Dry Needling in Multiple Sclerosis

NCT06394310 | Recruiting DMC

• 1 other identifier: STUDY00151015
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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

Keywords

multiple sclerosis; Dry needling; Spasticity; Mobility; Balance

Outcome Measures

Primary Outcomes (1)

• Spasticity

  Spasticity will be assessed through the Modified Ashworth scale (Scored between 0 to 4, with higher scores show higher level of spasticity)

  5 weeks

Study Arms (2)

Dry needling

EXPERIMENTAL

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

Device: Dry needling

Sham DN

SHAM COMPARATOR

Participants randomized to the control group will be receiving sham needling

Device: Sham dry needling

Interventions

Dry needling DEVICE

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

Dry needling

Sham dry needling 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

Sham DN

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Kansas Medical Center: lead

Study Sites (1)

Mobility and Falls Lab

Kansas City, Kansas, 66103, United States

RECRUITING

MeSH Terms

Conditions

Multiple Sclerosis; Muscle Spasticity

Interventions

Dry Needling

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Physical Therapy Modalities

Central Study Contacts

Abbas TABATABAEI, PhD

CONTACT

913-588-3715; stabatabaeihalavi@kumc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 26, 2024
• First Posted: May 1, 2024
• Study Start: May 1, 2024
• Primary Completion: July 2, 2025
• Study Completion: August 1, 2025
• Last Updated: June 11, 2025

Record last verified: 2025-06

Locations

US (1)