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Evaluating Acupuncture Relationship With the Catecholaminergic Pathway

Primary Purpose

Low Back Pain

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Electroacupuncture
Diclofenac sodium
Sham electroacupuncture
Sponsored by
Universidad Autónoma Benito Juárez de Oaxaca
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Low Back Pain

Eligibility Criteria

18 Years - 30 Years (Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

(Controls)

  • Healthy
  • Non Smokers
  • Athletes

(Cases)

  • Acute Low Back Pain (less than 1 month)
  • Athletes
  • Non Smokers

Exclusion Criteria:

  • Sciatic Pain
  • Smokers
  • Chronic Low Back Pain

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Sham Comparator

    Active Comparator

    Arm Label

    Device: Electroacupuncture

    Device: Sham Electroacupuncture

    Drug: Diclofenac sodium

    Arm Description

    The acupuncture points selected were ST36, BL25, GB30, BL40, GB34 the needles were inserted into acupoints and the depth of needle insertion depended of the acupoints selected to achieve Deqi sensation, which is characterized as a numb, heavy, sore and/or distending sensation. Electrical stimulation was delivered at 4 Hz. The stimulator (ITO EST-160) was then switched on, and the intensity was gradually increased to reach a strong but comfortable level the sensation of EA which is characterized for numbness, tingling and a light muscle cramp. For 15 minutes

    In sham electroacupuncture (Sham) the investigators use 1.0 cm outside point of the real electroacupuncture, the depth of needle insertion was superficial to avoid Deqi sensation, the cables wasn't connected to the electro stimulator and was then switched on for 15 minutes. The participants were threaded separately to avoid sharing experiences about the electroacupuncture sessions

    100 mg Diclofenac sodium was administrated orally every 12 hours for 5 days.

    Outcomes

    Primary Outcome Measures

    Visual analogue scale
    in a horizontal line, 100 mm in length, anchored by word descriptors at each end. The patient marks on the line the point that they feel represents their perception of their current state. The VAS score is determined by measuring in millimetres from the left hand end of the line to the point that the patient marks
    Levels of catecholamines in serum
    Blood was collected into chilled heparin tubes serum catecholamines were determined by ELISA (Rocky Mountain Diagnostics, Colorado Springs, CO)

    Secondary Outcome Measures

    Levels of catecholamines in serum
    Blood was collected into chilled heparin tubes serum catecholamines were determined by ELISA (Rocky Mountain Diagnostics, Colorado Springs, CO)
    Visual analogue scale
    in a horizontal line, 100 mm in length, anchored by word descriptors at each end. The patient marks on the line the point that they feel represents their perception of their current state. The VAS score is determined by measuring in millimetres from the left hand end of the line to the point that the patient marks

    Full Information

    First Posted
    August 16, 2016
    Last Updated
    July 30, 2018
    Sponsor
    Universidad Autónoma Benito Juárez de Oaxaca
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02876432
    Brief Title
    Evaluating Acupuncture Relationship With the Catecholaminergic Pathway
    Official Title
    Evaluating Acupuncture in the Treatment of Low Back Pain in Athletes and the Relationship With the Catecholaminergic Pathway
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    October 2016 (Actual)
    Primary Completion Date
    January 2017 (Actual)
    Study Completion Date
    February 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Universidad Autónoma Benito Juárez de Oaxaca

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Activation of the sympathetic nervous system attenuates inflammation via catecholamines, recent advances in electroacupuncture allow activating critical neuronal networks with the release of catecholamines the aim of this research was to evaluate de effect of electroacupuncture in the activation of sympathetic nervous system and the control of low back pain in athletes
    Detailed Description
    Activation of the sympathetic nervous system attenuates inflammation via activation of β2-adrenoreceptors by catecholamines, Electrical stimulation of vagus nerve limits the inflammatory response in several animal models of inflammatory diseases, In addition, voluntary activation of the sympathetic nervous system by meditation, training or breathing techniques limits production of proinflammatory cytokines in vivo during experimental endotoxemia in healthy human volunteers. Currently there are therapies that effectively antagonize proinflammatory cytokines and control pain, as non-steroidal anti-inflammatory drugs and opioid analgesics, but had serious side effects if used chronically. Therefore, alternative therapies as electroacupuncture, which may limit inflammatory cytokine production more physiologically, are warranted. The aim of this study was to evaluate de effect of electroacupuncture used for attenuation of low back pain in the activation of sympathetic nervous system and leukocyte inflammatory potential.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Low Back Pain

    7. Study Design

    Primary Purpose
    Basic Science
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    30 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Device: Electroacupuncture
    Arm Type
    Experimental
    Arm Description
    The acupuncture points selected were ST36, BL25, GB30, BL40, GB34 the needles were inserted into acupoints and the depth of needle insertion depended of the acupoints selected to achieve Deqi sensation, which is characterized as a numb, heavy, sore and/or distending sensation. Electrical stimulation was delivered at 4 Hz. The stimulator (ITO EST-160) was then switched on, and the intensity was gradually increased to reach a strong but comfortable level the sensation of EA which is characterized for numbness, tingling and a light muscle cramp. For 15 minutes
    Arm Title
    Device: Sham Electroacupuncture
    Arm Type
    Sham Comparator
    Arm Description
    In sham electroacupuncture (Sham) the investigators use 1.0 cm outside point of the real electroacupuncture, the depth of needle insertion was superficial to avoid Deqi sensation, the cables wasn't connected to the electro stimulator and was then switched on for 15 minutes. The participants were threaded separately to avoid sharing experiences about the electroacupuncture sessions
    Arm Title
    Drug: Diclofenac sodium
    Arm Type
    Active Comparator
    Arm Description
    100 mg Diclofenac sodium was administrated orally every 12 hours for 5 days.
    Intervention Type
    Device
    Intervention Name(s)
    Electroacupuncture
    Intervention Description
    The acupuncture points selected were ST36, BL25, GB30, BL40, GB34 the needles were inserted into acupoints and the depth of needle insertion depended of the acupoints selected to achieve Deqi sensation, which is characterized as a numb, heavy, sore and/or distending sensation. Electrical stimulation was delivered at 4 Hz. The stimulator (ITO EST-160) was then switched on, and the intensity was gradually increased to reach a strong but comfortable level the sensation of EA which is characterized for numbness, tingling and a light muscle cramp. For 15 minutes
    Intervention Type
    Drug
    Intervention Name(s)
    Diclofenac sodium
    Intervention Description
    100 mg Diclofenac sodium was administrated orally every 12 hours for 5 days.
    Intervention Type
    Other
    Intervention Name(s)
    Sham electroacupuncture
    Intervention Description
    The investigators use 1.0 cm outside point of the real electroacupuncture, the depth of needle insertion was superficial to avoid Deqi sensation, the cables wasn't connected to the electro stimulator and was then switched on for 15 minutes. The participants were threaded separately to avoid sharing experiences about the electroacupuncture sessions
    Primary Outcome Measure Information:
    Title
    Visual analogue scale
    Description
    in a horizontal line, 100 mm in length, anchored by word descriptors at each end. The patient marks on the line the point that they feel represents their perception of their current state. The VAS score is determined by measuring in millimetres from the left hand end of the line to the point that the patient marks
    Time Frame
    before Electroacupuncture Time "0"
    Title
    Levels of catecholamines in serum
    Description
    Blood was collected into chilled heparin tubes serum catecholamines were determined by ELISA (Rocky Mountain Diagnostics, Colorado Springs, CO)
    Time Frame
    five minutes before Electroacupuncture
    Secondary Outcome Measure Information:
    Title
    Levels of catecholamines in serum
    Description
    Blood was collected into chilled heparin tubes serum catecholamines were determined by ELISA (Rocky Mountain Diagnostics, Colorado Springs, CO)
    Time Frame
    five minutes after Electroacupuncture
    Title
    Visual analogue scale
    Description
    in a horizontal line, 100 mm in length, anchored by word descriptors at each end. The patient marks on the line the point that they feel represents their perception of their current state. The VAS score is determined by measuring in millimetres from the left hand end of the line to the point that the patient marks
    Time Frame
    Five days after Electroacupuncture

    10. Eligibility

    Sex
    Male
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    30 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: (Controls) Healthy Non Smokers Athletes (Cases) Acute Low Back Pain (less than 1 month) Athletes Non Smokers Exclusion Criteria: Sciatic Pain Smokers Chronic Low Back Pain
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Lourdes Arriaga Pizano, MD PhD
    Organizational Affiliation
    IMSS
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Evaluating Acupuncture Relationship With the Catecholaminergic Pathway

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