Low Back PainNCT02876432
Evaluating Acupuncture Relationship With the Catecholaminergic Pathway
A study testing Electroacupuncture and Diclofenac sodium in people with Low Back Pain, run by Universidad Autónoma Benito Juárez de Oaxaca.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 30 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Electroacupuncture and Diclofenac sodium
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Oct 2016to Feb 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- (Controls)
- Healthy
- Non Smokers
- Athletes
- (Cases)
- Acute Low Back Pain (less than 1 month)
- Athletes
- Non Smokers
Who cannot join
- Sciatic Pain
- Smokers
- Chronic Low Back Pain
About this study
Official title: Evaluating Acupuncture in the Treatment of Low Back Pain in Athletes and the Relationship With the Catecholaminergic Pathway
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
Read the 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.
- Conditions
- Low Back Pain
- Being tested
- Electroacupuncture, Diclofenac sodium, Sham electroacupuncture
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ElectroacupunctureDevice
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
Diclofenac sodiumDrug
100 mg Diclofenac sodium was administrated orally every 12 hours for 5 days.
Sham electroacupunctureOther
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
| Study group | Role | What they receive |
|---|---|---|
| Device: Electroacupuncture | Experimental | 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 Receives: Device: Electroacupuncture; Other: Sham electroacupuncture |
| Device: Sham Electroacupuncture | Sham comparator | 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 Receives: Device: Electroacupuncture; Other: Sham electroacupuncture |
| Drug: Diclofenac sodium | Active comparator | 100 mg Diclofenac sodium was administrated orally every 12 hours for 5 days. Receives: Drug: Diclofenac sodium |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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)
Measured: five minutes before Electroacupuncture
Secondary outcomes (2)
Levels of catecholamines in serum
Blood was collected into chilled heparin tubes serum catecholamines were determined by ELISA (Rocky Mountain Diagnostics, Colorado Springs, CO)
Measured: five minutes after Electroacupuncture
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
Measured: Five days after Electroacupuncture
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2016 (estimated)
- Study startOct 2016
- Primary completionJan 2017
- Study completionFeb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Autónoma Benito Juárez de Oaxaca
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rafael Torres Rosas, Universidad Autónoma Benito Juárez de Oaxaca
- Investigators
- Lourdes Arriaga Pizano, MD PhD, Study director, IMSS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02876432
- Sponsor's protocol ID
- PEL0011FO
- Status last verified
- Jul 2018
- First submitted
- 16 Aug 2016
- Last updated
- 1 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Acupuncture in the Treatment of Low Back Pain in Athletes and the Relationship With the Catecholaminergic Pathway
- ClinicalTrials.gov ID
- NCT02876432
- Acronym / sponsor ID
- PEL0011FO
- Conditions
- Low Back Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Universidad Autónoma Benito Juárez de OaxacaUniversity, hospital or other
- Study start
- Oct 2016 (actual)
- Primary completion
- Jan 2017 (actual)
- Study completion
- Feb 2017 (actual)
- First posted
- 23 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Device: Electroacupuncture | Experimental | Device: Electroacupuncture, Other: Sham electroacupunctureThe 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 comparator | Device: Electroacupuncture, Other: Sham electroacupunctureIn 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 comparator | Drug: Diclofenac sodium100 mg Diclofenac sodium was administrated orally every 12 hours for 5 days. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- (Controls)
- Healthy
- Non Smokers
- Athletes
- (Cases)
Key exclusion criteria (3 listed)
- Sciatic Pain
- Smokers
- Chronic Low Back Pain
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ElectroacupunctureThe 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 | Device: Electroacupuncture, Device: Sham Electroacupuncture |
| Diclofenac sodium100 mg Diclofenac sodium was administrated orally every 12 hours for 5 days. | Drug | Drug: Diclofenac sodium |
| Sham electroacupunctureThe 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 | Other | Device: Electroacupuncture, Device: Sham Electroacupuncture |
Primary outcome
Visual analogue scale
Time frame: before Electroacupuncture Time "0"
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
Time frame: five minutes before Electroacupuncture
Blood was collected into chilled heparin tubes serum catecholamines were determined by ELISA (Rocky Mountain Diagnostics, Colorado Springs, CO)
2 secondary outcomes
Levels of catecholamines in serum
Time frame: five minutes after Electroacupuncture
Visual analogue scale
Time frame: Five days after Electroacupuncture
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lourdes Arriaga Pizano, MD PhD study director
IMSS
Questions about this trial
What is this clinical trial studying?
A study testing Electroacupuncture and Diclofenac sodium in people with Low Back Pain, run by Universidad Autónoma Benito Juárez de Oaxaca.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual analogue scale (time frame: before Electroacupuncture Time "0"). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2018.