Evaluating Acupuncture Relationship With the Catecholaminergic Pathway
Evaluating Acupuncture in the Treatment of Low Back Pain in Athletes and the Relationship With the Catecholaminergic Pathway
1 other identifier
interventional
30
0 countries
N/A
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable low-back-pain
Started Oct 2016
Shorter than P25 for not_applicable low-back-pain
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 16, 2016
CompletedFirst Posted
Study publicly available on registry
August 23, 2016
CompletedStudy Start
First participant enrolled
October 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2017
CompletedAugust 1, 2018
July 1, 2018
3 months
August 16, 2016
July 30, 2018
Conditions
Outcome Measures
Primary Outcomes (2)
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
before Electroacupuncture Time "0"
Levels of catecholamines in serum
Blood was collected into chilled heparin tubes serum catecholamines were determined by ELISA (Rocky Mountain Diagnostics, Colorado Springs, CO)
five minutes before Electroacupuncture
Secondary Outcomes (2)
Levels of catecholamines in serum
five minutes after Electroacupuncture
Visual analogue scale
Five days after Electroacupuncture
Study Arms (3)
Device: Electroacupuncture
EXPERIMENTALThe 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
Device: Sham Electroacupuncture
SHAM COMPARATORIn 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
Drug: Diclofenac sodium
ACTIVE COMPARATOR100 mg Diclofenac sodium was administrated orally every 12 hours for 5 days.
Interventions
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
100 mg Diclofenac sodium was administrated orally every 12 hours for 5 days.
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
Eligibility Criteria
You may qualify if:
- (Controls)
- Healthy
- Non Smokers
- Athletes
- (Cases)
- Acute Low Back Pain (less than 1 month)
- Athletes
- Non Smokers
You may not qualify if:
- Sciatic Pain
- Smokers
- Chronic Low Back Pain
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Lourdes Arriaga Pizano, MD PhD
IMSS
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Full Time Professor Researcher
Study Record Dates
First Submitted
August 16, 2016
First Posted
August 23, 2016
Study Start
October 1, 2016
Primary Completion
January 1, 2017
Study Completion
February 1, 2017
Last Updated
August 1, 2018
Record last verified: 2018-07
Data Sharing
- IPD Sharing
- Will not share