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

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

Study Locations

    • Kansas
      • Kansas city, Kansas, United States, 66103
        • Recruiting
        • Mobility and Falls Lab
        • Contact:

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

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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