Dry Needling in Multiple Sclerosis

Not Applicable

Not yet recruiting

• Conditions: Spasticity; Multiple Sclerosis
• Interventions: Device: Sham dry needling; Device: Dry needling

• Registration Number: NCT06394310
• Lead Sponsor: University of Kansas Medical Center

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-04
• Study First Submitted: 2024-04-26
• Study First Submitted QC: 2024-04-30
• Last Update Submitted: 2024-04-30
• Study Start: 2024-05-01
• Study First Posted: 2024-05-01
• Last Update Posted: 2024-05-02
• Primary Completion: 2025-05-02
• Study Completion: 2025-06-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 24

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sham DN	Sham dry needling	Participants randomized to the control group will be receiving sham needling
Dry needling	Dry needling	Participants will complete three sessions of dry needling through three weeks (one session per each week)

Primary Outcome Measures

Name	Time	Method
Spasticity	5 weeks	Spasticity will be assessed through the Modified Ashworth scale (Scored between 0 to 4, with higher scores show higher level of spasticity)

Trial Locations

Locations (1)

Mobility and Falls Lab; 🇺🇸 Kansas City, Kansas, United States