Clinical trial NCT05956119: Effectiveness of Dry Needling for Improving Gait in the Patient With Multiple Sclerosis
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
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis
Lead sponsor: Hospital Universitario de Canarias
Sponsor class: OTHER
First posted: 2023-07-21
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change in Timed 25-Foot Walk (T25FW)
timeFrame: inmediatly before intervention, inmediatly after intervention, a week after the intervention and a month after the intervention
Secondary outcomes:
measure: Change in Multiple Sclerosis Walking Scale (MSWS-12)
timeFrame: inmediatly before intervention, a week after the intervention and a month after the intervention
measure: Change in The Time up and go test (TUG)
timeFrame: inmediatly before intervention, inmediatly after intervention, a week after the intervention and a month after the intervention
measure: Change in The Multiple Sclerosis International QoL (Musiqol-54)
timeFrame: inmediatly before intervention and a month after the intervention
measure: Change in analog scale of quality of life
timeFrame: inmediatly beforeintervention, a week after intervention and a month after intervention
Other outcomes:
Locations:
city: La Laguna
country: Spain
facility: Hospital Universitario de Canarias
state: Santa Cruz De Tenerife
Study officials:
affiliation: Hospital Universitario de Canarias
name: ALBERTO JAVIER, PT, MSc
role: PRINCIPAL_INVESTIGATOR
References: