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

NCT06940492 | Recruiting

• 1 other identifier: IRB202500403
• Study Type: interventional
• Target: 71
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Chronic Low Back Pain (CLBP)

Keywords

low back pain; chronic low back pain; dry needling

Outcome Measures

Primary Outcomes (1)

• Pain intensity

  Pain intensity will be assessed using the Brief Pain Inventory's (BPI) pain intensity sub-scale. The BPI pain intensity sub-scale creates an average score of pain intensity by assessing four pain intensity domains of the current, best, and worst pain in the past twenty-four hours and pain on average, then adding these scores together and taking an average. The pain intensity domains are measured using the numeric pain rating scale (NPRS) anchored at "0" (no pain) and "10" (The worst pain imaginable).

  Will be collected at the baseline visit, seventy-two hour follow up, and at 2- and 4-week follow up. Current pain intensity will also be assessed at each dry needling session immediately before and immediately after receiving the intervention

Secondary Outcomes (1)

• Patient Reported Outcomes Measurement Inventory System version 2.0(PROMIS-29)

  PROMIS 29 subscales will be measured at baseline, at the needling session following the baseline visit, seventy-two hour follow up, and 2 and 4 week follow up

Other Outcomes (5)

• The Participant Global Impression of Change (PGIC)

  The PGIC will be administered at seventy-two-hour, two-week, and four-week follow-ups

• The Physical Impairment Index (PII)

  The PII will be administered at the baseline session, at each of the 3 dry needling sessions immediately before and immediately after receiving the intervention, and seventy-two-hour follow-up

• Myotonometry

  Myotonometry collection will occur at the baseline session, at each of the 3 needling session immediately before and immediately after receiving the intervention, and seventy-two-hour follow-up

Study Arms (1)

Dry needling

EXPERIMENTAL

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.

Other: Dry needling

Interventions

Dry needling OTHER

Dry needling is a force-based manipulation technique used by health care providers. Force-based manipulation describes when forces external to the body are passively applied to tissue with a therapeutic intent. During dry needling, a filiform needle (i.e., one without medication) is inserted into a muscle to target a trigger point, often times with the intent of eliciting a localized twitch response

Dry needling

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ages 18 - 65,
• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Florida: lead

Study Sites (1)

University of Florida

Gainesville, Florida, 32611, United States

RECRUITING

MeSH Terms

Conditions

Low Back Pain

Interventions

Dry Needling

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Physical Therapy Modalities

Central Study Contacts

Logan Rodgers, PT, DPT, PhD Student

CONTACT

352-733-1162; logan.rodgers@ufl.edu

Joel Bialosky, PT, PhD

CONTACT

352-733-1162; bialosky@phhp.ufl.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2025
• First Posted: April 23, 2025
• Study Start: May 12, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: February 27, 2026

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)