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NCT Number: NCT05956119

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

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.

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Nervous System Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Universitario de Canarias

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

dry needling + physiotherapy (standard/usual care)

Device

same that arm descrption

sham dry needling + physiotherapy (standard/usual care)

Other

same that arm description

Primary outcomes

  1. Change in Timed 25-Foot Walk (T25FW)

    Time frame: inmediatly before intervention, inmediatly after intervention, a week after the intervention and a month after the intervention

    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 outcomes

  1. Change in Multiple Sclerosis Walking Scale (MSWS-12)

    Time frame: inmediatly before intervention, a week after the intervention and a month after the intervention

    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

  2. Change in The Time up and go test (TUG)

    Time frame: inmediatly before intervention, inmediatly after intervention, a week after the intervention and a month after the intervention

    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

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

    Time frame: inmediatly before intervention and a month after the intervention

    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

  4. Change in analog scale of quality of life

    Time frame: inmediatly beforeintervention, a week after intervention and a month after intervention

    analog scale of quality of life from 0 to 10

Sponsors and collaborators

Lead sponsor

Hospital Universitario de Canarias

Other

Registry information

Official study title

Analysis of the Effectiveness of Dry Needling for Improving Gait in the Patient With Multiple Sclerosis: a Randomized Single-blind Clinical Trial

Acronym: DRYNEEDEM

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jul 21, 2023
Registry last updated
Nov 29, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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