerosis

- ID: M4629

- Name: Autoimmune Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M22098

- Name: Demyelinating Autoimmune Diseases, CNS

- Relevance: LOW

- As Found: Unknown

- ID: M22094

- Name: Autoimmune Diseases of the Nervous System

- Relevance: LOW

- As Found: Unknown

- ID: M6909

- Name: Demyelinating Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M10200

- Name: Immune System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: T6034

- Name: Quality of Life

- Relevance: HIGH

- As Found: Quality of Life

### Condition Browse Module - Meshes

- ID: D000009103

- Term: Multiple Sclerosis

- ID: D000012598

- Term: Sclerosis

### Misc Info Module

- Version Holder: 2024-05-24
