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

Primary Purpose

Low Back Pain

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Trigger point dry needling
Sham dry needling
Sponsored by
University of Florida
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain focused on measuring trigger point dry needling, quantitative sensory testing, low back pain

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • University of FloridaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Actual dry needling group

Sham dry needling group

Arm Description

Will receive actual dry needling of the lumbar multifidus with a 50-60mm filiform needle

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.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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
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

Secondary Outcome Measures

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
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
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"

Full Information

First Posted
April 5, 2023
Last Updated
July 5, 2023
Sponsor
University of Florida
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1. Study Identification

Unique Protocol Identification Number
NCT05845697
Brief Title
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

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 3, 2023 (Actual)
Primary Completion Date
May 31, 2024 (Anticipated)
Study Completion Date
May 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Florida

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain
Keywords
trigger point dry needling, quantitative sensory testing, low back pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Double blind, randomized control
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Actual dry needling group
Arm Type
Experimental
Arm Description
Will receive actual dry needling of the lumbar multifidus with a 50-60mm filiform needle
Arm Title
Sham dry needling group
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Trigger point dry needling
Intervention Description
Filiform needle that pierces the skin and is inserted into an identified trigger point in the muscle
Intervention Type
Other
Intervention Name(s)
Sham dry needling
Intervention Description
A validated sham dry needle that is blunted on the end and does not pierce the skin
Primary Outcome Measure Information:
Title
Change in Heat Thermal Pain Threshold degrees Celsius baseline and Heat Thermal Pain Threshold degrees Celsius immediately following intervention
Description
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.
Time Frame
Baseline and immediately following the intervention
Title
Change in Cold Thermal Pain Threshold degrees Celsius baseline and Cold Thermal Pain Threshold degrees Celsius immediately following intervention
Description
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.
Time Frame
Baseline and immediately following the intervention
Title
Change in Pressure Pain Threshold Kilopascals baseline and Pressure Pain Threshold Kilopascals immediately after following intervention
Description
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.
Time Frame
Baseline and immediately following the intervention
Title
Change in baseline Thermal Temporal Summation
Description
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.
Time Frame
Baseline and immediately following the intervention
Title
Change in baseline After sensation
Description
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
Time Frame
Baseline and immediately following the intervention
Title
Change in baseline Conditioned pain modulation
Description
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
Time Frame
Baseline and immediately following the intervention
Secondary Outcome Measure Information:
Title
Expectations
Description
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
Time Frame
Baseline, immediately following intervention
Title
Degree to which expectations met
Description
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
Time Frame
Immediately following follow pain testing
Title
Blinding
Description
Five point scale with 1= "strongly believe the treatment is active" and 3= "somewhat believe the treatment is placebo" and 5= "do not know"
Time Frame
Immediately following the assigned intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Logan J Rodgers, DPT
Phone
3527331162
Email
logan.rodgers@ufl.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joel Bialosky, PhD
Organizational Affiliation
University of Florida
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joel E Bialosky, PhD
Phone
352-273-8636
Email
bialosky@phhp.ufl.edu
First Name & Middle Initial & Last Name & Degree
Joel E Bialosky, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

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

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