Recruiting

Intramuscular Dry-needling

Sponsor:

Whitworth University

Code:

NCT06204055

Conditions

Low Back Pain

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Accepted

Interventions

Intramuscular Dry-Needling

Study Details

Brief summary:

The purpose of this study is to investigate specific clinical characteristics, amongst those with low back pain, that identify patient appropriateness for Intermuscular Dry-Needling (IMDN) and to develop a prediction tool that can be used by clinicians.

Conditions

Low Back Pain

Study ID

NCT06204055

Start date

Jan, 2024

Status verified date

Jan, 2024

Completion date

Nov, 2024

Anticipated

Primary completion date

Aug, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Males and females between the ages of 18 and 60 years with non-traumatic low back pain between the 12th rib and the buttock region.
  • Participants must also report an Oswestry Disability Index score of at least 20/100 points.

Exclusion Criteria:

  • Participants must be able to speak and read English.
  • Individuals who are currently pregnant, currently taking pain narcotic medication or have had a prior surgery in the lumbosacral spine
  • Those participants whose BMI is greater than 35

Study Design

Enrollment

85 participants

Anticipated

Allocation

Randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Intramuscular Dry-Needling

(IMDN) is a minimally invasive procedure where a solid filament needle is inserted into a myofascial trigger point.

sham comparator: Sham Intramuscular Dry-Needling

). 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

Interventions

Intramuscular Dry-Needling

It is a minimally invasive procedure where a solid filament needle is inserted deeply into a myofascial trigger point (MTrP) within a muscle in an attempt to abate it and illicit a desired treatment effect.

Primary outcome measure

  • Oswestry Disability Index [ Time Frame: Baseline, week 1, week 2 and week 3 ]

Central Contacts and Locations

Central contacts

Dominic J Severino, PT,DPT

5097774687dseverino@whitworth.edu

Locations

Whitworth University

Recruiting

Spokane, Washington, United States, 99251

Contacts

Dominic Severino

509-777-4687dseverino@whitworth.edu

dseverino@whitworth.edu

Principal Investigator:

Dominic Severino

More Information

Sponsor

Whitworth University

Last update posted

Jan 12, 2024

Last verified

Jan, 2024

Keywords

  • Low Back Pain
  • Dry-Needling
  • Myofascial Pain
  • Treatment Based Classification

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Whitworth University on 2024-01-12.