A Mediation Analysis Investigating Dry Needling Treatment Mechanisms in a Chronic Low Back Pain Population

University of Florida

Status: Enrolling

Conditions: Chronic Low Back Pain (CLBP)

Treatments: Other: Dry needling

Study type: Interventional

Funder types: Other

Identifiers

NCT06940492

IRB202500403

Details and patient eligibility

About

Low back pain is a common problem that many adults experience at some point in their lives. One treatment being studied is dry needling, a technique where a small needle is inserted into a specific area of muscle to help relieve pain. So far, the research on dry needling for low back pain hasn't been clear, and it's hard to know when and for whom it will work best. This study aims to figure out how dry needling works to help people with chronic low back pain by looking at the underlying factors. By understanding how dry needling helps people, we can develop a more targeted approach to treatment, which could lead to better outcomes for people with chronic low back pain. The goal of this study is to identify the factors that make dry needling effective for people with chronic low back pain, so that this this information can be used to provide more personalized and effective care.

Eligible participants will attend 5 research sessions lasting approximately 1 hour and complete 2 online surveys. At 3 of those sessions, participants will receive dry needling to their low back.

As part of the research, participants will complete questionnaires related to how pain effects their life. Participants will also undergo testing for muscle stiffness, low back mobility and strength, and pain sensitivity.

To be included in this study participants must:

• Be 18-65 years of age
• Have low back pain for at least 3 months

Enrollment: 71 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Ages 18 - 65,
2. Currently experiencing pain in the space between the twelfth rib and the horizontal gluteal fold with or without radiating leg pain

b) Low back pain symptoms that are chronic, in that symptoms, have persisted for at least 3 months with pain experienced on most or every day in the past 3 months c) Not currently receiving treatment for their low back

Exclusion criteria

1. Non-English speaker
2. presence of a medical condition known to affect sensation
3. history of surgery to the low back
4. history of blood clotting disorders or medical conditions associated with bleeding disorders
5. Current use of the medication causing difficulty with clotting (such as blood thinners)
6. Contraindication to the application of needles including, but not limited to, diabetes, local infection, epilepsy, fear of needles or metal allergy
7. women who are pregnant or currently attempting to become pregnant
8. diagnosis of active cancer
9. inability to obtain the testing position (laying prone).

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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71 participants in 1 patient group

Dry needling

Experimental group

Description:

The participant will be placed prone. The skin on each side of the spine at the level of the identified trigger point will be prepped and cleaned with an alcohol swab. Four 50mm - 60 mm filiform needles will be used to penetrate the skin in the lower back; two needles will be inserted bilaterally on each side of the spine at the level of the trigger point. Needles will be placed approximately 1.5cm lateral to the spinous process, directed at a 20 to 30-degree inferior medial angle into the lumbar multifidus. Needles will be manipulated with an "in and out" pistoning technique for 5 - 10 seconds when first inserted into the muscle. After 5 -10 second , the needles will be left resting in the muscle for 10 minutes. Participants will receive 3 sessions of dry needling. Each session will be approximately 72-96 hours apart.

Treatment:

Other: Dry needling