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

Low Back Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05845697
• Other study ID #: IRB202202632
• Status: Recruiting
• Phase: N/A
• Start date: June 3, 2023
• Est. completion date: May 31, 2024

Study information

• Verified date: July 2023
• Source: University of Florida
• Contact: Logan J Rodgers, DPT
• Phone: 3527331162
• Email: logan.rodgers[@]ufl.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: May 31, 2024
• Est. primary completion date: May 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Intervention

Other:
• Trigger point dry needling
Filiform needle that pierces the skin and is inserted into an identified trigger point in the muscle
• Sham dry needling
A validated sham dry needle that is blunted on the end and does not pierce the skin

Locations

Country	Name	City	State
United States	University of Florida	Gainesville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Florida

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Secondary	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
Secondary	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
Secondary	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