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Effectiveness of Dry Needling for Improving Gait in the Patient With Multiple Sclerosis (DRYNEEDEM)

Primary Purpose

Multiple Sclerosis

Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
dry needling + physiotherapy (standard/usual care)
sham dry needling + physiotherapy (standard/usual care)
Sponsored by
Hospital Universitario de Canarias
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Sclerosis

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Having been diagnosed with Multiple Sclerosis in a period of more than two years before the study starts Participate voluntarily and sign the informed consent. Suffering from some type of hypertonia or spasticity in MMII that makes walking difficult, measured with Expanded Disability Status Scale>2 (Pyramidal section >2) Age from 18 to 60 years old. Not having phobia of needles. Exclusion Criteria: Not signing the informed consent. Having a phobia of needles. Presenting an outbreak at the start of the study or having presented any outbreak up to two months before the start of the study.

Sites / Locations

  • Hospital Universitario de CanariasRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

dry needling

placebo

Arm Description

The intervention group will have a single session of dry nedling application in the medial gastrocnemius + usual care (physiotherapy)

The control group will have a single session of sham dry nedling in the medial gastrocnemius + usual care (physiotherapy)

Outcomes

Primary Outcome Measures

Change in Timed 25-Foot Walk (T25FW)
is a quantitative mobility and leg function performance test based on a timed 25-walk. This is considered the "gold standard" to assess gait speed in MS patients. The test measures the time in seconds that the patient needs to walk 25 feet (7.5 meters).

Secondary Outcome Measures

Change in Multiple Sclerosis Walking Scale (MSWS-12)
is a self-report measure of the impact of MS on the individual´s walking ability. Each item is scored from 1 (no limitation) to 5 (extreme limitation), with a total score ranging from 12 to 60, where higher values show higher impairment . MSWS-12 scale shows properties which make it suitable for use in clinical practice, concretely for patients with medium-to-high levels of walking disability
Change in The Time up and go test (TUG)
was designed initially to measure the probability for falls among older adults, but has been validated also for other populations such as MS. For this test, the participants sit in a chair with their backs supported by the back of the chair and their arms resting on the armrests. The participants are asked to get up from the chair and walk a distance of 3 me-ters, to turn on themselves (360°) and walk back to the chair and sit down again. The TUG test has demon-strated to be highly reliable and responsive in the assessment of respectively the walking capacity and general mobility of patients with MS with mild disability
Change in The Multiple Sclerosis International QoL (Musiqol-54)
This is a specific quality of life questionnaire for MS. This is a self-assessment question-naire composed of 54 items, divided in a physical and mental domain. The range goes from 0 to 100, where 100 is the highest degree of quality of life. The Spanish version of the MSQoL 54 instrument has shown to be a valid and reliable instrument for measuring qual-ity of life in patients with MS
Change in analog scale of quality of life
analog scale of quality of life from 0 to 10

Full Information

First Posted
July 11, 2023
Last Updated
August 10, 2023
Sponsor
Hospital Universitario de Canarias
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1. Study Identification

Unique Protocol Identification Number
NCT05956119
Brief Title
Effectiveness of Dry Needling for Improving Gait in the Patient With Multiple Sclerosis
Acronym
DRYNEEDEM
Official Title
Analysis of the Effectiveness of Dry Needling for Improving Gait in the Patient With Multiple Sclerosis: a Randomized Single-blind Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 3, 2023 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
March 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Universitario de Canarias

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
Multiple sclerosis (MS) is a chronic, inflammatory, autoimmune disease characterized by the appearance of lesions, characterized by heterogeneity in its pathological, clinical and radiological presentation. It has a significant socioeconomic impact, affecting interpersonal relationships and causing a significant reduction in quality of life. Patients with MS suffer from a series of symptoms (ocular, spasticity, cerebellar, sensory, fatigue, depression) that may be independent of the course of the disease and their management significantly influences quality of life and also requires multidisciplinary therapeutic measures. Physiotherapy and occupational therapy techniques are essential to reduce spasticity and prevent complications derived from it. Amongst physiotherapy techniques, we can find minimally invasive techniques such as dry needling which uses a fine filiform needle to penetrate the skin and mechanically break the myofascial trigger points, charactewrized by abnomral/pathological electrical activity. There have been previous studies with dry needling in stroke patients which have shown improvements in gait, but its effectiveness in other populations such as multiple sclerosis is still unclear. In addition, dry needling has proven to be a cost-effective treatment for spasticity in patients with chronic and subacute stroke and could be an alternative to other pharmacological treatments, although more studies are necessary to compare both the effectiveness and the cost-effectiveness . Recent studies carried out in patients with multiple sclerosis suggest that dry needling can improve mobility and gait speed. The main objective of the study is to analyze the effect of the application of a single session of dry needling in the lower limbs on the gait of patients with multiple sclerosis. A prospective randomized parallel group clinical trial with blinded outcome assessment will be conducted. Participants will be recruited from the Hospital Universitario de Canarias.

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
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
dry needling
Arm Type
Experimental
Arm Description
The intervention group will have a single session of dry nedling application in the medial gastrocnemius + usual care (physiotherapy)
Arm Title
placebo
Arm Type
Sham Comparator
Arm Description
The control group will have a single session of sham dry nedling in the medial gastrocnemius + usual care (physiotherapy)
Intervention Type
Device
Intervention Name(s)
dry needling + physiotherapy (standard/usual care)
Intervention Description
same that arm descrption
Intervention Type
Other
Intervention Name(s)
sham dry needling + physiotherapy (standard/usual care)
Intervention Description
same that arm description
Primary Outcome Measure Information:
Title
Change in Timed 25-Foot Walk (T25FW)
Description
is a quantitative mobility and leg function performance test based on a timed 25-walk. This is considered the "gold standard" to assess gait speed in MS patients. The test measures the time in seconds that the patient needs to walk 25 feet (7.5 meters).
Time Frame
inmediatly before intervention, inmediatly after intervention, a week after the intervention and a month after the intervention
Secondary Outcome Measure Information:
Title
Change in Multiple Sclerosis Walking Scale (MSWS-12)
Description
is a self-report measure of the impact of MS on the individual´s walking ability. Each item is scored from 1 (no limitation) to 5 (extreme limitation), with a total score ranging from 12 to 60, where higher values show higher impairment . MSWS-12 scale shows properties which make it suitable for use in clinical practice, concretely for patients with medium-to-high levels of walking disability
Time Frame
inmediatly before intervention, a week after the intervention and a month after the intervention
Title
Change in The Time up and go test (TUG)
Description
was designed initially to measure the probability for falls among older adults, but has been validated also for other populations such as MS. For this test, the participants sit in a chair with their backs supported by the back of the chair and their arms resting on the armrests. The participants are asked to get up from the chair and walk a distance of 3 me-ters, to turn on themselves (360°) and walk back to the chair and sit down again. The TUG test has demon-strated to be highly reliable and responsive in the assessment of respectively the walking capacity and general mobility of patients with MS with mild disability
Time Frame
inmediatly before intervention, inmediatly after intervention, a week after the intervention and a month after the intervention
Title
Change in The Multiple Sclerosis International QoL (Musiqol-54)
Description
This is a specific quality of life questionnaire for MS. This is a self-assessment question-naire composed of 54 items, divided in a physical and mental domain. The range goes from 0 to 100, where 100 is the highest degree of quality of life. The Spanish version of the MSQoL 54 instrument has shown to be a valid and reliable instrument for measuring qual-ity of life in patients with MS
Time Frame
inmediatly before intervention and a month after the intervention
Title
Change in analog scale of quality of life
Description
analog scale of quality of life from 0 to 10
Time Frame
inmediatly beforeintervention, a week after intervention and a month after intervention

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: Having been diagnosed with Multiple Sclerosis in a period of more than two years before the study starts Participate voluntarily and sign the informed consent. Suffering from some type of hypertonia or spasticity in MMII that makes walking difficult, measured with Expanded Disability Status Scale>2 (Pyramidal section >2) Age from 18 to 60 years old. Not having phobia of needles. Exclusion Criteria: Not signing the informed consent. Having a phobia of needles. Presenting an outbreak at the start of the study or having presented any outbreak up to two months before the start of the study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
ALBERTO JAVIER, PT, MSc
Phone
600367861
Email
albert.jaor@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ALBERTO JAVIER, PT, MSc
Organizational Affiliation
Hospital Universitario de Canarias
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Universitario de Canarias
City
La Laguna
State/Province
Santa Cruz De Tenerife
ZIP/Postal Code
38320
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
ALBERTO JAVIER ORMAZÁBAL, PT
Phone
600367861
Email
albert.jaor@gmail.com
First Name & Middle Initial & Last Name & Degree
CONSUELO RODRÍGUEZ GIMÉNEZ, PHD
Phone
922678573
Email
conrodjim@gmail.com
First Name & Middle Initial & Last Name & Degree
PILAR PÉREZ-TRUJILLO, PT, MSc
First Name & Middle Initial & Last Name & Degree
MONSERRAT GONZÁLEZ-PLATAS, MD, PHD
First Name & Middle Initial & Last Name & Degree
ALBERTO JAVIER-ORMAZÁBAL, PT, MSc
First Name & Middle Initial & Last Name & Degree
PABLO HERRERO, PT,PHD

12. IPD Sharing Statement

Learn more about this trial

Effectiveness of Dry Needling for Improving Gait in the Patient With Multiple Sclerosis

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