Clinical trial NCT05845697: Immediate Effect of Dry Needling of the Lumbar Multifidus on Pain Sensitivity In A Healthy Population
Official title: Immediate Effect of Dry Needling of the Lumbar Multifidus on Pain Sensitivity In A Healthy Population
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low Back Pain
Keywords: trigger point dry needling
quantitative sensory testing
low back pain
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2023-05-06
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Double blind, randomized control
Primary purpose: TREATMENT

Brief 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 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.

Eligibility criteria: Inclusion Criteria:

* Ages 18 - 65
* Be pain-free

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Change in Heat Thermal Pain Threshold degrees Celsius baseline and Heat Thermal Pain Threshold degrees Celsius immediately following intervention
timeFrame: Baseline and immediately following the intervention
measure: Change in Cold Thermal Pain Threshold degrees Celsius baseline and Cold Thermal Pain Threshold degrees Celsius immediately following intervention
timeFrame: Baseline and immediately following the intervention
measure: Change in Pressure Pain Threshold Kilopascals baseline and Pressure Pain Threshold Kilopascals immediately after following intervention
timeFrame: Baseline and immediately following the intervention
measure: Change in baseline Thermal Temporal Summation
timeFrame: Baseline and immediately following the intervention
measure: Change in baseline After sensation
timeFrame: Baseline and immediately following the intervention
measure: Change in baseline Conditioned pain modulation
timeFrame: Baseline and immediately following the intervention
Secondary outcomes:
measure: Expectations
timeFrame: Baseline, immediately following intervention
measure: Degree to which expectations met
timeFrame: Immediately following follow pain testing
measure: Blinding
timeFrame: Immediately following the assigned intervention
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida
state: Florida
Study officials:
affiliation: University of Florida
name: Joel Bialosky, PhD
role: PRINCIPAL_INVESTIGATOR
References: