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

NCT05956119 | Completed

• 1 other identifier: CHUC_2023_40
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis

Outcome Measures

Primary Outcomes (1)

• 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).

  inmediatly before intervention, inmediatly after intervention, a week after the intervention and a month after the intervention

Secondary Outcomes (4)

• Change in Multiple Sclerosis Walking Scale (MSWS-12)

  inmediatly before intervention, a week after the intervention and a month after the intervention

• Change in The Time up and go test (TUG)

  inmediatly before intervention, inmediatly after intervention, a week after the intervention and a month after the intervention

• Change in The Multiple Sclerosis International QoL (Musiqol-54)

  inmediatly before intervention and a month after the intervention

• Change in analog scale of quality of life

  inmediatly beforeintervention, a week after intervention and a month after intervention

Study Arms (2)

dry needling

EXPERIMENTAL

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

Device: dry needling + physiotherapy (standard/usual care)

placebo

SHAM COMPARATOR

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

Other: sham dry needling + physiotherapy (standard/usual care)

Interventions

dry needling + physiotherapy (standard/usual care) DEVICE

same that arm descrption

dry needling

sham dry needling + physiotherapy (standard/usual care) OTHER

same that arm description

placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital Universitario de Canarias: lead

Study Sites (1)

Hospital Universitario de Canarias

San Cristóbal de La Laguna, Santa Cruz De Tenerife, 38320, Spain

Location

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Dry Needling; Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Rehabilitation

Study Officials

• ALBERTO JAVIER, PT, MSc

  Hospital Universitario de Canarias

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 11, 2023
• First Posted: July 21, 2023
• Study Start: July 3, 2023
• Primary Completion: November 2, 2023
• Study Completion: November 28, 2023
• Last Updated: November 29, 2023

Record last verified: 2023-11

Locations

ES (1)