PainPhase 1NCT00802165
Effect of Electroacupuncture on Pain Threshold
A Phase 1 study testing Electroacupuncture in people with Pain, run by Logan College of Chiropractic at 1 site in United States.
Trial summary
This study is designed to evaluate whether or not electroacupuncture can have an effect on the pain threshold of the subject, as compared to sham treatment. Read more about this study
- Who is it for?
- Ages 10 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain
- What is being tested?
- Electroacupuncture
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2008to Apr 2009
- Phase
- Phase 1
- 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 10 to 70 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Normal healthy subjects
Who cannot join
- Hypertension
- Heart Disease
- Pregnancy
- No spinal manipulation or other treatment or medication that could effect pain threshold
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Logan College of Chiropractic
Chesterfield, Missouri, 63006
About this study
This study is designed to evaluate whether or not electroacupuncture can have an effect on the pain threshold of the subject, as compared to sham treatment.
Read the detailed description
This study is utilized to evaluate the what effectiveness electroacupuncture has on pain threshold as compared to sham. The outcome measurement utilized will be a digital algometer. The electroacupuncture treatment will consist of a total of four electroacupuncture treatments stimulating acupuncture points LI4 and LI11, and will be given on the same upper extremity tested by the algometer. The algometer measurements will occur alone on the first week, prior to the treatments on the second and third week, and the final reading alone on the fourth week.
- Conditions
- Pain
- Being tested
- Electroacupuncture, Sham electroacupuncture
- Keywords
- Asymptomatic normals
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ElectroacupunctureDevice
Group is given a total of four electroacupuncture treatments to evaluate it's anesthetic effectiveness
Sham electroacupunctureDevice
Sham electroacupuncture treatment gives comparison to the experimental group
| Study group | Role | What they receive |
|---|---|---|
| Electroacupuncture Treatment Group | Experimental | Group is given a total of four electroacupuncture treatments to evaluate it's anesthetic effectiveness Receives: Device: Electroacupuncture |
| Sham Treatment Group | Sham comparator | Sham electroacupuncture treatment gives comparison to the experimental group Receives: Device: Sham electroacupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Digital Algometer
Measured: Four Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2008 (estimated)
- Study startDec 2008
- Primary completionApr 2009 (estimated)
- Study completionApr 2009 (estimated)
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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Logan College of Chiropractic
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00802165
- Sponsor's protocol ID
- SR0806080149
- Status last verified
- Dec 2008
- First submitted
- 3 Dec 2008
- Last updated
- 4 Dec 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Electroacupuncture on Pain Threshold
- ClinicalTrials.gov ID
- NCT00802165
- Acronym / sponsor ID
- SR0806080149
- Conditions
- Pain
- Keywords
- Asymptomatic normals
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Logan College of ChiropracticUniversity, hospital or other
- Study start
- Dec 2008
- Primary completion
- Apr 2009 (estimated)
- Study completion
- Apr 2009 (estimated)
- First posted
- 4 Dec 2008 (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.
This study is designed to evaluate whether or not electroacupuncture can have an effect on the pain threshold of the subject, as compared to sham treatment.
Detailed description
This study is utilized to evaluate the what effectiveness electroacupuncture has on pain threshold as compared to sham. The outcome measurement utilized will be a digital algometer. The electroacupuncture treatment will consist of a total of four electroacupuncture treatments stimulating acupuncture points LI4 and LI11, and will be given on the same upper extremity tested by the algometer. The algometer measurements will occur alone on the first week, prior to the treatments on the second and third week, and the final reading alone on the fourth week.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Electroacupuncture Treatment Group | Experimental | Device: ElectroacupunctureGroup is given a total of four electroacupuncture treatments to evaluate it's anesthetic effectiveness |
| Sham Treatment Group | Sham comparator | Device: Sham electroacupunctureSham electroacupuncture treatment gives comparison to the experimental group |
Who may qualify
- Ages
- 10 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Normal healthy subjects
Key exclusion criteria (4 listed)
- Hypertension
- Heart Disease
- Pregnancy
- No spinal manipulation or other treatment or medication that could effect pain threshold
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 |
|---|---|---|
| ElectroacupunctureGroup is given a total of four electroacupuncture treatments to evaluate it's anesthetic effectiveness | Device | Electroacupuncture Treatment Group |
| Sham electroacupunctureSham electroacupuncture treatment gives comparison to the experimental group | Device | Sham Treatment Group |
Primary outcome
Digital Algometer
Time frame: Four Weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2008.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Electroacupuncture in people with Pain, run by Logan College of Chiropractic 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 4 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: status not confirmed, as of the sponsor's last update on 4 Dec 2008. 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. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact John Zhang, MD, PhD (636-230-1920 ext. 1920, john.zhang@logan.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Digital Algometer (time frame: Four Weeks). 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 4 Dec 2008.