Multiple SclerosisDRYNEEDEMNCT05956119
Effectiveness of Dry Needling for Improving Gait in the Patient With Multiple Sclerosis
A study of Multiple Sclerosis, run by Hospital Universitario de Canarias at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Multiple Sclerosis
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 1 siteSpain
- Study dates
- 3 Jul 2023to 28 Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Hospital Universitario de Canarias
San Cristóbal de La Laguna, Santa Cruz De Tenerife, 38320
About this study
Official title: Analysis of the Effectiveness of Dry Needling for Improving Gait in the Patient With Multiple Sclerosis: a Randomized Single-blind Clinical Trial
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.
Read more
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
- Being tested
- dry needling + physiotherapy (standard/usual care), sham dry needling + physiotherapy (standard/usual care)
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dry needling + physiotherapy (standard/usual care)Device
same that arm descrption
sham dry needling + physiotherapy (standard/usual care)Other
same that arm description
| Study group | Role | What they receive |
|---|---|---|
| dry needling | Experimental | The intervention group will have a single session of dry nedling application in the medial gastrocnemius + usual care (physiotherapy) Receives: 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) Receives: Other: sham dry needling + physiotherapy (standard/usual care) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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)
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
Measured: inmediatly before intervention, a week after the intervention and a month after the intervention
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
Measured: 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)
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
Measured: inmediatly before intervention and a month after the intervention
Change in analog scale of quality of life
analog scale of quality of life from 0 to 10
Measured: inmediatly beforeintervention, a week after intervention and a month after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2023
- Study start3 Jul 2023
- Primary completion2 Nov 2023
- Study completion28 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario de Canarias
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alberto Javier Ormazábal, Hospital Universitario de Canarias
- Investigators
- ALBERTO JAVIER, PT, MSc, Principal investigator, Hospital Universitario de Canarias
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05956119
- Sponsor's protocol ID
- CHUC_2023_40
- Acronym
- DRYNEEDEM
- Status last verified
- Nov 2023
- First submitted
- 11 Jul 2023
- Last updated
- 29 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of the Effectiveness of Dry Needling for Improving Gait in the Patient With Multiple Sclerosis: a Randomized Single-blind Clinical Trial
- ClinicalTrials.gov ID
- NCT05956119
- Acronym / sponsor ID
- DRYNEEDEM / CHUC_2023_40
- Conditions
- Multiple Sclerosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Hospital Universitario de CanariasUniversity, hospital or other
- Study start
- 3 Jul 2023 (actual)
- Primary completion
- 2 Nov 2023 (actual)
- Study completion
- 28 Nov 2023 (actual)
- First posted
- 21 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| dry needling | Experimental | Device: dry needling + physiotherapy (standard/usual care)The intervention group will have a single session of dry nedling application in the medial gastrocnemius + usual care (physiotherapy) |
| placebo | Sham comparator | Other: sham dry needling + physiotherapy (standard/usual care)The control group will have a single session of sham dry nedling in the medial gastrocnemius + usual care (physiotherapy) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| dry needling + physiotherapy (standard/usual care)same that arm descrption | Device | dry needling |
| sham dry needling + physiotherapy (standard/usual care)same that arm description | Other | placebo |
Primary outcome
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).
4 secondary outcomes
Change in Multiple Sclerosis Walking Scale (MSWS-12)
Time frame: inmediatly before intervention, a week after the intervention and a month after the intervention
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
Change in The Multiple Sclerosis International QoL (Musiqol-54)
Time frame: inmediatly before intervention and a month after the intervention
Change in analog scale of quality of life
Time frame: inmediatly beforeintervention, a week after intervention and a month after intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ALBERTO JAVIER, PT, MSc principal investigator
Hospital Universitario de Canarias
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Multiple Sclerosis, run by Hospital Universitario de Canarias at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2023.