Chronic Low Back Pain (CLBP)NCT06940492
A Mediation Analysis Investigating Dry Needling Treatment Mechanisms in a Chronic Low Back Pain Population
A study testing Dry needling in people with Chronic Low Back Pain (CLBP), run by University of Florida at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Low Back Pain (CLBP)
- What is being tested?
- Dry needling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteUnited States
- Study dates
- 12 May 2025to 4 Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ages 18 - 65,
- Currently experiencing pain in the space between the twelfth rib and the horizontal gluteal fold with or without radiating leg pain
- 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
Who cannot join
- 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
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- women who are pregnant or currently attempting to become pregnant
- diagnosis of active cancer
- inability to obtain the testing position (laying prone).
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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)
- Being tested
- Dry needling
- Keywords
- low back pain, chronic low back pain, dry needling
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dry needlingOther
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Dry needling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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)
The 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
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2025
- Study start12 May 2025
- Primary completion4 Apr 2026
- Study completion4 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Low Back Pain (CLBP)Studies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06940492
- Sponsor's protocol ID
- IRB202500403
- Status last verified
- Apr 2025
- First submitted
- 7 Apr 2025
- Last updated
- 4 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Mediation Analysis Investigating Dry Needling Treatment Mechanisms in a Chronic Low Back Pain Population
- ClinicalTrials.gov ID
- NCT06940492
- Acronym / sponsor ID
- IRB202500403
- Conditions
- Chronic Low Back Pain (CLBP)
- Keywords
- low back pain, chronic low back pain, dry needling
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- 12 May 2025 (actual)
- Primary completion
- 4 Apr 2026 (actual)
- Study completion
- 4 Apr 2026 (actual)
- First posted
- 23 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dry needling | Experimental | Other: Dry needlingThe 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Ages 18 - 65,
- Currently experiencing pain in the space between the twelfth rib and the horizontal gluteal fold with or without radiating leg pain
- 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
Key exclusion criteria (9 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dry needlingDry 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 | Other | Dry needling |
Primary outcome
Pain intensity
Time frame: 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
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).
1 secondary outcome
Patient Reported Outcomes Measurement Inventory System version 2.0(PROMIS-29)
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dry needling in people with Chronic Low Back Pain (CLBP), run by University of Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity (time frame: 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2026; AzTrials last refreshed its copy on 7 Nov 2026.