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Procedure

Intramuscular Dry-Needling for Lower Back Pain

N/A
Recruiting
Led By Dominic Severino, PT,DPT
Research Sponsored by Whitworth University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participants must also report an Oswestry Disability Index score of at least 20/100 points.
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, week 1, week 2 and week 3
Awards & highlights

Study Summary

This trial aims to find out which specific clinical characteristics of people with low back pain make them suitable for a treatment called Intermuscular Dry-Needling (IMDN). The researchers also want to

Who is the study for?
This trial is for individuals experiencing lower back pain. It aims to find out which patients are likely to benefit from a treatment called Intramuscular Dry-Needling (IMDN).Check my eligibility
What is being tested?
The study is testing the effectiveness of IMDN in treating low back pain and developing a tool to predict who will respond well to this therapy.See study design
What are the potential side effects?
Possible side effects of IMDN may include temporary soreness, bruising at the needle site, muscle aches, or minor bleeding.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My back pain affects my daily activities.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, week 1, week 2 and week 3
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, week 1, week 2 and week 3 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Oswestry Disability Index
Secondary outcome measures
11 point Numeric Pain-Rating Scale
Fear-Avoidance Beliefs Questionnaire

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Intramuscular Dry-NeedlingExperimental Treatment1 Intervention
(IMDN) is a minimally invasive procedure where a solid filament needle is inserted into a myofascial trigger point.
Group II: Sham Intramuscular Dry-NeedlingPlacebo Group1 Intervention
). Park sham acupuncture needles (AcuPrime) will be used to perform sham needling for this group. The sham needle functions by allowing the blunted needle to cause a pricking sensation when pushed against the skin, but does not penetrate. This will allow the patient to perceive that the needle is entering the skin while also maintaining therapist-patient contact and interaction time

Find a Location

Who is running the clinical trial?

Whitworth UniversityLead Sponsor
Dominic Severino, PT,DPTPrincipal InvestigatorWhitworth University

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the enrollment for this research study open to participants above the age of 30?

"This clinical trial is seeking individuals who are over 18 years old but under the age of 60."

Answered by AI

What is the current number of participants receiving treatment in this clinical trial?

"Indeed, as stated on clinicaltrials.gov, this study is actively seeking individuals to participate. The initial posting of the trial occurred on January 1st, 2024 and it was last updated on January 11th, 2024. The study aims to recruit a total of 85 participants from one location."

Answered by AI

Is it possible for individuals to participate in this clinical trial?

"To be eligible for participation in this clinical trial, potential participants must have a diagnosis of lower back pain and fall within the age range of 18 to 60. The study aims to recruit approximately 85 individuals."

Answered by AI

Are new participants currently being accepted for enrollment in this ongoing medical study?

"According to the data provided on clinicaltrials.gov, this ongoing medical trial is actively seeking eligible participants. The study was first published on January 1st, 2024 and underwent its most recent update on January 11th, 2024."

Answered by AI

Who else is applying?

What site did they apply to?
Whitworth University
What portion of applicants met pre-screening criteria?
Met criteria

Why did patients apply to this trial?

Recent research and studies
clinicaltrials.govStudy
The Derivation of a Clinical Prediction Rule to Identify Those With Low Back Pain Who Will Respond Favorably to Intramuscular Dry-needling
Dominic Severino 2024. "The Derivation of a Clinical Prediction Rule to Identify Those With Low Back Pain Who Will Respond Favorably to Intramuscular Dry-needling". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06204055.
All > Low Back Pain > Spokane
~36 spots leftby Aug 2024
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