Immediate Effect of Dry Needling of the Lumbar Multifidus on Pain Sensitivity In A Healthy Population

NCT ID: NCT05845697

Last Updated: 2024-07-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-03
• Study Completion Date: 2024-04-13

Brief Summary

The goal of this interventional study is to test the effects of trigger point dry needling to the low back in a healthy population. The main aims are to answer:

• Is there a change in sensitivity to experimental pain after trigger point dry needling
• To determine if there is an association between demographic and psychological factors and immediate changes in pain sensitivity after receiving trigger point dry needling.

Participants will be randomly assigned to one of two groups a dry needling group or a sham dry needling group. The dry needling group will receive trigger point dry needling to the lumbar spine. The sham dry needling group will receive needling to the lumbar spine with a sham needle which does not penetrate the skin.

In other words, researchers will compare an intervention group and a sham group to see if dry needling has an immediate change in pain sensitivity in response to experimentally induced pain.

Detailed Description

The intent of this study is to investigate the effects of trigger point dry needling on pain sensitivity in a healthy population. In this study, the effects of trigger point dry needling will be measured using quantitative sensory testing. This is a method of testing pain sensitivity by providing a painful stimulus and having the participant rate their response to the stimulus on a pain scale. In this way, the researchers will be able to determine changes to participant's response to painful stimuli and changes to the nervous system after trigger point dry needling interventions to the low back. This information will provide important insight as to how dry needling modulates pain.

Conditions

Low Back Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Actual dry needling group

Will receive actual dry needling of the lumbar multifidus with a 50-60mm filiform needle

Group Type: EXPERIMENTAL

Trigger point dry needling

Intervention Type: OTHER

Filiform needle that pierces the skin and is inserted into an identified trigger point in the muscle

Sham dry needling group

Will receive needling from a sham needle that is blunted so it does not pierce the skin but has been shown to be valid for being indistinguishable from receiving an actual needle.

Group Type: SHAM_COMPARATOR

Sham dry needling

Intervention Type: OTHER

A validated sham dry needle that is blunted on the end and does not pierce the skin

Interventions

Trigger point dry needling

Filiform needle that pierces the skin and is inserted into an identified trigger point in the muscle

Intervention Type: OTHER

Sham dry needling

A validated sham dry needle that is blunted on the end and does not pierce the skin

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Ages 18 - 65
• Be pain-free

Exclusion Criteria

• a) Non-English speaker
• b) presence of a medical condition known to affect sensation
• c) history of surgery to the low back
• d) history of blood clotting disorders or medical conditions associated with bleeding disorders
• e) Current use of the medication causing difficulty with clotting (such as blood thinners)
• f) Contraindication to the application of needles including, but not limited to, fear of needles or metal allergy --g) women who are pregnant or planning on becoming pregnant any contraindication to application of ice or cold pack, such as: uncontrolled hypertension, cold urticaria, cryoglobulinemia, paroxysmal cold hemoglobinuria, and circulatory compromise.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Florida

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Joel Bialosky, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Florida

Locations

University of Florida

Gainesville, Florida, United States

Countries

United States

Other Identifiers

IRB202202632

Identifier Type: -

Identifier Source: org_study_id