Recruiting

Dry Needling

Sponsor:

University of Kansas Medical Center

Code:

NCT06394310

Conditions

Multiple Sclerosis

Spasticity

Eligibility Criteria

Sex: All

Age: 18 - 64

Healthy Volunteers: Not accepted

Interventions

Dry needling

Sham dry needling

Study Details

Brief 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. 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

Study ID

NCT06394310

Start date

May 1, 2024

Status verified date

Jun, 2025

Completion date

Aug 1, 2025

Anticipated

Primary completion date

Jul 2, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 64

Healthy Volunteers: Not accepted

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 Design

Enrollment

24 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Dry needling

Participants will complete three sessions of dry needling through three weeks (one session per each week)

sham comparator: Sham DN

Participants randomized to the control group will be receiving sham needling

Interventions

Dry needling

The dry needling technique will employ in the current proposed study follows the standard technique for needling patients with spasticity

Sham dry 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

Primary outcome measure

  • Spasticity [ Time Frame: 5 weeks ]

Central Contacts and Locations

Central contacts

Locations

Mobility and Falls Lab

Recruiting

Kansas City, Kansas, United States, 66103

Contacts

Amir Tabatabaei Dr Tabatabaei, PhD

9135885000stabatabaeihalavi@kumc.edu

More Information

Sponsor

University of Kansas Medical Center

Last update posted

Jun 11, 2025

Last verified

Jun, 2025

Keywords

  • multiple sclerosis
  • Dry needling
  • Spasticity
  • Mobility
  • Balance

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Kansas Medical Center on 2025-06-11.