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临床试验/NCT05845697
NCT05845697已完成不适用

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

University of Florida2 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2023年6月3日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
34
试验地点
2
主要终点
Change in Cold Thermal Pain Threshold degrees Celsius baseline and Cold Thermal Pain Threshold degrees Celsius immediately following intervention

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Ages 18 - 65
  • Be pain-free

排除标准

  • 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.

结局指标

主要结局

Change in Cold Thermal Pain Threshold degrees Celsius baseline and Cold Thermal Pain Threshold degrees Celsius immediately following intervention

时间窗: 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.

Change in Pressure Pain Threshold Kilopascals baseline and Pressure Pain Threshold Kilopascals immediately after following intervention

时间窗: 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.

Change in baseline Conditioned pain modulation

时间窗: 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

Change in Heat Thermal Pain Threshold degrees Celsius baseline and Heat Thermal Pain Threshold degrees Celsius immediately following intervention

时间窗: 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.

Change in baseline After sensation

时间窗: 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

Change in baseline Thermal Temporal Summation

时间窗: 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.

次要结局

  • Degree to which expectations met(Immediately following follow pain testing)
  • Blinding(Immediately following the assigned intervention)
  • Expectations(Baseline, immediately following intervention)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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