Acupuncture to Reduce Signs of Inflammation in Participants With Chronic Low Back Pain
CompletedPhase 1NCT01376375
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- Official title
- A Pilot Study to Evaluate the Effect of Acupuncture on Epigenetic Regulation of Inflammatory Mediators in Participants With Chronic Low Back Pain
- Conditions
- Interventions
- Sponsor
- National Center for Complementary and Integrative Health (NCCIH)
- Organization
- National Institutes of Health Clinical Center (CC)
- Start date
- 2011-06-10
- Primary completion
- 2013-04-26
- Sex
- All
- Age range
- from 18 Years
- Results posted
- No results posted in this snapshot
- Countries
- United States
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
* 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.
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT01376375