PainNCT01945190
Acupuncture for Inflammatory Pain and Central Sensitization - A Pilot Study
A study testing Electroacupuncture in people with Pain and Inflammation, run by University of Vermont at 1 site in United States.
Trial summary
Acupuncture is used extensively by patients worldwide for a variety of illnesses. While research is beginning to show effectiveness in clinical pain, the mechanisms underlying how these effects are evoked are poorly understood. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain, Inflammation
- What is being tested?
- Electroacupuncture
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2013to Oct 2013
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults aged 18-70
Who cannot join
- Clinically relevant systemic diseases such as psychiatric, neurological, and dermatological conditions interfering with the collection and interpretation of study data
- Chronic or recent use of medication potentially interfering with pain processing (except oral contraceptives)
- Intake of analgesics within the two days prior to study
- Participation in other research studies within the previous 30 days
- Having previously received acupuncture treatments
Trial locations and contacts
1 site in 1 country.
About this study
Acupuncture is used extensively by patients worldwide for a variety of illnesses. While research is beginning to show effectiveness in clinical pain, the mechanisms underlying how these effects are evoked are poorly understood. Experimental models in healthy human volunteers can more closely control the variables of acupuncture needling and begin to separate out the relative contribution of specific components of needling and needle stimulation. By examining acupuncture's effects on experimental inflammatory models with well-characterized physiologic mechanisms, hypotheses can begin to be generated regarding how acupuncture produces its clinical effects. We propose to establish a model which could be used as a template to examine the individual components contributing to acupuncture's clinical effects on inflammation and pain. We hypothesize that acupuncture will have analgesic and anti-inflammatory effects on a ultraviolet B induced cutaneous lesion as well as a model of heat pain testing which activates central sensitization.
Twenty healthy human volunteers will participate in a crossover study with active acupuncture and sham acupuncture interventions. They will be tested for their minimal erythemal dose (MED) to ultraviolet B exposure. An experimental lesion at 3x MED will be administered on the lower leg. Background information will be collected which could affect individuals' sensitivity to pain such as anxiety and depression, as well as their expectations regarding acupuncture treatment.
Read more
The following day they will return for the first experimental day. A measurement with Laser Doppler will quantify the inflammation in the ultraviolet B lesion. Heat pain testing will be performed using a computer controlled thermode both on and off the ultraviolet B lesion. On-lesion testing will be for heat pain threshold. Off-lesion testing will examine temporal summation of heat pain.
Next, a licensed acupuncturist will perform either true electroacupuncture or sham electroacupuncture in the region adjacent to the ultraviolet B lesion. Participants are blinded to the intervention, as is the examiner collecting data. Afterwards, Laser Doppler and heat pain testing will be repeated. The difference between pre-acupuncture and post-acupuncture measurements will represent the acupuncture -induced analgesic and anti-inflammatory effects.
Participants will return for another ultraviolet B exposure adjacent to the first, and will receive whichever sham or true acupuncture intervention was not performed on the first study day.
- Conditions
- Pain, Inflammation
- Being tested
- Electroacupuncture
- Medical subject headings
- Pain, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ElectroacupunctureDevice
| Study group | Role | What they receive |
|---|---|---|
| True before sham electroacupuncture | Experimental | Crossover design, individuals randomized to receive either true or sham acupuncture in first study day, and on the second study day whichever intervention was not administered on the first study day. Receives: Device: Electroacupuncture |
| Sham before true electroacupuncture | Experimental | Crossover design, individuals randomized to receive either true or sham acupuncture in first study day, and on the second study day whichever intervention was not administered on the first study day. Receives: Device: Electroacupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Erythema as measured by Laser Doppler
Participants are studied in two separate sessions each contained within one day, and each lasting approximately 3 hours. Participants' pre-acupuncture treatment data are compared to post-acupuncture data to assess effect of acupuncture
Measured: within one day
Heat pain threshold (deg C)
Participants are studied in two separate sessions each contained within one day, and each lasting approximately 3 hours. Participants' pre-acupuncture treatment data are compared to post-acupuncture data to assess effect of acupuncture
Measured: within one day
Analgesia to temporal summation of heat pain
Temporal summation of pain is an increased magnitude of response to repetitive stimulus administration. Participants are studied in two separate sessions each contained within one day, and each lasting approximately 3 hours. Participants' pre-acupuncture treatment data are compared to post-acupuncture data to assess effect of acupuncture
Measured: within one day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2013 (estimated)
- Study startSep 2013
- Primary completionOct 2013
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Vermont
- Sponsor type
- University, hospital or other
- Collaborators
- Stanford University
- Responsible party
- Principal investigator, Nicholas Phillips, University of Vermont
- Investigators
- Nicholas Phillips, BS, BA, MTOM, Principal investigator, University of VermontHelene Langevin, MD, Study director, University of Vermont
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01945190
- Sponsor's protocol ID
- 14-079
- Other IDs
- 28064
- Status last verified
- Oct 2013
- First submitted
- 4 Sep 2013
- Last updated
- 17 Oct 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acupuncture for Inflammatory Pain and Central Sensitization - A Pilot Study
- ClinicalTrials.gov ID
- NCT01945190
- Acronym / sponsor ID
- 14-079
- Conditions
- Pain, Inflammation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University of VermontUniversity, hospital or other
- Collaborators
- Stanford University
- Study start
- Sep 2013
- Primary completion
- Oct 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 18 Sep 2013 (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.
Acupuncture is used extensively by patients worldwide for a variety of illnesses. While research is beginning to show effectiveness in clinical pain, the mechanisms underlying how these effects are evoked are poorly understood. Experimental models in healthy human volunteers can more closely control the variables of acupuncture needling and begin to separate out the relative contribution of specific components of needling and needle stimulation. By examining acupuncture's effects on experimental inflammatory models with well-characterized physiologic mechanisms, hypotheses can begin to be generated regarding how acupuncture produces its clinical effects. We propose to establish a model which could be used as a template to examine the individual components contributing to acupuncture's clinical effects on inflammation and pain. We hypothesize that acupuncture will have analgesic and anti-inflammatory effects on a ultraviolet B induced cutaneous lesion as well as a model of heat pain testing which activates central sensitization.
Twenty healthy human volunteers will participate in a crossover study with active acupuncture and sham acupuncture interventions. They will be tested for their minimal erythemal dose (MED) to ultraviolet B exposure. An experimental lesion at 3x MED will be administered on the lower leg. Background information will be collected which could affect individuals' sensitivity to pain such as anxiety and depression, as well as their expectations regarding acupuncture treatment.
The following day they will return for the first experimental day. A measurement with Laser Doppler will quantify the inflammation in the ultraviolet B lesion. Heat pain testing will be performed using a computer controlled thermode both on and off the ultraviolet B lesion. On-lesion testing will be for heat pain threshold. Off-lesion testing will examine temporal summation of heat pain.
Next, a licensed acupuncturist will perform either true electroacupuncture or sham electroacupuncture in the region adjacent to the ultraviolet B lesion. Participants are blinded to the intervention, as is the examiner collecting data. Afterwards, Laser Doppler and heat pain testing will be repeated. The difference between pre-acupuncture and post-acupuncture measurements will represent the acupuncture -induced analgesic and anti-inflammatory effects.
Participants will return for another ultraviolet B exposure adjacent to the first, and will receive whichever sham or true acupuncture intervention was not performed on the first study day.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| True before sham electroacupuncture | Experimental | Device: ElectroacupunctureCrossover design, individuals randomized to receive either true or sham acupuncture in first study day, and on the second study day whichever intervention was not administered on the first study day. |
| Sham before true electroacupuncture | Experimental | Device: ElectroacupunctureCrossover design, individuals randomized to receive either true or sham acupuncture in first study day, and on the second study day whichever intervention was not administered on the first study day. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adults aged 18-70
Key exclusion criteria (5 listed)
- Clinically relevant systemic diseases such as psychiatric, neurological, and dermatological conditions interfering with the collection and interpretation of study data
- Chronic or recent use of medication potentially interfering with pain processing (except oral contraceptives)
- Intake of analgesics within the two days prior to study
- Participation in other research studies within the previous 30 days
- Having previously received acupuncture treatments
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 |
|---|---|---|
| Electroacupuncture | Device | Sham before true electroacupuncture, True before sham electroacupuncture |
Primary outcome
Erythema as measured by Laser Doppler
Time frame: within one day
Participants are studied in two separate sessions each contained within one day, and each lasting approximately 3 hours. Participants' pre-acupuncture treatment data are compared to post-acupuncture data to assess effect of acupuncture
Heat pain threshold (deg C)
Time frame: within one day
Participants are studied in two separate sessions each contained within one day, and each lasting approximately 3 hours. Participants' pre-acupuncture treatment data are compared to post-acupuncture data to assess effect of acupuncture
Analgesia to temporal summation of heat pain
Time frame: within one day
Temporal summation of pain is an increased magnitude of response to repetitive stimulus administration. Participants are studied in two separate sessions each contained within one day, and each lasting approximately 3 hours. Participants' pre-acupuncture treatment data are compared to post-acupuncture data to assess effect of acupuncture
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 17 Oct 2013.
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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.
Nicholas Phillips, BS, BA, MTOM principal investigator
University of Vermont
Helene Langevin, MD study director
University of Vermont
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electroacupuncture in people with Pain and Inflammation, run by University of Vermont at 1 site in United States.
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 1 inclusion and 5 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 17 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
Erythema as measured by Laser Doppler (time frame: within one day). The study lists 3 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 17 Oct 2013.