PainNCT01088867
Using Diffuse Noxious Inhibitory Control (DNIC) to Predict Acupuncture Therapy Outcome: A Pilot Study
A study testing Acupuncture in people with Pain, run by University of Washington at 1 site in United States.
Trial summary
The investigators hypothesize that acupuncture modifies the DNIC efficiency and that DNIC can serve as a predictor to identify 'good responders' to acupuncture early in therapy. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain
- What is being tested?
- Acupuncture
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2010to Jul 2010
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy women with a progesterone-coated intrauterine device (Mirena), and
- Men greater than or equal to 18 years old.
Who cannot join
- Acupuncture treatment in the previous six weeks, to discount any persisting effect of acupuncture.
- Treatment of a pain condition with pain medication.
- Regular use of benzodiazepines.
- Skin diseases, such as scleroderma, psoriasis or eczema.
- An adverse event due to acupuncture therapy.
- Pregnant women.
- Women without a progesterone-coated intrauterine device (Mirena).
- Anyone older than 60 years of age, fatigued, with a pacemaker ICD, artificial joint, prolonged bleeding time/hemophilia, open wounds, or a known susceptibility to profound analgesia after acupuncture treatment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Using DNIC to Predict Acupuncture Therapy Outcome: A Pilot Study
The investigators hypothesize that acupuncture modifies the DNIC efficiency and that DNIC can serve as a predictor to identify 'good responders' to acupuncture early in therapy.
- Conditions
- Pain
- Being tested
- Acupuncture
- Keywords
- Pain, Acupuncture, DNIC, Electroacupuncture
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcupunctureOther
Also called Pantheon Electroacupuncture Device
Electroacupuncture
| Study group | Role | What they receive |
|---|---|---|
| Acupuncture | Other | 14 weeks of electroacupuncture therapy. Receives: Other: Acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diffuse Noxious Inhibitory Control Efficiency
The efficiency of diffuse noxious inhibitory control (DNIC) is a measure of one's ability to inhibit pain perception. DNIC efficiency is assessed by a psychophysical test that involves a heat thermode as the "test stimulus" and a warm water bath as the "conditioning stimulus". The results of this test will be used as the primary outcome measure.
Measured: Week 0, 2, 4, 6, and 12 of acupuncture therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2010 (estimated)
- Study startMar 2010
- Primary completionJul 2010
- Study completionJul 2010
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.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- 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
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- Bastyr University
- Responsible party
- Principal investigator, Ruth Landau, University of Washington
- Investigators
- Ruth Landau, MD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01088867
- Sponsor's protocol ID
- 36255-A
- Status last verified
- Jun 2013
- First submitted
- 12 Mar 2010
- Last updated
- 19 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using DNIC to Predict Acupuncture Therapy Outcome: A Pilot Study
- ClinicalTrials.gov ID
- NCT01088867
- Acronym / sponsor ID
- 36255-A
- Conditions
- Pain
- Keywords
- Pain, Acupuncture, DNIC, Electroacupuncture
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- Bastyr University
- Study start
- Mar 2010
- Primary completion
- Jul 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 17 Mar 2010 (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.
The investigators hypothesize that acupuncture modifies the DNIC efficiency and that DNIC can serve as a predictor to identify 'good responders' to acupuncture early in therapy.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Acupuncture | Other | Other: Acupuncture14 weeks of electroacupuncture therapy. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy women with a progesterone-coated intrauterine device (Mirena), and
- Men greater than or equal to 18 years old.
Key exclusion criteria (8 listed)
- Acupuncture treatment in the previous six weeks, to discount any persisting effect of acupuncture.
- Treatment of a pain condition with pain medication.
- Regular use of benzodiazepines.
- Skin diseases, such as scleroderma, psoriasis or eczema.
- An adverse event due to acupuncture therapy.
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 |
|---|---|---|
| AcupunctureAlso: Pantheon Electroacupuncture DeviceElectroacupuncture | Other | Acupuncture |
Primary outcome
Diffuse Noxious Inhibitory Control Efficiency
Time frame: Week 0, 2, 4, 6, and 12 of acupuncture therapy
The efficiency of diffuse noxious inhibitory control (DNIC) is a measure of one's ability to inhibit pain perception. DNIC efficiency is assessed by a psychophysical test that involves a heat thermode as the "test stimulus" and a warm water bath as the "conditioning stimulus". The results of this test will be used as the primary outcome measure.
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 19 Jun 2013.
Related trials for Pain
Not yet recruiting
Digital Use, 24-Hour Movement Behaviors, and Myofascial Release in University Students With Neck Pain
Forward Head Posture, Chronic Nonspecific Neck Pain
Recruiting
Effects of Virtual Reality Exergames Versus Spinal Manipulation in Chronic Nonspecific Low Back Pain
Chronic Nonspecific Low-back Pain, CNSLBP
Recruiting
Dietary Intervention for Migraine Relief
Migraine
RecruitingPhase 4
Anrikefon-based Patient-controlled Intravenous Analgesia Following Laparoscopic Surgery
Laparoscopic Surgery, Visceral Pain, Postoperative
Not yet recruiting
Ultrasound-Guided Radiofrequency Ablation for Focal Adenomyosis
Adenomyosis, Adenomyoma of Uterus
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.
Ruth Landau, MD principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acupuncture in people with Pain, run by University of Washington 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 2 inclusion and 8 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 19 Jun 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?
Diffuse Noxious Inhibitory Control Efficiency (time frame: Week 0, 2, 4, 6, and 12 of acupuncture therapy). 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 19 Jun 2013.