Dry Needling in Multiple Sclerosis

Multiple Sclerosis Clinical Trial

Official title:

The Effectiveness of Dry Needling on Reducing Spasticity and Promoting Mobility and Balance in People With Multiple Sclerosis

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06394310
• Other study ID #: STUDY00151015
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 1, 2024
• Est. completion date: June 1, 2025

Study information

• Verified date: April 2024
• Source: University of Kansas Medical Center
• Contact: Abbas TABATABAEI, PhD
• Phone: 913-588-3715
• Email: stabatabaeihalavi[@]kumc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 24
• Est. completion date: June 1, 2025
• Est. primary completion date: May 2, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

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.

Related Conditions & MeSH terms

• Multiple Sclerosis
• Muscle Spasticity
• Sclerosis
• Spasticity

Intervention

Device:
• 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

Locations

Country	Name	City	State
United States	Human Performance lab	Kansas City	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
University of Kansas Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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