Clinical trial NCT06940492: A Mediation Analysis Investigating Dry Needling Treatment Mechanisms in a Chronic Low Back Pain Population
Official title: A Mediation Analysis Investigating Dry Needling Treatment Mechanisms in a Chronic Low Back Pain Population
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Low Back Pain (CLBP)
Keywords: low back pain
chronic low back pain
dry needling
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2025-04-23
Enrollment: 71
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility criteria: 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).

Primary outcomes:
measure: Pain intensity
timeFrame: 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:
measure: Patient Reported Outcomes Measurement Inventory System version 2.0(PROMIS-29)
timeFrame: 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:
measure: The Participant Global Impression of Change (PGIC)
timeFrame: The PGIC will be administered at seventy-two-hour, two-week, and four-week follow-ups
measure: The Physical Impairment Index (PII)
timeFrame: 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
measure: Myotonometry
timeFrame: 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
measure: Pressure pain threshold
timeFrame: Pressure pain threshold measures will be collected at the baseline session, at each of the 3 needling session immediately before and immediately after receiving the intervention, and at seventy-two-hour follow-up
measure: Pain catastrophizing scale (PCS)
timeFrame: The PCS will be collected at the dry needling session number 1 (the session following the baseline session) and seventy-two-hour follow-up
Locations:
city: Gainesville
country: United States
facility: University of Florida
state: Florida
Study officials:
References: