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

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06940492
Enrollment
56
Registered
2025-04-23
Start date
2025-05-12
Completion date
2026-04-04
Last updated
2026-06-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Low Back Pain (CLBP)

Keywords

low back pain, chronic low back pain, dry needling

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

Interventions

OTHERDry needling

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

Sponsors

University of Florida
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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).

Design outcomes

Primary

MeasureTime frameDescription
Pain intensityWill 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 interventionPain 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).

Secondary

MeasureTime frameDescription
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 upThe PROMIS-29 is a National Institute of Health-supported outcome measure that assesses multiple domains, including pain intensity with the NPRS an average of pain in the past seven days, physical function, fatigue, pain interference, ability to participate in social roles and activity, symptoms of anxiety, symptoms of depression, and sleep disturbance

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 5, 2026