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Dry Needling + Exercises for Neck Pain

N/A
Waitlist Available
Led By Ray Lunasin, PT, DPT, PhD
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Presence of sleep disturbance - to be defined as a score ≥ 8 on the Insomnia Severity Index.
Neck pain lasting greater than 3 months
Must not have
Systemic joint disease (e.g. rheumatoid arthritis)
Central nervous system disorders
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 4 weeks and 8 weeks post-intervention
Awards & highlights
No Placebo-Only Group

Summary

This trial looks at dry needling and exercises to see if they help people with chronic neck pain and sleep issues sleep better and longer.

Who is the study for?
This trial is for adults with chronic neck pain lasting over 3 months and sleep problems, as indicated by a score of 8 or higher on the Insomnia Severity Index. It's not suitable for pregnant individuals, those lacking English proficiency to complete surveys, people involved in neck pain litigation, or those with central nervous system disorders, prior neck surgery, systemic joint diseases like rheumatoid arthritis, serious conditions such as cancer or immunocompromised states.
What is being tested?
The study investigates if combining dry needling with a home exercise program can improve sleep quality and duration for people suffering from long-term neck pain and disturbed sleep. Participants will receive both treatments and their effects on sleep will be compared.
What are the potential side effects?
Dry needling may cause some discomfort at the needle site, minor bleeding or bruising. There's also a low risk of infection. The home exercise program might lead to muscle soreness initially.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have trouble sleeping, scoring 8 or more on the Insomnia Severity Index.
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I have had neck pain for more than 3 months.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a condition like rheumatoid arthritis affecting my joints.
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I have a disorder affecting my brain or nerves.
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I have symptoms like weak muscles, numbness, or less reflexes due to nerve issues.
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I do not have serious conditions like fractures, infections, tumors, or spinal issues.
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I do not have a fear of needles, bleeding disorders, abnormal reactions to needles, or take blood thinners.
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I have had surgery on my neck or upper back.
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I have Raynaud's disease.
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I have a condition that weakens my immune system, like diabetes, HIV, or lupus.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 4 weeks and 8 weeks post-intervention
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 4 weeks and 8 weeks post-intervention for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in Restless Legs Syndrome symptom severity
Change in periodic limb movement
Change in sleep quality
Secondary study objectives
Acute change in Restless Legs Syndrome symptoms
Change in pain level
Change in quality of life

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Dry needling with electrical stimulationExperimental Treatment1 Intervention
Participants with restless legs syndrome will receive dry needling with electrical stimulation to the lower extremities

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor
3,339 Previous Clinical Trials
3,062,125 Total Patients Enrolled
3 Trials studying Neck Pain
59 Patients Enrolled for Neck Pain
Ray Lunasin, PT, DPT, PhDPrincipal InvestigatorMayo Clinic
Ray Lunasin, PT, DPTPrincipal InvestigatorMayo Clinic

Media Library

Home Exercise Program Clinical Trial Eligibility Overview. Trial Name: NCT05860751 — N/A
Neck Pain Research Study Groups: Dry needling with electrical stimulation
Neck Pain Clinical Trial 2023: Home Exercise Program Highlights & Side Effects. Trial Name: NCT05860751 — N/A
Home Exercise Program 2023 Treatment Timeline for Medical Study. Trial Name: NCT05860751 — N/A
~13 spots leftby Apr 2025
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