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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT01376375 |
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Date of registration:
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17/06/2011 |
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Primary sponsor: |
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Public title:
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Acupuncture to Reduce Signs of Inflammation in Participants With Chronic Low Back Pain
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Scientific title:
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A Pilot Study to Evaluate the Effect of Acupuncture on Epigenetic Regulation of Inflammatory Mediators in Participants With Chronic Low Back Pain |
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Date of first enrolment:
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June 2011 |
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Target sample size:
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2 |
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Recruitment status: |
Active, not recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT01376375 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind, Primary Purpose: Treatment
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Countries of recruitment
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United States
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Contacts
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Name:
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Lai Wei, M.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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National Eye Institute (NEI) |
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Key inclusion & exclusion 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.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Pain
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Intervention(s)
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Procedure: Acupuncture
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Primary Outcome(s)
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To investigate the potential effect of acupuncture treatment on epigenetic regulation of inflammatory factors in participants with BP
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Secondary ID(s)
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11-AT-0188
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110188
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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