Immediate Effect of Dry Needling of the Lumbar Multifidus on Pain Sensitivity In A Healthy Population

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.

Study Overview

• Status: Recruiting
• Conditions: Low Back Pain
• Intervention / Treatment: Other: Trigger point dry needling; Other: Sham dry needling

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 Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Logan J Rodgers, DPT; Phone Number: 3527331162; Email: logan.rodgers@ufl.edu

Study Locations

• United States
  • Florida
    • Gainesville, Florida, United States, 32610
      • Recruiting
      • University of Florida
      • Contact: Joel E Bialosky, PhD; Phone Number: 352-273-8636; Email: bialosky@phhp.ufl.edu
      • Principal Investigator: Joel E Bialosky, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Actual dry needling group; Will receive actual dry needling of the lumbar multifidus with a 50-60mm filiform needle	Other: Trigger point dry needling; Filiform needle that pierces the skin and is inserted into an identified trigger point in the muscle
Sham Comparator: Sham dry needling group; 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.	Other: Sham dry needling; A validated sham dry needle that is blunted on the end and does not pierce the skin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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	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	Baseline and immediately following the intervention
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.	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.	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.	Baseline and immediately following the intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	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"	Immediately following the assigned intervention

Collaborators and Investigators

• Sponsor: University of Florida
• Investigators: Principal Investigator: Joel Bialosky, PhD, University of Florida

Study record dates

Study Major Dates

• Study Start (Actual): June 3, 2023
• Primary Completion (Estimated): May 31, 2024
• Study Completion (Estimated): May 31, 2024

Study Registration Dates

• First Submitted: April 5, 2023
• First Submitted That Met QC Criteria: April 25, 2023
• First Posted (Actual): May 6, 2023

Study Record Updates

• Last Update Posted (Actual): July 7, 2023
• Last Update Submitted That Met QC Criteria: July 5, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: low back pain; quantitative sensory testing; trigger point dry needling
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: IRB202202632

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No