Dry Needling in Multiple Sclerosis

NCT ID: NCT06394310

Last Updated: 2025-06-11

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-01
• Study Completion Date: 2025-08-01

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 Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Dry needling

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

Group Type: EXPERIMENTAL

Dry needling

Intervention Type: DEVICE

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

Sham DN

Participants randomized to the control group will be receiving sham needling

Group Type: SHAM_COMPARATOR

Sham dry needling

Intervention Type: DEVICE

In the control group, The investigators will use the methods proposed by Cushman et al. to apply sham dry needling (DN) to our participants

Interventions

Dry needling

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

Intervention Type: DEVICE

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

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Kansas Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Jacob J. Sosnoff, Ph.D.

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Mobility and Falls Lab

Kansas City, Kansas, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Abbas TABATABAEI, PhD

Role: CONTACT

stabatabaeihalavi@kumc.edu

913-588-3715

Facility Contacts

Amir Tabatabaei Dr Tabatabaei, PhD

Role: primary

stabatabaeihalavi@kumc.edu

9135885000

Other Identifiers

STUDY00151015

Identifier Type: -

Identifier Source: org_study_id