Multiple SclerosisNCT06394310
Dry Needling in Multiple Sclerosis
A study testing Dry needling in people with Multiple Sclerosis and Spasticity, run by University of Kansas Medical Center at 1 site in United States.
Trial summary
The investigators are doing this study to see if a treatment called dry needling improves muscle spasticity (muscle tightness) in people who have Multiple Sclerosis. Dry needling involves using tiny needles, like those in acupuncture, to target some muscles, like calf muscles. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Multiple Sclerosis, Spasticity
- What is being tested?
- Dry needling
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2024to 1 Aug 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age 18 to 64 years
- Clinical diagnosis of Multiple Sclerosis based on the McDonald Criteria
- Spasticity in their lower legs
- Patient Determined Disease Steps (PDDS) score of 5 or below
Who cannot join
- Inability to communicate effectively with study personnel
- Needle phobia
- Severe varicose veins
- Presence of an active implanted device
- Pregnancy
- Any active cancer or history within 1 year
Show all 12Show fewer
- known or suspected infection at the site of needling or in the surrounding area
- Presence of a fixed plantarflexion contracture at the ankle
- Acute fracture of dislocation in the region (bilateral lower extremity)
- Deep vein thrombosis or peripheral vascular disease
- Thrombophlebitis, or active osteomyelitis in the region (bilateral lower extremity)
- Any medication changes, including antispastic medicines, for the past three months.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Mobility and Falls Lab
Kansas City, Kansas, 66103
Amir Tabatabaei Dr Tabatabaei, PhD, 9135885000, stabatabaeihalavi@kumc.edu
About this study
Official title: The Effectiveness of Dry Needling on Reducing Spasticity and Promoting Mobility and Balance in People With Multiple Sclerosis
The investigators are doing this study to see if a treatment called dry needling improves muscle spasticity (muscle tightness) in people who have Multiple Sclerosis. Dry needling involves using tiny needles, like those in acupuncture, to target some muscles, like calf muscles. It differs from traditional acupuncture as it focuses on treating or managing muscle spots, aiming to reduce muscle stiffness and pain. Dry needling may offer a minimally-invasive and medication-free approach to improve muscle spasticity. The investigators hope to see if dry needling also helps enhance balance and walking abilities. This might provide potential improvements inoverall mobility and balance.
- Conditions
- Multiple Sclerosis, Spasticity
- Being tested
- Dry needling, Sham dry needling
- Keywords
- multiple sclerosis, Dry needling, Spasticity, Mobility, Balance
- Medical subject headings
- Multiple Sclerosis, Muscle Spasticity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dry needlingDevice
The dry needling technique will employ in the current proposed study follows the standard technique for needling patients with spasticity
Sham dry needlingDevice
In the control group, The investigators will use the methods proposed by Cushman et al. to apply sham dry needling (DN) to our participants
| Study group | Role | What they receive |
|---|---|---|
| Dry needling | Experimental | Participants will complete three sessions of dry needling through three weeks (one session per each week) Receives: Device: Dry needling |
| Sham DN | Sham comparator | Participants randomized to the control group will be receiving sham needling Receives: Device: Sham dry needling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Spasticity
Spasticity will be assessed through the Modified Ashworth scale (Scored between 0 to 4, with higher scores show higher level of spasticity)
Measured: 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2024
- Study start1 May 2024
- Primary completion2 Jul 2025 (estimated)
- Study completion1 Aug 2025 (estimated)
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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Kansas Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jacob J. Sosnoff, Ph.D., University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06394310
- Sponsor's protocol ID
- STUDY00151015
- Status last verified
- Jun 2025
- First submitted
- 26 Apr 2024
- Last updated
- 11 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Dry Needling on Reducing Spasticity and Promoting Mobility and Balance in People With Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT06394310
- Acronym / sponsor ID
- STUDY00151015
- Conditions
- Multiple Sclerosis, Spasticity
- Keywords
- multiple sclerosis, Dry needling, Spasticity, Mobility, Balance
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- University of Kansas Medical CenterUniversity, hospital or other
- Study start
- 1 May 2024 (actual)
- Primary completion
- 2 Jul 2025 (estimated)
- Study completion
- 1 Aug 2025 (estimated)
- First posted
- 1 May 2024 (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 investigators are doing this study to see if a treatment called dry needling improves muscle spasticity (muscle tightness) in people who have Multiple Sclerosis. Dry needling involves using tiny needles, like those in acupuncture, to target some muscles, like calf muscles. It differs from traditional acupuncture as it focuses on treating or managing muscle spots, aiming to reduce muscle stiffness and pain. Dry needling may offer a minimally-invasive and medication-free approach to improve muscle spasticity. The investigators hope to see if dry needling also helps enhance balance and walking abilities. This might provide potential improvements inoverall mobility and balance.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dry needling | Experimental | Device: Dry needlingParticipants will complete three sessions of dry needling through three weeks (one session per each week) |
| Sham DN | Sham comparator | Device: Sham dry needlingParticipants randomized to the control group will be receiving sham needling |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age 18 to 64 years
- Clinical diagnosis of Multiple Sclerosis based on the McDonald Criteria
- Spasticity in their lower legs
- Patient Determined Disease Steps (PDDS) score of 5 or below
Key exclusion criteria (12 listed)
- Inability to communicate effectively with study personnel
- Needle phobia
- Severe varicose veins
- Presence of an active implanted device
- Pregnancy
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 needlingThe dry needling technique will employ in the current proposed study follows the standard technique for needling patients with spasticity | Device | Dry needling |
| Sham dry needlingIn the control group, The investigators will use the methods proposed by Cushman et al. to apply sham dry needling (DN) to our participants | Device | Sham DN |
Primary outcome
Spasticity
Time frame: 5 weeks
Spasticity will be assessed through the Modified Ashworth scale (Scored between 0 to 4, with higher scores show higher level of spasticity)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2025.
- Individual participant dataSharing planned: Undecided
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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.
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 and Spasticity, run by University of Kansas Medical Center at 1 site in United States.
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 4 inclusion and 12 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: looking for participants now, as of the sponsor's last update on 11 Jun 2025. 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 United States. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Abbas TABATABAEI, PhD (913-588-3715, stabatabaeihalavi@kumc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Spasticity (time frame: 5 weeks). 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 11 Jun 2025.