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Clinical Trials/NCT06394310
NCT06394310RecruitingNot Applicable

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

University of Kansas Medical Center1 site in 1 country24 target enrollmentStarted: May 1, 2024Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
24
Locations
1
Primary Endpoint
Spasticity

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Participant, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 64 Years (Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Arms & Interventions

Dry needling

Experimental

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

Intervention: Dry needling (Device)

Sham DN

Sham Comparator

Participants randomized to the control group will be receiving sham needling

Intervention: Sham dry needling (Device)

Outcomes

Primary Outcomes

Spasticity

Time Frame: 5 weeks

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

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Jacob J. Sosnoff, Ph.D.

Principal Investigator

University of Kansas Medical Center

Study Sites (1)

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