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Procedure

Dry Needling for Stroke (CDN Trial)

N/A

Waitlist Available

Led By Gretchen Seif, DPT

Research Sponsored by Medical University of South Carolina

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 7 days prior (2 time points), 6 days prior, 4 days prior, baseline, immediately after ddn, 90 minutes after ddn, 24 hours after, and 72 hours after ddn

Awards & highlights

No Placebo-Only Group

Summary

This trial is examining the effects of dry needling on spasticity in people with chronic stroke.

Eligible Conditions

Stroke
Spasticity

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 7 days prior (2 time points), 6 days prior, 4 days prior, baseline, immediately after ddn, 90 minutes after ddn, 24 hours after ddn, and 72 hours after ddn

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~7 days prior (2 time points), 6 days prior, 4 days prior, baseline, immediately after ddn, 90 minutes after ddn, 24 hours after ddn, and 72 hours after ddn

This trial's timeline: 3 weeks for screening, Varies for treatment, and 7 days prior (2 time points), 6 days prior, 4 days prior, baseline, immediately after ddn, 90 minutes after ddn, 24 hours after ddn, and 72 hours after ddn for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Changes in cutaneous reflexes elicited by non-noxious stimulation of cutaneous or mix nerves

Changes in perception of cutaneous stimuli as measured by perception and radiating threshold of cutaneous nerve stimulation

H-Reflex

Secondary study objectives

Change in ability to move the leg as measured by the Fugl-Meyer Assessment (FMA)

Pain

Change in spasticity as measured by the Modified Ashworth Scale (mAS)

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Dry Needling Reflex MeasurementsExperimental Treatment1 Intervention

All participants who participated in baseline reflex measurements during week 1 will continue to the second week of the study (Visits 5-7). Participants will receive dry needling to relieve spasticity in the target calf muscle (middle gastrocnemius) during Visit 5. The study team will examine the effects of this treatment on the nervous system by performing assessments just prior to DDN, immediately after DDN, 90 minutes after DDN, 24 hours after DDN, and 72 hours after DDN. These assessments will examine how you move your leg and how your nervous system responds to non-invasive nerve stimulation.

Group II: Non-Intervention Week Reflex MeasurementsActive Control1 Intervention

Baseline reflex measurements will be collected during the first week of the study (Visits 1-4). No dry needling will occur during this week. The aim of this arm is to track any natural variability in nervous system excitability at the same time points as reflex measurements during the intervention week.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Dry Needling

2020

Completed Phase 2

~1090

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