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临床试验/NCT05165277
NCT05165277终止不适用

Effect of Flow Rate and PH on Muscle Acidosis

Taipei Medical University Hospital1 个研究点 分布在 1 个国家目标入组 14 人开始时间: 2019年7月4日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
终止
入组人数
14
试验地点
1
主要终点
The visual analog scale (VAS) of "sng" in the legs

研究概览

简要总结

This proposed study suggests that peripheral tissue acidosis sensed by the somatosensory system (sngception) would evoke the sng perception in the brain. This hypothesis is based on investigators preliminary data that the peripheral muscle acidosis will evoked the central sng perception. In this study, investigators want to determine if there is the correlation between the flow rate of drug application and sng or pain. Also, they try to find if the pH of a solution will affect muscle acidosis.

详细描述

Sng is a prominent complaint in Taiwanese people with low back pain. "Sng" is created to represent this Taiwanese word- 痠. Based on our preliminary data, sng was one of the most common complaints in patients with chronic low back pain (CLBP) and also one of the most common indication for lumbar spine operations. Back sng is not adequately relieved by pain-killers or even by the lumbar spine operations. By using functional MRI and questionnaires, our preliminary study demonstrated that sng is different from pain in the level of brain perception and the level of subjective concept. It is very likely that sng has its own unique nerve pathway other than pain. The subjective feeling of sng is very similar to sour in taste, so it is likely that acidosis may be involved in the process of sng sensation, especially in the muscle. Delayed onset muscle soreness is a well-known example, and the soreness is dependent on the proton-sensing neurons. Indeed, substantial evidences showed that up to 80% muscle afferents are acid-sensitive but not nociceptors. Therefore, the investigators propose that sng is the perception in the brain when the tissue acidosis is sensed by the somatosensory system, and "sng-ception" is created to indicate the sensation of tissue acidosis. However, the causal connection between the peripheral sngception and the central brain perception of sng is not established. The objective of this proposal is to establish the causal connection between peripheral muscle acidosis and the central brain sng perception. My central hypothesis is that acidosis-evoked sensation in the muscles will cause a central sng perception in the brain. This hypothesis is based on our previous studies that showed sng is different from pain in terms of subjective responses, brain activation areas and clinical impacts. To achieve this goal, two specific aims will be pursued 1. to determine if an acid solution will evokes sng response, and, 2.determining the correlation between the rate of drug application and muscle Sng. Successful establishment of the casual connection between the peripheral muscle acidosis and the central brain sng perception will lead to a more comprehensive understanding of sng mechanism and the potential medication development.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
20 Years 至 45 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • The subject ages ranges from 20-45 years old.
  • The subject has no chronic pain symptoms or complaint in last 6 months.
  • The subject is subjectively able to discriminate sng and pain.
  • The subject has no history of major diseases that required treatment or currently being under treatment.
  • Gender: men and women half
  • The used hand of subject is the right hand.
  • The educational level of subject is more than 9 years (graduated from junior high school)
  • The subject didn't have physical and mental illness
  • The subject didn't take prescribed medicine.
  • The VAS questionnaire must be 0 point both of low back "pain" and low back "soreness" assessment.
  • The subject who can fill the informed consent after understanding the purpose and medical help of this trial.

排除标准

  • The subject has:Neuropathic pain due to causes other than that specified in the inclusion criteria (e.g., post-herpetic neuralgia; painful diabetic neuropathy; mononeuritis multiplex; central poststroke pain; failed back surgery in relation to the presenting episode of radiculopathy; spinal abscess, infection, hematoma, or malignancy; phantom limb pain; peripheral neuropathy due to alcoholism, malignancy, human immunodeficiency virus [HIV], syphilis; drug abuse; vitamin B12 deficiency; hypothyroidism; liver disease; toxic exposure).
  • Pain that is associated with a substantial somatic pain component (e.g., non-neuropathic/musculoskeletal pain in lower limbs or other parts of the body apart from the back) or more than one cause or potential cause for pain symptoms.Any painful concurrent rheumatic disease such as, but not limited to, fibromyalgia, rheumatoid arthritis, or significant osteoarthritis.
  • The subject is unable to reliably delineate or assess his or her own pain by anatomical location/distribution (e.g., the subject cannot reliably tell the difference between his or her back pain and lower limb pain and cannot rate the intensity of each separately).
  • The subject has undergone lumbar spine surgery within the last 6 months or has received treatment with epidural injections, nerve blocks, or acupuncture for LSR within 4 weeks before screening.
  • The subject had a malignancy according to his/her report.
  • The subject has had a positive test for HIV antibody or a history of HIV according to his/her report.
  • The subject has had a positive test for hepatitis B surface antigen or hepatitis C antibody according to his/her report.
  • The subject has a history of alcohol or narcotic substance abuse according to his/her report.
  • The subject is female and is pregnant or breastfeeding at the time of the screening visit or plans to become pregnant during the study period.
  • The subject cannot perform brain MRI scanning who had metal implants of head (such as fixed dentures, metal bone plate, vascular clamp, vascular embolization treatment coil, deep brain stimulator, artificial electronic ear, etc.), implants of head which affecting the image quality (such as the ventricle peritoneal catheter, etc.), implantation of permanent heart rate regulator, etc.
  • The subject has a history of spinal surgery.
  • The VAS questionnaire not be 0 point either low back "pain" or low back "soreness" assessment.
  • The subject has suffered from claustrophobia.
  • The subject has suffered from brain disease and had brain surgery.
  • The subject has taken prescribed medicine which can affect specific function of brian (such as sleeping pills, tranquilizer, etc.).
  • The subject has mental comorbidity (such as depression, panic disorder, etc)
  • The subject has mental retardation.
  • The educational level of subject is less than 9 years.
  • The subject ,who is unable to understand the purpose of this trial and fill the informed consent.

研究组 & 干预措施

Acidic phosphate buffer solution

Experimental

The pH5.2 PBS will be given into the midpoint of the left tibialis muscle with flow rate of 0-40ml/hr for 2-26 minutes, that is, totally 5.5 ml of PBS.

干预措施: Phosphate Buffer Solution (Drug)

Neutral phosphate buffer solution

Placebo Comparator

The pH 7.4 PBS will be given into the midpoint of the left tibialis muscle with flow rate of 0-40ml/hr for 2-26 minutes, that is, totally 5.5 ml of PBS.

干预措施: Phosphate Buffer Solution (Drug)

结局指标

主要结局

The visual analog scale (VAS) of "sng" in the legs

时间窗: Through completion of injection an average of 6 month

The subject will be asked for sng VAS before infusion and immediately after infusion. Scale range 0 to 10 (1)0: No Sng (2)1-3: Mild Sng (3)4-6: Moderate Sng (4)7-9: Severe Sng (5)10: Worst Sng imaginable

The visual analog scale (VAS) of "pain" in the legs

时间窗: Through completion of injection an average of 6 month

The subject will be asked for pain VAS before infusion and immediately after infusion. Scale range 0 to 10 (1)0: No Pain (2)1-3: Mild Pain (3)4-6: Moderate Pain (4)7-9: Severe Pain (5)10: Worst Pain imaginable

次要结局

  • Muscle pressure pain threshold(Through completion of injection an average of 1 week)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jiann-Her,Lin

Principal Investigator

Taipei Medical University Hospital

研究点 (1)

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