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Dry Needling + Exercises for Neck Pain
N/A
Waitlist Available
Led By Ray Lunasin, PT, DPT
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 5 weeks
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
I have trouble sleeping, scoring 8 or more on the Insomnia Severity Index.
Select...
I have had neck pain for more than 3 months.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, 5 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 5 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in sleep duration
Change in sleep quality
Secondary outcome measures
Change in dysfunction
Change in pain level
Trial Design
1Treatment groups
Experimental Treatment
Group I: Exercise and dry needlingExperimental Treatment2 Interventions
Subjects will complete a 5 day a week exercise program and 1 session per week standard of care dry needling for 4 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Home Exercise Program
2019
Completed Phase 3
~760
Dry Needling
2020
Completed Phase 2
~1090
Find a Location
Who is running the clinical trial?
Mayo ClinicLead Sponsor
3,206 Previous Clinical Trials
3,767,073 Total Patients Enrolled
3 Trials studying Neck Pain
59 Patients Enrolled for Neck Pain
Ray Lunasin, PT, DPTPrincipal InvestigatorMayo Clinic
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a condition like rheumatoid arthritis affecting my joints.I have trouble sleeping, scoring 8 or more on the Insomnia Severity Index.I have a disorder affecting my brain or nerves.I have symptoms like weak muscles, numbness, or less reflexes due to nerve issues.I do not have serious conditions like fractures, infections, tumors, or spinal issues.You are currently involved in a legal case or workers' compensation related to your neck pain.I do not have a fear of needles, bleeding disorders, abnormal reactions to needles, or take blood thinners.I have had surgery on my neck or upper back.I have had neck pain for more than 3 months.I have Raynaud's disease.I have a condition that weakens my immune system, like diabetes, HIV, or lupus.
Research Study Groups:
This trial has the following groups:- Group 1: Exercise and dry needling
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is elderly participation sought in this clinical trial?
"Eligible participants must be of legal age and under the age of retirement to take part in this clinical trial."
Answered by AI
Does this medical experiment have any vacancies for participants?
"Per clinicaltrials.gov, this trial is no longer recruiting patients despite the initial posting of the study on May 8th 2023 and a subsequent update made on that same day. Fortunately, there are 81 other trials currently enrolling participants at present."
Answered by AI
What qualifications must a person meet in order to be eligible for enrollment in this research program?
"To qualify for this medical trial, prospective candidates must experience neck pain and be within the age range of 18 to 65. At present, there are plans to recruit up to 10 participants."
Answered by AI
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