Multiple SclerosisNCT05351957
Dry Needling for Treating Spasticity in Multiple Sclerosis
A study testing Dry needling in people with Multiple Sclerosis, run by Hospital Universitario de Canarias at 1 site in Spain.
Trial summary
The aim of the study is to evaluate the efficacy of dry needling (DN) in the treatment of spasticity in patients with multiple sclerosis (MS). [Participants and Methods] participants with MS, with no evidence of a relapse in the last four weeks and with an EDSS (Expanded Disability Sta- tus Scale) greater than 2.5… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Dry needling
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteSpain
- Study dates
- 18 Feb 2018to 22 Sep 2020
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Being a patient diagnosed with multiple sclerosis.
- Being over 18 years of age and less than or equal to 60 years of age.
- Having a score equal to or greater than 2 in the EDSS.
- They need to have a measurement in the following functional systems: P (pyramidal) >2, CT (brainstem), gait >2 and sphincter >2.
- They need to present hypertonia or contractures of the muscles selected for the dry needling, the pain expressed by the patients must be a consequence of spastic processes, have hourly availability to receive therapies and not have needle phobias.
Who cannot join
- Having a disease associated with multiple sclerosis that is incompatible with dry needling.
- Being in relapse, or having suffered it in the thirty days prior to starting the treatment. program or taking medications that are contraindicated with the technique applied in the study, (oral anticoagulants.)
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
The aim of the study is to evaluate the efficacy of dry needling (DN) in the treatment of spasticity in patients with multiple sclerosis (MS). [Participants and Methods] participants with MS, with no evidence of a relapse in the last four weeks and with an EDSS (Expanded Disability Sta- tus Scale) greater than 2.5 points (related with pyramidal score) were recruited. DN was performed in lower limbs for 12 consecutive sessions and evaluated with: EDSS (Pyramidal item), Time up and go (TUG), 25 foot, 9hold peg test (9HPT) and the improvement or not in the quality of life (MSQol54) was verified before and after treatment. A follow up visit was carried out to assess improvement.
- Conditions
- Multiple Sclerosis
- Being tested
- Dry needling
- Keywords
- Dry needling, multiple sclerosis, physiotherapy
- 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 needlingProcedure or surgery
Only dry needling of the lower limbs will performed in all patients with acupunture needling
| Study group | Role | What they receive |
|---|---|---|
| dry needling | Experimental | This study has only 1 arm and the control group is their baseline data Receives: Procedure: Dry needling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in 9HOLD PEG TEST score
This consists of placing the pegs in the corresponding holes of the 9 holes in the table in the shortest possible time (seconds)
Measured: inmediatly before and inmediatly after intervention
Change in 25 foot walk score
patients must walk a distance of 7.25 meters at the fastest and safest speed for them (seconds)
Measured: inmediatly before and inmediatly after intervention
Change in Time up and go test score
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 meters, then the patients turn on themselves (360°), walk back to the chair and sit down again (seconds)
Measured: inmediatly before and inmediatly after intervention
Change in Expanded Disability Status Scale (EDSS) score
Each item is valued individually and a score is given, which will then outline the patient's total EDSS ranging from 0 to 10, for use in the exploration sessions. All scans were carried out by a blind explorer.
Measured: inmediatly before and inmediatly after intervention
Change in Multiple sclerosis Quality of life-54 (MSQol54) score
questionnaire of 54 items measuring the quality of life of the patient. It can be self-administered or hetero-administered and both physical and mental aspects are measured. Within these there are subscales: among them quality of life in general. Two summary scores, physical health and mental health, can be derived from a weighted combination of scale scores. They range from 0 to 100, where 100 is the highest quality of life (both for physical and mental health)
Measured: inmediatly before and inmediatly after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2022
- Study start18 Feb 2018
- Primary completion20 Apr 2020
- Study completion22 Sep 2020
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 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
- MONSERRAT GONZÁLEZ-PLATAS, Study director, Hospital Universitario de Canarias
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05351957
- Sponsor's protocol ID
- 2017_100
- Status last verified
- Apr 2022
- First submitted
- 21 Apr 2022
- Last updated
- 28 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dry Needling for Treating Spasticity in Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT05351957
- Acronym / sponsor ID
- 2017_100
- Conditions
- Multiple Sclerosis
- Keywords
- Dry needling, multiple sclerosis, physiotherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Hospital Universitario de CanariasUniversity, hospital or other
- Study start
- 18 Feb 2018 (actual)
- Primary completion
- 20 Apr 2020 (actual)
- Study completion
- 22 Sep 2020 (actual)
- First posted
- 28 Apr 2022 (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.
The aim of the study is to evaluate the efficacy of dry needling (DN) in the treatment of spasticity in patients with multiple sclerosis (MS). [Participants and Methods] participants with MS, with no evidence of a relapse in the last four weeks and with an EDSS (Expanded Disability Sta- tus Scale) greater than 2.5 points (related with pyramidal score) were recruited. DN was performed in lower limbs for 12 consecutive sessions and evaluated with: EDSS (Pyramidal item), Time up and go (TUG), 25 foot, 9hold peg test (9HPT) and the improvement or not in the quality of life (MSQol54) was verified before and after treatment. A follow up visit was carried out to assess improvement.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| dry needling | Experimental | Procedure: Dry needlingThis study has only 1 arm and the control group is their baseline data |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Being a patient diagnosed with multiple sclerosis.
- Being over 18 years of age and less than or equal to 60 years of age.
- Having a score equal to or greater than 2 in the EDSS.
- They need to have a measurement in the following functional systems: P (pyramidal) >2, CT (brainstem), gait >2 and sphincter >2.
- They need to present hypertonia or contractures of the muscles selected for the dry needling, the pain expressed by the patients must be a consequence of spastic processes, have hourly availability to receive therapies and not have needle phobias.
Key exclusion criteria (2 listed)
- Having a disease associated with multiple sclerosis that is incompatible with dry needling.
- Being in relapse, or having suffered it in the thirty days prior to starting the treatment. program or taking medications that are contraindicated with the technique applied in the study, (oral anticoagulants.)
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 needlingOnly dry needling of the lower limbs will performed in all patients with acupunture needling | Procedure or surgery | dry needling |
Primary outcome
Change in 9HOLD PEG TEST score
Time frame: inmediatly before and inmediatly after intervention
This consists of placing the pegs in the corresponding holes of the 9 holes in the table in the shortest possible time (seconds)
Change in 25 foot walk score
Time frame: inmediatly before and inmediatly after intervention
patients must walk a distance of 7.25 meters at the fastest and safest speed for them (seconds)
Change in Time up and go test score
Time frame: inmediatly before and inmediatly after intervention
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 meters, then the patients turn on themselves (360°), walk back to the chair and sit down again (seconds)
Change in Expanded Disability Status Scale (EDSS) score
Time frame: inmediatly before and inmediatly after intervention
Each item is valued individually and a score is given, which will then outline the patient's total EDSS ranging from 0 to 10, for use in the exploration sessions. All scans were carried out by a blind explorer.
Change in Multiple sclerosis Quality of life-54 (MSQol54) score
Time frame: inmediatly before and inmediatly after intervention
questionnaire of 54 items measuring the quality of life of the patient. It can be self-administered or hetero-administered and both physical and mental aspects are measured. Within these there are subscales: among them quality of life in general. Two summary scores, physical health and mental health, can be derived from a weighted combination of scale scores. They range from 0 to 100, where 100 is the highest quality of life (both for physical and mental health)
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 28 Apr 2022.
- Individual participant dataSharing planned: No
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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.
MONSERRAT GONZÁLEZ-PLATAS study director
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 testing Dry needling in people with 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 2 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 28 Apr 2022. 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. 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 9HOLD PEG TEST score (time frame: inmediatly before and inmediatly after intervention). The study lists 5 primary outcomes in all. 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 28 Apr 2022.