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

NCT ID: NCT05956119

Last Updated: 2023-11-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-03

Study Completion Date

2023-11-28

Brief Summary

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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.

Detailed Description

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Conditions

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Multiple Sclerosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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dry needling

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

Group Type EXPERIMENTAL

dry needling + physiotherapy (standard/usual care)

Intervention Type DEVICE

same that arm descrption

placebo

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

Group Type SHAM_COMPARATOR

sham dry needling + physiotherapy (standard/usual care)

Intervention Type OTHER

same that arm description

Interventions

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dry needling + physiotherapy (standard/usual care)

same that arm descrption

Intervention Type DEVICE

sham dry needling + physiotherapy (standard/usual care)

same that arm description

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. Having been diagnosed with Multiple Sclerosis in a period of more than two years before the study starts
2. Participate voluntarily and sign the informed consent.
3. Suffering from some type of hypertonia or spasticity in MMII that makes walking difficult, measured with Expanded Disability Status Scale\>2 (Pyramidal section \>2)
4. Age from 18 to 60 years old.
5. Not having phobia of needles.

Exclusion Criteria

1. Not signing the informed consent.
2. Having a phobia of needles.
3. Presenting an outbreak at the start of the study or having presented any outbreak up to two months before the start of the study.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital Universitario de Canarias

OTHER

Sponsor Role lead

Responsible Party

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Alberto Javier Ormazábal

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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ALBERTO JAVIER, PT, MSc

Role: PRINCIPAL_INVESTIGATOR

Hospital Universitario de Canarias

Locations

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Hospital Universitario de Canarias

San Cristóbal de La Laguna, Santa Cruz De Tenerife, Spain

Site Status

Countries

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Spain

Other Identifiers

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CHUC_2023_40

Identifier Type: -

Identifier Source: org_study_id