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Completed

NCT Number: NCT05845697

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.

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Key information

Conditions

Low Back Pain Back Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Florida

Gainesville, Florida, 32610, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Trigger point dry needling

Other

Filiform needle that pierces the skin and is inserted into an identified trigger point in the muscle

Sham dry needling

Other

A validated sham dry needle that is blunted on the end and does not pierce the skin

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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

  6. 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

Secondary outcomes

  1. Expectations

    Time frame: Baseline, immediately following intervention

    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

  2. Degree to which expectations met

    Time frame: Immediately following follow pain testing

    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

  3. Blinding

    Time frame: Immediately following the assigned intervention

    Five point scale with 1= "strongly believe the treatment is active" and 3= "somewhat believe the treatment is placebo" and 5= "do not know"

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
May 6, 2023
Registry last updated
Jul 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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