Low Back PainNCT05845697
Immediate Effect of Dry Needling of the Lumbar Multifidus on Pain Sensitivity In A Healthy Population
A study testing Trigger point dry needling in people with Low Back Pain, run by University of Florida at 1 site in United States.
Trial summary
The goal of this interventional study is to test the effects of trigger point dry needling to the low back in a healthy population. The main aims are to answer: Is there a change in sensitivity to experimental pain after trigger point dry needling To determine if there is an association between demographic and… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Trigger point dry needling
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Jun 2023to 13 Apr 2024
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Ages 18 - 65
- Be pain-free
Who cannot join
- Participants will not be excluded on the basis of race or gender but will be excluded if they meet any of the following exclusion criteria:
- a) Non-English speaker
- b) presence of a medical condition known to affect sensation
- c) history of surgery to the low back
- d) history of blood clotting disorders or medical conditions associated with bleeding disorders
- e) Current use of the medication causing difficulty with clotting (such as blood thinners)
- f) Contraindication to the application of needles including, but not limited to, fear of needles or metal allergy --g) women who are pregnant or planning on becoming pregnant any contraindication to application of ice or cold pack, such as: uncontrolled hypertension, cold urticaria, cryoglobulinemia, paroxysmal cold hemoglobinuria, and circulatory compromise.
Trial locations and contacts
1 site in 1 country.
About this study
The goal of this interventional study is to test the effects of trigger point dry needling to the low back in a healthy population. The main aims are to answer:
- Is there a change in sensitivity to experimental pain after trigger point dry needling
- To determine if there is an association between demographic and psychological factors and immediate changes in pain sensitivity after receiving trigger point dry needling.
Read more
Participants will be randomly assigned to one of two groups a dry needling group or a sham dry needling group. The dry needling group will receive trigger point dry needling to the lumbar spine. The sham dry needling group will receive needling to the lumbar spine with a sham needle which does not penetrate the skin.
In other words, researchers will compare an intervention group and a sham group to see if dry needling has an immediate change in pain sensitivity in response to experimentally induced pain.
Read the detailed description
The intent of this study is to investigate the effects of trigger point dry needling on pain sensitivity in a healthy population. In this study, the effects of trigger point dry needling will be measured using quantitative sensory testing. This is a method of testing pain sensitivity by providing a painful stimulus and having the participant rate their response to the stimulus on a pain scale. In this way, the researchers will be able to determine changes to participant's response to painful stimuli and changes to the nervous system after trigger point dry needling interventions to the low back. This information will provide important insight as to how dry needling modulates pain.
- Conditions
- Low Back Pain
- Being tested
- Trigger point dry needling, Sham dry needling
- Keywords
- trigger point dry needling, quantitative sensory testing, low back pain
- 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.
Trigger point dry needlingOther
Filiform needle that pierces the skin and is inserted into an identified trigger point in the muscle
Sham dry needlingOther
A validated sham dry needle that is blunted on the end and does not pierce the skin
| Study group | Role | What they receive |
|---|---|---|
| Actual dry needling group | Experimental | Will receive actual dry needling of the lumbar multifidus with a 50-60mm filiform needle Receives: Other: Trigger point dry needling |
| Sham dry needling group | Sham comparator | Will receive needling from a sham needle that is blunted so it does not pierce the skin but has been shown to be valid for being indistinguishable from receiving an actual needle. Receives: Other: Sham dry needling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Heat Thermal Pain Threshold degrees Celsius baseline and Heat Thermal Pain Threshold degrees Celsius immediately following intervention
Participants will indicate when an thermode of ascending temperatures first changes from a sensation of warmth to painful by saying "pain" and indicating the amount of pain with a visual analog scale. This change will be calculated by taking the difference between the two scores.
Measured: Baseline and immediately following the intervention
Change in Cold Thermal Pain Threshold degrees Celsius baseline and Cold Thermal Pain Threshold degrees Celsius immediately following intervention
Participants will indicate when an thermode of descending temperatures first changes from a sensation of cold to painful by saying "pain" and indicating the amount of pain with a visual analog scale. This change will be calculated by taking the difference between the two scores.
Measured: Baseline and immediately following the intervention
Change in Pressure Pain Threshold Kilopascals baseline and Pressure Pain Threshold Kilopascals immediately after following intervention
Participants will indicate when ascending pressure from an algometer first changes from a sensation of pressure to painful by saying "pain" and indicating the amount of pain with a visual analog scale. This change will be calculated by taking the difference between the two scores.
Measured: Baseline and immediately following the intervention
Change in baseline Thermal Temporal Summation
Participants will rate the pain associated with a series of 10 heat pulses applied to the skin on a 0 to 100 numerical rating scale with 0= no pain to 100= worst pain imaginable.
Measured: Baseline and immediately following the intervention
Change in baseline After sensation
After sensation is the term used to describe the measurement of pain that remains after a painful stimulus.
Participants will rate the pain remaining every 15 seconds for a total of one minute following the final thermal pulse in the Thermal Temporal Summation protocol (as described in outcomes 4). The numeric rating scale is (0 - 100) with "0" being no pain at all and "100" being worst pain imaginable
Measured: Baseline and immediately following the intervention
Change in baseline Conditioned pain modulation
Pressure pain threshold will be assessed immediately prior to and following a pain inducing cold water bath immersion. Condition pain modulation will be defined by the changes in pressure pain threshold prior to and immediately following the cold water bath immersion
Measured: Baseline and immediately following the intervention
Secondary outcomes (3)
Expectations
Expectation will be assessed using a 15 point global rating of change anchored with -7= expect a very great deal more pain; 0= unchanged, and 7= a very great deal less pain
Measured: Baseline, immediately following intervention
Degree to which expectations met
Single question, In response to the pain testing, participants will be asked to indicate, "How would you describe how you feel now compared to how you expected" categorically, with "more", "less", or "expected" level of pain
Measured: Immediately following follow pain testing
Blinding
Five point scale with 1= "strongly believe the treatment is active" and 3= "somewhat believe the treatment is placebo" and 5= "do not know"
Measured: Immediately following the assigned intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2023
- Study start3 Jun 2023
- Primary completion13 Apr 2024
- Study completion13 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Low Back PainStudies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double blind, randomized control
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Joel Bialosky, PhD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05845697
- Sponsor's protocol ID
- IRB202202632
- Status last verified
- Jul 2024
- First submitted
- 5 Apr 2023
- Last updated
- 23 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rodgers L, Bruck J, Blanchard E, Bialosky J. Double-blind randomized control trial investigating immediate changes in pain processing measures in response to dry needling to the lumbar multifidus in an asymptomatic population. J Bodyw Mov Ther. 2026 Jun;46:356-364. doi: 10.1016/j.jbmt.2025.11.022. Epub 2025 Nov 21.
PubMed 41927194
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immediate Effect of Dry Needling of the Lumbar Multifidus on Pain Sensitivity In A Healthy Population
- ClinicalTrials.gov ID
- NCT05845697
- Acronym / sponsor ID
- IRB202202632
- Conditions
- Low Back Pain
- Keywords
- trigger point dry needling, quantitative sensory testing, low back pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- 3 Jun 2023 (actual)
- Primary completion
- 13 Apr 2024 (actual)
- Study completion
- 13 Apr 2024 (actual)
- First posted
- 6 May 2023 (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.
The goal of this interventional study is to test the effects of trigger point dry needling to the low back in a healthy population. The main aims are to answer:
- Is there a change in sensitivity to experimental pain after trigger point dry needling
- To determine if there is an association between demographic and psychological factors and immediate changes in pain sensitivity after receiving trigger point dry needling.
Participants will be randomly assigned to one of two groups a dry needling group or a sham dry needling group. The dry needling group will receive trigger point dry needling to the lumbar spine. The sham dry needling group will receive needling to the lumbar spine with a sham needle which does not penetrate the skin.
In other words, researchers will compare an intervention group and a sham group to see if dry needling has an immediate change in pain sensitivity in response to experimentally induced pain.
Detailed description
The intent of this study is to investigate the effects of trigger point dry needling on pain sensitivity in a healthy population. In this study, the effects of trigger point dry needling will be measured using quantitative sensory testing. This is a method of testing pain sensitivity by providing a painful stimulus and having the participant rate their response to the stimulus on a pain scale. In this way, the researchers will be able to determine changes to participant's response to painful stimuli and changes to the nervous system after trigger point dry needling interventions to the low back. This information will provide important insight as to how dry needling modulates pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Double blind, randomized control
| Arm | Type | Receives |
|---|---|---|
| Actual dry needling group | Experimental | Other: Trigger point dry needlingWill receive actual dry needling of the lumbar multifidus with a 50-60mm filiform needle |
| Sham dry needling group | Sham comparator | Other: Sham dry needlingWill receive needling from a sham needle that is blunted so it does not pierce the skin but has been shown to be valid for being indistinguishable from receiving an actual needle. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Ages 18 - 65
- Be pain-free
Key exclusion criteria (7 listed)
- Participants will not be excluded on the basis of race or gender but will be excluded if they meet any of the following exclusion criteria:
- a) Non-English speaker
- b) presence of a medical condition known to affect sensation
- c) history of surgery to the low back
- d) history of blood clotting disorders or medical conditions associated with bleeding disorders
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 |
|---|---|---|
| Trigger point dry needlingFiliform needle that pierces the skin and is inserted into an identified trigger point in the muscle | Other | Actual dry needling group |
| Sham dry needlingA validated sham dry needle that is blunted on the end and does not pierce the skin | Other | Sham dry needling group |
Primary outcome
Change in Heat Thermal Pain Threshold degrees Celsius baseline and Heat Thermal Pain Threshold degrees Celsius immediately following intervention
Time frame: Baseline and immediately following the intervention
Participants will indicate when an thermode of ascending temperatures first changes from a sensation of warmth to painful by saying "pain" and indicating the amount of pain with a visual analog scale. This change will be calculated by taking the difference between the two scores.
Change in Cold Thermal Pain Threshold degrees Celsius baseline and Cold Thermal Pain Threshold degrees Celsius immediately following intervention
Time frame: Baseline and immediately following the intervention
Participants will indicate when an thermode of descending temperatures first changes from a sensation of cold to painful by saying "pain" and indicating the amount of pain with a visual analog scale. This change will be calculated by taking the difference between the two scores.
Change in Pressure Pain Threshold Kilopascals baseline and Pressure Pain Threshold Kilopascals immediately after following intervention
Time frame: Baseline and immediately following the intervention
Participants will indicate when ascending pressure from an algometer first changes from a sensation of pressure to painful by saying "pain" and indicating the amount of pain with a visual analog scale. This change will be calculated by taking the difference between the two scores.
Change in baseline Thermal Temporal Summation
Time frame: Baseline and immediately following the intervention
Participants will rate the pain associated with a series of 10 heat pulses applied to the skin on a 0 to 100 numerical rating scale with 0= no pain to 100= worst pain imaginable.
Change in baseline After sensation
Time frame: Baseline and immediately following the intervention
After sensation is the term used to describe the measurement of pain that remains after a painful stimulus. Participants will rate the pain remaining every 15 seconds for a total of one minute following the final thermal pulse in the Thermal Temporal Summation protocol (as described in outcomes 4). The numeric rating scale is (0 - 100) with "0" being no pain at all and "100" being worst pain imaginable
Change in baseline Conditioned pain modulation
Time frame: Baseline and immediately following the intervention
Pressure pain threshold will be assessed immediately prior to and following a pain inducing cold water bath immersion. Condition pain modulation will be defined by the changes in pressure pain threshold prior to and immediately following the cold water bath immersion
3 secondary outcomes
Expectations
Time frame: Baseline, immediately following intervention
Degree to which expectations met
Time frame: Immediately following follow pain testing
Blinding
Time frame: Immediately following the assigned intervention
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 23 Jul 2024.
- Derived from this study: PubMed 41927194Rodgers L, Bruck J, Blanchard E, Bialosky J. Double-blind randomized control trial investigating immediate changes in pain processing measures in response to dry needling to the lumbar multifidus in an asymptomatic population. J Bodyw Mov Ther. 2026 Jun;46:356-364. doi: 10.1016/j.jbmt.2025.11.022. Epub 2025 Nov 21.
- 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.
Joel Bialosky, PhD principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Trigger point dry needling in people with Low Back Pain, 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 2 inclusion and 7 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 23 Jul 2024. 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. Some participants in this study may receive a placebo. 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?
Change in Heat Thermal Pain Threshold degrees Celsius baseline and Heat Thermal Pain Threshold degrees Celsius immediately following intervention (time frame: Baseline and immediately following the intervention). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05845697, which also lists 1 linked publication.
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 23 Jul 2024.