Effect of Flow Rate and PH on Muscle Acidosis

NCT05165277 | Terminated

• 1 other identifier: N201909038
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Muscle Acidosis

Keywords

sngception; soreness; muscle acidosis; flow rate

Outcome Measures

Primary Outcomes (2)

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

  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

  Through completion of injection an average of 6 month

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

  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

  Through completion of injection an average of 6 month

Secondary Outcomes (1)

• Muscle pressure pain threshold

  Through completion of injection an average of 1 week

Other Outcomes (2)

• 36-Item Short Form Health Survey (RAND)

  Up to 6 months before signing the informed consent form

• Oswestry disability index

  Up to 6 months before signing the informed consent form

Study Arms (2)

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.

Drug: Phosphate Buffer Solution

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.

Drug: Phosphate Buffer Solution

Interventions

Phosphate Buffer Solution DRUG

Phosphate-buffered saline (abbreviated PBS) is a buffer solution commonly used in biological research. It is a water-based salt solution containing disodium hydrogen phosphate, sodium dihydrogen phosphate. The buffer helps to maintain a constant pH. The osmolarity and ion concentrations of the solutions match those of the human body (isotonic).

Also known as: Sodium phosphate solution, Phosphate buffered saline

Acidic phosphate buffer solution; Neutral phosphate buffer solution

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Taipei Medical University Hospital: lead

Study Sites (1)

Taipei Medical University Hospital

Taipei, 11031, Taiwan

Location

Related Publications (6)

• Issberner U, Reeh PW, Steen KH. Pain due to tissue acidosis: a mechanism for inflammatory and ischemic myalgia? Neurosci Lett. 1996 Apr 26;208(3):191-4. doi: 10.1016/0304-3940(96)12576-3.

  PMID: 8733302 BACKGROUND

• Law LAF, Sluka KA, McMullen T, Lee J, Arendt-Nielsen L, Graven-Nielsen T. Acidic buffer induced muscle pain evokes referred pain and mechanical hyperalgesia in humans. Pain. 2008 Nov 30;140(2):254-264. doi: 10.1016/j.pain.2008.08.014. Epub 2008 Oct 2.

  PMID: 18835099 BACKGROUND

• Lin JH, Hung CH, Han DS, Chen ST, Lee CH, Sun WZ, Chen CC. Sensing acidosis: nociception or sngception? J Biomed Sci. 2018 Nov 29;25(1):85. doi: 10.1186/s12929-018-0486-5.

  PMID: 30486810 BACKGROUND

• Fujii Y, Ozaki N, Taguchi T, Mizumura K, Furukawa K, Sugiura Y. TRP channels and ASICs mediate mechanical hyperalgesia in models of inflammatory muscle pain and delayed onset muscle soreness. Pain. 2008 Nov 30;140(2):292-304. doi: 10.1016/j.pain.2008.08.013. Epub 2008 Oct 1.

  PMID: 18834667 BACKGROUND

• Chen CC, Wong CW. Neurosensory mechanotransduction through acid-sensing ion channels. J Cell Mol Med. 2013 Mar;17(3):337-49. doi: 10.1111/jcmm.12025. Epub 2013 Mar 14.

  PMID: 23490035 BACKGROUND

• Chen WN, Lee CH, Lin SH, Wong CW, Sun WH, Wood JN, Chen CC. Roles of ASIC3, TRPV1, and NaV1.8 in the transition from acute to chronic pain in a mouse model of fibromyalgia. Mol Pain. 2014 Jun 23;10:40. doi: 10.1186/1744-8069-10-40.

  PMID: 24957987 BACKGROUND

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 7, 2021
• First Posted: December 21, 2021
• Study Start: July 4, 2019
• Primary Completion: January 2, 2020
• Study Completion: December 31, 2023
• Last Updated: November 22, 2024

Record last verified: 2024-11

Locations

TW (1)