| Purpose: |
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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.
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| Study Summary: |
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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.
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| Criteria: |
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- INCLUSION CRITERIA:
- 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.
EXCLUSION CRITERIA:
- 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.
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