- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06394310
Dry Needling in Multiple Sclerosis
June 5, 2025 updated by: Jacob J. Sosnoff, Ph.D., University of Kansas Medical Center
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
24
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Abbas TABATABAEI, PhD
- Phone Number: 913-588-3715
- Email: stabatabaeihalavi@kumc.edu
Study Locations
-
-
Kansas
-
Kansas city, Kansas, United States, 66103
- Recruiting
- Mobility and Falls Lab
-
Contact:
- Amir Tabatabaei Dr Tabatabaei, PhD
- Phone Number: 9135885000
- Email: stabatabaeihalavi@kumc.edu
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Dry needling
Participants will complete three sessions of dry needling through three weeks (one session per each week)
|
The dry needling technique will employ in the current proposed study follows the standard technique for needling patients with spasticity
|
|
Sham Comparator: Sham DN
Participants randomized to the control group will be receiving sham needling
|
In the control group, The investigators will use the methods proposed by Cushman et al. to apply sham dry needling (DN) to our participants
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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)
|
5 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 1, 2024
Primary Completion (Estimated)
July 2, 2025
Study Completion (Estimated)
August 1, 2025
Study Registration Dates
First Submitted
April 26, 2024
First Submitted That Met QC Criteria
April 30, 2024
First Posted (Actual)
May 1, 2024
Study Record Updates
Last Update Posted (Actual)
June 11, 2025
Last Update Submitted That Met QC Criteria
June 5, 2025
Last Verified
June 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neurologic Manifestations
- Musculoskeletal Diseases
- Nervous System Diseases
- Muscular Diseases
- Muscle Hypertonia
- Neuromuscular Manifestations
- Pathologic Processes
- Autoimmune Diseases
- Immune System Diseases
- Demyelinating Autoimmune Diseases, CNS
- Autoimmune Diseases of the Nervous System
- Demyelinating Diseases
- Muscle Spasticity
- Multiple Sclerosis
- Sclerosis
Other Study ID Numbers
- STUDY00151015
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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