PainPhase 1NCT01376375
Acupuncture to Reduce Signs of Inflammation in Participants With Chronic Low Back Pain
A Phase 1 study testing Acupuncture in people with Pain, run by National Center for Complementary and Integrative Health (NCCIH) at 1 site in United States.
Trial summary
Background: Acupuncture is a traditional Chinese medical treatment. Thin needles are used to stimulate specific points in the body. Previous studies have found that acupuncture can be useful in treating low back pain. This study will explore how acupuncture affects low back pain. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain
- What is being tested?
- Acupuncture
- Type of treatment
- Surgery or procedure
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Jun 2011to 26 Apr 2013
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participant must be greater than or equal to 18 years of age.
- Participant must understand and sign the protocol s informed consent document.
- Participant must have been diagnosed with chronic LBP between 3-12 months prior to enrollment.
- Participant must have LBP of greater than or equal to 3 points on a scale of 0 to 10 recorded on the BPI-SF at enrollment.
- Participant must have a RMDQ score of greater than or equal to 3.
- Participant must be able to comprehend English in order to complete questionnaires.
Who cannot join
- Participant is unable to comply with study procedures or follow-up visits.
- Participant is in another investigational study and actively receiving study therapy for LBP.
- Participant has received prior treatment with acupuncture for any medical conditions.
- Participant used analgesics, such as opiates or tramadol, within 30 days of enrollment.
- Participant has a significant medical or psychiatric condition that would preclude study completion as determined by the investigator.
- Participant has received corticosteroid treatment within 3 months of enrollment.
- Participant is receiving physical therapy, heat therapy, ultrasound, spinal manipulation, cognitive-behavioral therapy, biofeedback or anticonvulsants for his/her LBP.
- Participant has had back surgery.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Official title: A Pilot Study to Evaluate the Effect of Acupuncture on Epigenetic Regulation of Inflammatory Mediators in Participants With Chronic Low Back Pain
Background:
- Acupuncture is a traditional Chinese medical treatment. Thin needles are used to stimulate specific points in the body. Previous studies have found that acupuncture can be useful in treating low back pain. This study will explore how acupuncture affects low back pain. Researchers will look at blood samples for changes in different chemicals related to inflammation and pain.
Read more
Objectives:
- To test the effect of acupuncture on blood chemicals associated with chronic low back pain.
Eligibility:
- People at least 18 years of age who have chronic low back pain.
- Those who have had back surgery or had acupuncture for any medical condition may not participate.
Design:
- This study requires eight visits over 2 to 3 weeks. Each visit will take 1.5 to 2 hours.
- At the first study visit, participants will give a medical history and complete two questionnaires about their low back pain. They will also spend 30 minutes lying down on a bed, relaxing quietly.
- The next visits will occur every 2 to 3 days for the next 2 weeks. Participants will receive 30 minutes of either sham or standard acupuncture. Sham acupuncture will mimic the standard procedure, but no needles will be used. The standard procedure will be performed in the same location. A licensed, experienced acupuncturist will insert small disposable needles into acupuncture sites on the back, arms, and legs. Those in the study will not know whether they are receiving the sham or the standard acupuncture procedure.
- At some visits, participants will provide blood samples for testing. At every visit, participants will complete the questionnaires about low back pain.
Read the detailed description
Objective:
Inflammation and primary mechanical derangements are thought to be the two major causes leading to low back pain (LBP) syndromes. Increasing evidence suggests that cytokines and hormones, including IFN-gamma, IL-17, IL-1beta, IL-6, TNF-alpha, MMP10, NGF, PGE2, NO and IL-8, play critical roles in the pathogenesis of inflammatory LBP. This study will investigate the effect of acupuncture on LBP by measuring serum cytokine and hormone levels before and after treatment in participants. To define the molecular mechanism by which acupuncture affects LBP, histone modification, including H3K4me3 and H3K27me3, as well as methylation patterns of CpG islands on the promoters of selected genes in the peripheral CD4(plus) T cells will be also tested.
Study Population:
Five participants with chronic LBP will receive treatment.
Design:
In this non-randomized, single group pilot study, participants will be given sham acupuncture and subsequently treated with acupuncture for a total of eight visits over the span of 17 days. Blood will be drawn and analyzed at scheduled intervals.
Outcome Measure:
The primary outcome is to investigate the potential effect of acupuncture treatment, as compared to sham acupuncture and quiet relaxation, on the regulation of IFN-gamma and IL-17 in participants with LBP, including the serum level of these two cytokines, frequency of CD4(plus)IFN-gamma(plus) and CD4(plus)IL-17(plus) cells in the peripheral blood, and the patterns of H3K4me3, H3K27me3 and DNA methylation on their promoters in CD4(plus) T cells in response to acupuncture treatment. Secondary outcomes investigate the effects of acupuncture, as compared to sham acupuncture and quiet relaxation, on the following outcome measures: level of serum cytokines and hormones, including IL-1beta, TNF-alpha, MMP10, NGF, PGE2, NO, IL-8, IL-6, TGF-beta, IL-10, IL-22, IL-23 and IL-17F before and after acupuncture treatment; genome-wide gene expression profile of CD4(plus) T cells before and after acupuncture treatment; genome-wide patterns of H3K4me3 and H3K27me3 modification in CD4(plus) T cells before and after acupuncture treatment; genome-wide patterns of H3K4me3 and H3K27me3 modification in CD4(plus)T cells before and after acupuncture treatment; DNA methylation status change of selected CpG islands before and after acupuncture treatment; and the severity of LBP before and after two weeks of acupuncture treatment according to the Brief Pain Inventory-Short Form (BPI-SF) for pain severity, as well as the Randall Morris Disability Questionnaire (RMDQ) for LBP-related interference scores.
- Conditions
- Pain
- Being tested
- Acupuncture
- Keywords
- Acupuncture, Low Back Pain
- Medical subject headings
- Pain, Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcupunctureProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
To investigate the potential effect of acupuncture treatment on epigenetic regulation of inflammatory factors in participants with BP
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2011 (estimated)
- Study start10 Jun 2011
- Primary completion26 Apr 2013
- Study completion26 Apr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- 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
- Non-randomised
- Intervention model
- Single group
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Center for Complementary and Integrative Health (NCCIH)
- Sponsor type
- US National Institutes of Health
- Investigators
- Lai Wei, M.D., Principal investigator, National Eye Institute (NEI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01376375
- Sponsor's protocol ID
- 110188
- Other IDs
- 11-AT-0188
- Status last verified
- 26 Apr 2013
- First submitted
- 17 Jun 2011
- Last updated
- 17 Dec 2019
- Results posted
- No
Publications
Lewis K, Abdi S. Acupuncture for lower back pain: a review. Clin J Pain. 2010 Jan;26(1):60-9. doi: 10.1097/AJP.0b013e3181bad71e.
PubMed 20026956Ross JS. Non-mechanical inflammatory causes of back pain: Current concepts. Skeletal Radiol. 2006 Jul;35(7):485-7. doi: 10.1007/s00256-006-0121-5. No abstract available.
PubMed 16752161Cuellar JM, Golish SR, Reuter MW, Cuellar VG, Angst MS, Carragee EJ, Yeomans DC, Scuderi GJ. Cytokine evaluation in individuals with low back pain using discographic lavage. Spine J. 2010 Mar;10(3):212-8. doi: 10.1016/j.spinee.2009.12.007.
PubMed 20207331
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Evaluate the Effect of Acupuncture on Epigenetic Regulation of Inflammatory Mediators in Participants With Chronic Low Back Pain
- ClinicalTrials.gov ID
- NCT01376375
- Acronym / sponsor ID
- 110188
- Conditions
- Pain
- Keywords
- Acupuncture, Low Back Pain
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- National Center for Complementary and Integrative Health (NCCIH)US National Institutes of Health
- Study start
- 10 Jun 2011
- Primary completion
- 26 Apr 2013 (actual)
- Study completion
- 26 Apr 2013 (actual)
- First posted
- 20 Jun 2011 (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.
Background:
- Acupuncture is a traditional Chinese medical treatment. Thin needles are used to stimulate specific points in the body. Previous studies have found that acupuncture can be useful in treating low back pain. This study will explore how acupuncture affects low back pain. Researchers will look at blood samples for changes in different chemicals related to inflammation and pain.
Objectives:
- To test the effect of acupuncture on blood chemicals associated with chronic low back pain.
Eligibility:
- People at least 18 years of age who have chronic low back pain.
- Those who have had back surgery or had acupuncture for any medical condition may not participate.
Design:
- This study requires eight visits over 2 to 3 weeks. Each visit will take 1.5 to 2 hours.
- At the first study visit, participants will give a medical history and complete two questionnaires about their low back pain. They will also spend 30 minutes lying down on a bed, relaxing quietly.
- The next visits will occur every 2 to 3 days for the next 2 weeks. Participants will receive 30 minutes of either sham or standard acupuncture. Sham acupuncture will mimic the standard procedure, but no needles will be used. The standard procedure will be performed in the same location. A licensed, experienced acupuncturist will insert small disposable needles into acupuncture sites on the back, arms, and legs. Those in the study will not know whether they are receiving the sham or the standard acupuncture procedure.
- At some visits, participants will provide blood samples for testing. At every visit, participants will complete the questionnaires about low back pain.
Detailed description
Objective:
Inflammation and primary mechanical derangements are thought to be the two major causes leading to low back pain (LBP) syndromes. Increasing evidence suggests that cytokines and hormones, including IFN-gamma, IL-17, IL-1beta, IL-6, TNF-alpha, MMP10, NGF, PGE2, NO and IL-8, play critical roles in the pathogenesis of inflammatory LBP. This study will investigate the effect of acupuncture on LBP by measuring serum cytokine and hormone levels before and after treatment in participants. To define the molecular mechanism by which acupuncture affects LBP, histone modification, including H3K4me3 and H3K27me3, as well as methylation patterns of CpG islands on the promoters of selected genes in the peripheral CD4(plus) T cells will be also tested.
Study Population:
Five participants with chronic LBP will receive treatment.
Design:
In this non-randomized, single group pilot study, participants will be given sham acupuncture and subsequently treated with acupuncture for a total of eight visits over the span of 17 days. Blood will be drawn and analyzed at scheduled intervals.
Outcome Measure:
The primary outcome is to investigate the potential effect of acupuncture treatment, as compared to sham acupuncture and quiet relaxation, on the regulation of IFN-gamma and IL-17 in participants with LBP, including the serum level of these two cytokines, frequency of CD4(plus)IFN-gamma(plus) and CD4(plus)IL-17(plus) cells in the peripheral blood, and the patterns of H3K4me3, H3K27me3 and DNA methylation on their promoters in CD4(plus) T cells in response to acupuncture treatment. Secondary outcomes investigate the effects of acupuncture, as compared to sham acupuncture and quiet relaxation, on the following outcome measures: level of serum cytokines and hormones, including IL-1beta, TNF-alpha, MMP10, NGF, PGE2, NO, IL-8, IL-6, TGF-beta, IL-10, IL-22, IL-23 and IL-17F before and after acupuncture treatment; genome-wide gene expression profile of CD4(plus) T cells before and after acupuncture treatment; genome-wide patterns of H3K4me3 and H3K27me3 modification in CD4(plus) T cells before and after acupuncture treatment; genome-wide patterns of H3K4me3 and H3K27me3 modification in CD4(plus)T cells before and after acupuncture treatment; DNA methylation status change of selected CpG islands before and after acupuncture treatment; and the severity of LBP before and after two weeks of acupuncture treatment according to the Brief Pain Inventory-Short Form (BPI-SF) for pain severity, as well as the Randall Morris Disability Questionnaire (RMDQ) for LBP-related interference scores.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Participant must be greater than or equal to 18 years of age.
- Participant must understand and sign the protocol s informed consent document.
- Participant must have been diagnosed with chronic LBP between 3-12 months prior to enrollment.
- Participant must have LBP of greater than or equal to 3 points on a scale of 0 to 10 recorded on the BPI-SF at enrollment.
- Participant must have a RMDQ score of greater than or equal to 3.
Key exclusion criteria (8 listed)
- Participant is unable to comply with study procedures or follow-up visits.
- Participant is in another investigational study and actively receiving study therapy for LBP.
- Participant has received prior treatment with acupuncture for any medical conditions.
- Participant used analgesics, such as opiates or tramadol, within 30 days of enrollment.
- Participant has a significant medical or psychiatric condition that would preclude study completion as determined by the investigator.
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 |
|---|---|---|
| Acupuncture | Procedure or surgery | – |
Primary outcome
To investigate the potential effect of acupuncture treatment on epigenetic regulation of inflammatory factors in participants with BP
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 Dec 2019.
- Background: PubMed 20026956Lewis K, Abdi S. Acupuncture for lower back pain: a review. Clin J Pain. 2010 Jan;26(1):60-9. doi: 10.1097/AJP.0b013e3181bad71e.
- Background: PubMed 16752161Ross JS. Non-mechanical inflammatory causes of back pain: Current concepts. Skeletal Radiol. 2006 Jul;35(7):485-7. doi: 10.1007/s00256-006-0121-5. No abstract available.
- Background: PubMed 20207331Cuellar JM, Golish SR, Reuter MW, Cuellar VG, Angst MS, Carragee EJ, Yeomans DC, Scuderi GJ. Cytokine evaluation in individuals with low back pain using discographic lavage. Spine J. 2010 Mar;10(3):212-8. doi: 10.1016/j.spinee.2009.12.007.
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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.
Lai Wei, M.D. principal investigator
National Eye Institute (NEI)
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 Acupuncture in people with Pain, run by National Center for Complementary and Integrative Health (NCCIH) 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 6 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 17 Dec 2019. 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.
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?
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?
To investigate the potential effect of acupuncture treatment on epigenetic regulation of inflammatory factors in participants with BP. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01376375, which also lists 3 linked publications.
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 Dec 2019.